nct_id
stringlengths 11
11
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stringlengths 10
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stringlengths 10
10
⌀ | disposition_first_submitted_date
stringclasses 493
values | last_update_submitted_date
stringlengths 10
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stringlengths 10
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stringlengths 10
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stringclasses 2
values | results_first_submitted_qc_date
stringlengths 10
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stringlengths 10
10
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values | disposition_first_submitted_qc_date
stringclasses 321
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stringclasses 478
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10
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values | start_month_year
stringlengths 7
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⌀ | start_date_type
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values | start_date
stringlengths 10
10
⌀ | verification_month_year
stringclasses 151
values | verification_date
stringclasses 151
values | completion_month_year
stringlengths 7
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values | completion_date
stringlengths 10
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stringlengths 7
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values | primary_completion_date
stringlengths 10
10
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float64 | study_type
stringclasses 1
value | acronym
stringlengths 2
14
⌀ | baseline_population
stringlengths 2
501
⌀ | brief_title
stringlengths 18
300
| official_title
stringlengths 28
563
⌀ | overall_status
stringclasses 4
values | last_known_status
float64 | phase
stringclasses 7
values | enrollment
float64 0
477k
| enrollment_type
stringclasses 2
values | source
stringlengths 3
107
| limitations_and_caveats
stringlengths 10
503
⌀ | number_of_arms
float64 1
27
⌀ | number_of_groups
float64 | why_stopped
stringlengths 3
252
⌀ | has_expanded_access
stringclasses 2
values | expanded_access_type_individual
float64 | expanded_access_type_intermediate
float64 | expanded_access_type_treatment
float64 | has_dmc
stringclasses 2
values | is_fda_regulated_drug
stringclasses 2
values | is_fda_regulated_device
stringclasses 2
values | is_unapproved_device
stringclasses 1
value | is_ppsd
float64 | is_us_export
stringclasses 2
values | biospec_retention
float64 | biospec_description
float64 | ipd_time_frame
stringclasses 442
values | ipd_access_criteria
stringclasses 465
values | ipd_url
stringclasses 124
values | plan_to_share_ipd
stringclasses 3
values | plan_to_share_ipd_description
stringlengths 3
998
⌀ | created_at
stringclasses 526
values | updated_at
stringclasses 526
values | source_class
stringclasses 8
values | delayed_posting
float64 | expanded_access_nctid
stringclasses 80
values | expanded_access_status_for_nctid
stringclasses 4
values | fdaaa801_violation
float64 | baseline_type_units_analyzed
stringclasses 11
values | patient_registry
float64 | completion_year
int64 2.02k
2.02k
| labels
float64 0
1
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT03710564
| null |
2018-10-16
|
2022-06-28
|
2021-10-12
|
2023-01-27
|
2018-10-16
|
2018-10-18
|
ACTUAL
|
2022-06-28
|
2022-07-22
|
ACTUAL
|
2021-10-12
|
2021-10-15
|
ACTUAL
|
2023-01-27
|
2023-01-30
|
ACTUAL
|
2018-10-30
|
ACTUAL
|
2018-10-30
|
2023-01
|
2023-01-31
|
2021-07-01
|
ACTUAL
|
2021-07-01
|
2020-12-21
|
ACTUAL
|
2020-12-21
| null |
INTERVENTIONAL
|
MERLIN
| null |
Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections
|
A Multicenter, Randomized, Double-masked Phase 3a Study to Assess Safety and Efficacy of Brolucizumab 6 mg q4 Weeks Compared to Aflibercept 2 mg q4 Weeks in Patients With Neovascular Age-related Macular Degeneration (nAMD) With Persistent Retinal Fluid (MERLIN)
|
TERMINATED
| null |
PHASE3
| 535 |
ACTUAL
|
Novartis
| null | 2 | null |
Sponsor Decision
|
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null | null | null |
https://www.clinicalstudydatarequest.com
|
YES
|
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
|
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
INDUSTRY
| null | null | null | null | null | null | 2,021 | 0 |
NCT05304663
| null |
2022-02-24
| null | null |
2024-04-05
|
2022-03-30
|
2022-03-31
|
ACTUAL
| null | null | null | null | null | null |
2024-04-05
|
2024-04-08
|
ACTUAL
|
2022-06-01
|
ESTIMATED
|
2022-06-01
|
2024-04
|
2024-04-30
|
2024-12-31
|
ESTIMATED
|
2024-12-31
|
2024-12-31
|
ESTIMATED
|
2024-12-31
| null |
INTERVENTIONAL
|
GLIOASTRA
| null |
Safety and Efficacy of Different Administration Sequences of L19TNF With Lomustine in Glioblastoma at First Progression
|
A Study to Evaluate the Safety and Efficacy of Different Administration Sequences of L19TNF in Combination With Lomustine in Patients With Glioblastoma at First Progression
|
WITHDRAWN
| null |
PHASE1
| 0 |
ACTUAL
|
Philogen S.p.A.
| null | 2 | null |
The Sponsor had no further plan for the study in object
|
f
| null | null | null |
t
|
f
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
INDUSTRY
| null | null | null | null | null | null | 2,024 | 0 |
NCT05000450
| null |
2021-08-04
| null | null |
2024-06-27
|
2021-08-04
|
2021-08-11
|
ACTUAL
| null | null | null | null | null | null |
2024-06-27
|
2024-06-28
|
ACTUAL
|
2021-06-06
|
ACTUAL
|
2021-06-06
|
2024-06
|
2024-06-30
|
2023-10-11
|
ACTUAL
|
2023-10-11
|
2023-10-11
|
ACTUAL
|
2023-10-11
| null |
INTERVENTIONAL
| null | null |
Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
|
A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti- BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
|
TERMINATED
| null |
PHASE1/PHASE2
| 6 |
ACTUAL
|
Allogene Therapeutics
| null | 1 | null |
Terminated (Halted Prematurely)
|
f
| null | null | null | null |
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
INDUSTRY
| null | null | null | null | null | null | 2,023 | 0 |
NCT04310579
| null |
2020-03-09
|
2022-10-12
| null |
2024-05-14
|
2020-03-12
|
2020-03-17
|
ACTUAL
|
2024-05-14
|
2024-05-21
|
ACTUAL
| null | null | null |
2024-05-14
|
2024-05-21
|
ACTUAL
|
2020-06-15
|
ACTUAL
|
2020-06-15
|
2023-11
|
2023-11-30
|
2021-05-25
|
ACTUAL
|
2021-05-25
|
2021-05-25
|
ACTUAL
|
2021-05-25
| null |
INTERVENTIONAL
| null | null |
Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation
|
Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation
|
COMPLETED
| null |
PHASE1
| 55 |
ACTUAL
|
Food and Drug Administration (FDA)
| null | 3 | null | null |
f
| null | null | null |
f
|
t
|
f
| null | null |
f
| null | null | null | null | null |
YES
|
Plan is to make data from the study publicly available as part of a manuscript publication. In addition, the protocol and statistical analysis plan will be made available online at this site as well as any eventual publications.
|
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
FED
| null | null | null | null | null | null | 2,021 | 1 |
NCT02355535
| null |
2015-01-30
| null | null |
2020-09-22
|
2015-02-03
|
2015-02-04
|
ESTIMATED
| null | null | null | null | null | null |
2020-09-22
|
2020-09-24
|
ACTUAL
|
2015-02
|
ACTUAL
|
2015-02-28
|
2020-09
|
2020-09-30
|
2020-05-18
|
ACTUAL
|
2020-05-18
|
2020-05-18
|
ACTUAL
|
2020-05-18
| null |
INTERVENTIONAL
| null | null |
Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1
|
(STM-03) Phase I Study of Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1
|
COMPLETED
| null |
PHASE1
| 48 |
ACTUAL
|
Vanquish Oncology, Inc.
| null | 1 | null | null |
f
| null | null | null |
t
| null | null | null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
INDUSTRY
| null | null | null | null | null | null | 2,020 | 1 |
NCT03489265
| null |
2018-03-09
| null | null |
2019-07-23
|
2018-04-03
|
2018-04-05
|
ACTUAL
| null | null | null | null | null | null |
2019-07-23
|
2019-07-25
|
ACTUAL
|
2019-04
|
ESTIMATED
|
2019-04-30
|
2019-07
|
2019-07-31
|
2020-03
|
ESTIMATED
|
2020-03-31
|
2019-09
|
ESTIMATED
|
2019-09-30
| null |
INTERVENTIONAL
|
ELXDFI
| null |
Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence
|
Treatment of Diarrhea-Associated Fecal Incontinence With Eluxadoline
|
WITHDRAWN
| null |
PHASE2
| 0 |
ACTUAL
|
University of North Carolina, Chapel Hill
| null | 2 | null |
Difficult to recruit severely affected patients with fecal incontinence
|
f
| null | null | null |
t
|
t
|
f
| null | null |
f
| null | null |
9-36 months following publication of the study results.
|
Requester must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IED), or Research Ethics Board (REB), and requester has executed an acceptable data use/sharing agreement with UNC.
|
https://irbis2.research.unc.edu/irb/
|
YES
|
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and executes a data use/sharing agreement with the University of North Carolina.
|
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
OTHER
| null | null | null | null | null | null | 2,020 | 0 |
NCT03437746
| null |
2018-02-13
| null | null |
2022-09-13
|
2018-02-13
|
2018-02-19
|
ACTUAL
| null | null | null | null | null | null |
2022-09-13
|
2022-09-15
|
ACTUAL
|
2018-03-01
|
ACTUAL
|
2018-03-01
|
2022-09
|
2022-09-30
|
2021-11-24
|
ACTUAL
|
2021-11-24
|
2021-09-30
|
ACTUAL
|
2021-09-30
| null |
INTERVENTIONAL
|
CORTICOLON
| null |
Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study
|
Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study
|
TERMINATED
| null |
PHASE2
| 78 |
ACTUAL
|
Centre Hospitalier Universitaire Dijon
| null | null | null |
insufficient rate of inclusion
|
f
| null | null | null | null |
f
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
OTHER
| null | null | null | null | null | null | 2,021 | 0 |
NCT05159128
| null |
2021-12-06
| null | null |
2022-02-04
|
2021-12-06
|
2021-12-15
|
ACTUAL
| null | null | null | null | null | null |
2022-02-04
|
2022-02-22
|
ACTUAL
|
2021-11-15
|
ACTUAL
|
2021-11-15
|
2022-02
|
2022-02-28
|
2022-04-02
|
ESTIMATED
|
2022-04-02
|
2022-04-02
|
ESTIMATED
|
2022-04-02
| null |
INTERVENTIONAL
| null | null |
A Study of JNJ-75105186 in Healthy Japanese and Chinese Participants
|
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-75105186 in Healthy Japanese Participants and a Single Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-75105186 in Healthy Chinese Participants
|
WITHDRAWN
| null |
PHASE1
| 0 |
ACTUAL
|
Janssen Pharmaceutical K.K.
| null | 2 | null |
Business Decision
|
f
| null | null | null |
f
|
f
|
f
| null | null | null | null | null | null | null |
https://www.janssen.com/clinical-trials/transparency
|
YES
|
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
|
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
INDUSTRY
| null | null | null | null | null | null | 2,022 | 0 |
NCT02049866
| null |
2014-01-28
|
2021-03-30
| null |
2022-11-15
|
2014-01-28
|
2014-01-30
|
ESTIMATED
|
2021-03-30
|
2021-04-21
|
ACTUAL
| null | null | null |
2022-11-15
|
2022-12-12
|
ACTUAL
|
2014-11-19
|
ACTUAL
|
2014-11-19
|
2022-10
|
2022-10-31
|
2021-12-23
|
ACTUAL
|
2021-12-23
|
2020-03-31
|
ACTUAL
|
2020-03-31
| null |
INTERVENTIONAL
| null | null |
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
|
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP)
|
COMPLETED
| null |
PHASE2
| 33 |
ACTUAL
|
Columbia University
| null | 1 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
OTHER
| null | null | null | null | null | null | 2,021 | 1 |
NCT05451017
| null |
2022-06-27
| null | null |
2024-07-11
|
2022-07-07
|
2022-07-11
|
ACTUAL
| null | null | null | null | null | null |
2024-07-11
|
2024-07-12
|
ACTUAL
|
2023-01-04
|
ACTUAL
|
2023-01-04
|
2024-07
|
2024-07-31
|
2023-06-28
|
ACTUAL
|
2023-06-28
|
2023-06-26
|
ACTUAL
|
2023-06-26
| null |
INTERVENTIONAL
| null | null |
The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers
|
The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers
|
TERMINATED
| null |
PHASE1
| 24 |
ACTUAL
|
Aelis Farma
| null | 2 | null |
Study was initially paused due to a research hold of the institution. However, the study will not continue as the sample size of patients collected prior to the pause allowed for adequate data analysis of the study endpoints.
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
INDUSTRY
| null | null | null | null | null | null | 2,023 | 0 |
NCT03720990
| null |
2018-10-24
|
2023-09-30
| null |
2024-04-26
|
2018-10-24
|
2018-10-26
|
ACTUAL
|
2023-11-21
|
2023-12-13
|
ACTUAL
| null | null | null |
2024-04-26
|
2024-04-30
|
ACTUAL
|
2021-03-27
|
ACTUAL
|
2021-03-27
|
2024-04
|
2024-04-30
|
2023-09-30
|
ACTUAL
|
2023-09-30
|
2022-08-30
|
ACTUAL
|
2022-08-30
| null |
INTERVENTIONAL
| null |
12
|
Smith-Lemli-Opitz Syndrome and Cholic Acid
|
Smith-Lemli-Opitz Syndrome: A Pilot Study of Cholic Acid Supplementation
|
COMPLETED
| null |
PHASE1/PHASE2
| 12 |
ACTUAL
|
University of Nebraska
|
No limitations or caveats.
| 1 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null |
t
| null | null |
Data will be available one year after completion of the study. Data will be available indefinitely.
|
Data will be made available to everyone.
| null |
YES
|
All data will be de-identified and submitted to the Database of Genotypes and Phenotypes (dbGAP), according to NIH regulations.
|
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
OTHER
| null | null | null | null |
plasma
| null | 2,023 | 1 |
NCT03621761
| null |
2018-08-03
|
2022-10-03
| null |
2022-12-05
|
2018-08-03
|
2018-08-08
|
ACTUAL
|
2022-12-05
|
2022-12-27
|
ACTUAL
| null | null | null |
2022-12-05
|
2022-12-27
|
ACTUAL
|
2018-11-15
|
ACTUAL
|
2018-11-15
|
2022-12
|
2022-12-31
|
2021-11-30
|
ACTUAL
|
2021-11-30
|
2021-08-24
|
ACTUAL
|
2021-08-24
| null |
INTERVENTIONAL
|
COMBO-MS
| null |
Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue
|
A Randomized Controlled Trial of Telephone-delivered Cognitive Behavioral-therapy, Modafinil, and Combination Therapy of Both Interventions for Fatigue in Multiple Sclerosis
|
COMPLETED
| null |
PHASE4
| 343 |
ACTUAL
|
University of Michigan
| null | 3 | null | null |
f
| null | null | null |
f
|
t
|
f
| null | null |
f
| null | null | null | null | null |
NO
| null |
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
OTHER
| null | null | null | null | null | null | 2,021 | 1 |
NCT05163756
| null |
2021-12-07
| null | null |
2021-12-07
|
2021-12-07
|
2021-12-20
|
ACTUAL
| null | null | null | null | null | null |
2021-12-07
|
2021-12-20
|
ACTUAL
|
2020-11-25
|
ACTUAL
|
2020-11-25
|
2021-12
|
2021-12-31
|
2021-05-10
|
ACTUAL
|
2021-05-10
|
2021-04-27
|
ACTUAL
|
2021-04-27
| null |
INTERVENTIONAL
| null | null |
To Evaluate the Efficacy and Safety of DW1903 in Acute and Chronic Gastritis Patient
|
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1903 in Patients With Gastritis
|
COMPLETED
| null |
PHASE3
| 332 |
ACTUAL
|
Daewon Pharmaceutical Co., Ltd.
| null | 2 | null | null |
f
| null | null | null | null |
f
|
f
| null | null | null | null | null | null | null | null |
NO
|
There is no plan for IPD.
|
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
INDUSTRY
| null | null | null | null | null | null | 2,021 | 1 |
NCT05289830
| null |
2022-03-11
| null | null |
2024-06-17
|
2022-03-11
|
2022-03-21
|
ACTUAL
| null | null | null | null | null | null |
2024-06-17
|
2024-06-18
|
ACTUAL
|
2022-08-05
|
ACTUAL
|
2022-08-05
|
2024-06
|
2024-06-30
|
2023-08-27
|
ACTUAL
|
2023-08-27
|
2023-08-27
|
ACTUAL
|
2023-08-27
| null |
INTERVENTIONAL
| null | null |
Escitalopram to Placebo in Patients With Localized Pancreatic Cancer
|
A Phase II, Randomized, Double-blind, Trial Comparing Escitalopram to Placebo in Patients With Localized Pancreatic Cancer
|
TERMINATED
| null |
PHASE2
| 4 |
ACTUAL
|
Case Comprehensive Cancer Center
| null | 2 | null |
Slow accrual
|
f
| null | null | null |
t
|
t
|
f
| null | null |
f
| null | null |
4 years to publication
| null | null |
YES
|
plan to publish the results
|
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
OTHER
| null | null | null | null | null | null | 2,023 | 0 |
NCT02743611
| null |
2016-04-11
|
2023-06-08
| null |
2023-09-12
|
2016-04-18
|
2016-04-19
|
ESTIMATED
|
2023-09-12
|
2023-10-05
|
ACTUAL
| null | null | null |
2023-09-12
|
2023-10-05
|
ACTUAL
|
2017-04-14
|
ACTUAL
|
2017-04-14
|
2023-06
|
2023-06-30
|
2020-07-19
|
ACTUAL
|
2020-07-19
|
2019-07-19
|
ACTUAL
|
2019-07-19
| null |
INTERVENTIONAL
| null | null |
Safety & Activity of Controllable PRAME-TCR Therapy in Previously Treated AML/MDS or Metastatic Uveal Melanoma
|
A Phase 1/2 Dose-Finding Study to Evaluate the Safety, Feasibility, and Activity of BPX-701, a Controllable PRAME T-Cell Receptor Therapy, in HLA-A2+ Subjects With AML, Previously Treated MDS, or Metastatic Uveal Melanoma
|
TERMINATED
| null |
PHASE1/PHASE2
| 4 |
ACTUAL
|
Bellicum Pharmaceuticals
| null | 4 | null |
company decision
|
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 06:40:32.340931
|
2024-10-15 06:40:32.340931
|
INDUSTRY
| null | null | null | null | null | null | 2,020 | 0 |
NCT03635567
| null |
2018-08-15
|
2023-09-20
| null |
2024-06-12
|
2018-08-15
|
2018-08-17
|
ACTUAL
|
2023-09-20
|
2023-10-12
|
ACTUAL
| null | null | null |
2024-06-12
|
2024-06-25
|
ACTUAL
|
2018-10-25
|
ACTUAL
|
2018-10-25
|
2024-06
|
2024-06-30
|
2024-06-04
|
ACTUAL
|
2024-06-04
|
2022-10-03
|
ACTUAL
|
2022-10-03
| null |
INTERVENTIONAL
| null | null |
Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)
|
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)
|
COMPLETED
| null |
PHASE3
| 617 |
ACTUAL
|
Merck Sharp & Dohme LLC
| null | 2 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null |
http://engagezone.msd.com/ds_documentation.php
|
YES
|
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
|
2024-10-15 17:20:59.799345
|
2024-10-15 17:20:59.799345
|
INDUSTRY
| null | null | null | null | null | null | 2,024 | 1 |
NCT04411446
| null |
2020-05-26
| null | null |
2021-07-28
|
2020-05-31
|
2020-06-02
|
ACTUAL
| null | null | null | null | null | null |
2021-07-28
|
2021-07-30
|
ACTUAL
|
2020-08-11
|
ACTUAL
|
2020-08-11
|
2021-03
|
2021-03-31
|
2021-07-28
|
ACTUAL
|
2021-07-28
|
2021-07-28
|
ACTUAL
|
2021-07-28
| null |
INTERVENTIONAL
|
CARED
| null |
Cholecalciferol to Improve the Outcomes of COVID-19 Patients
|
Randomized Controlled Trial of High Dose of Vitamin D as Compared With Placebo to Prevent Complications Among COVID-19 Patients
|
COMPLETED
| null |
PHASE4
| 218 |
ACTUAL
|
Vitamin D Study Group
| null | 2 | null | null |
f
| null | null | null |
f
|
f
|
f
| null | null |
f
| null | null | null | null | null |
NO
| null |
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
NETWORK
| null | null | null | null | null | null | 2,021 | 0 |
NCT04304534
| null |
2020-03-08
|
2023-02-19
| null |
2023-04-03
|
2020-03-08
|
2020-03-11
|
ACTUAL
|
2023-04-03
|
2023-04-05
|
ACTUAL
| null | null | null |
2023-04-03
|
2023-04-05
|
ACTUAL
|
2020-06-17
|
ACTUAL
|
2020-06-17
|
2023-04
|
2023-04-30
|
2022-02-21
|
ACTUAL
|
2022-02-21
|
2022-02-21
|
ACTUAL
|
2022-02-21
| null |
INTERVENTIONAL
|
PACIFIC-AMI
|
FAS(Full data analysis)
|
Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack
|
Multicenter, Randomized, Placebo Controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate the Efficacy and Safety of BAY 2433334 in Patients Following an Acute Myocardial Infarction
|
COMPLETED
| null |
PHASE2
| 1,601 |
ACTUAL
|
Bayer
| null | 4 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
UNDECIDED
|
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access.~As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
|
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
INDUSTRY
| null | null | null | null | null | null | 2,022 | 1 |
NCT02962895
| null |
2016-11-03
| null |
2020-07-16
|
2022-01-20
|
2016-11-09
|
2016-11-15
|
ESTIMATED
| null | null | null | null | null | null |
2022-01-20
|
2022-01-24
|
ACTUAL
|
2017-06-27
|
ACTUAL
|
2017-06-27
|
2022-01
|
2022-01-31
|
2021-09-23
|
ACTUAL
|
2021-09-23
|
2020-06-30
|
ACTUAL
|
2020-06-30
| null |
INTERVENTIONAL
| null | null |
Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)
|
Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)
|
COMPLETED
| null |
PHASE2
| 192 |
ACTUAL
|
Novartis
| null | 4 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
UNDECIDED
|
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
|
2024-10-15 18:03:23.937454
|
2024-10-15 18:03:23.937454
|
INDUSTRY
| null | null | null | null | null | null | 2,021 | 1 |
NCT02918968
| null |
2016-09-27
|
2021-03-25
| null |
2021-05-18
|
2016-09-27
|
2016-09-29
|
ESTIMATED
|
2021-05-18
|
2021-05-21
|
ACTUAL
| null | null | null |
2021-05-18
|
2021-05-21
|
ACTUAL
|
2016-11-02
|
ACTUAL
|
2016-11-02
|
2021-05
|
2021-05-31
|
2020-03-27
|
ACTUAL
|
2020-03-27
|
2020-03-27
|
ACTUAL
|
2020-03-27
| null |
INTERVENTIONAL
| null |
Intent-to-Treat (ITT) population was defined as all participants randomized in this study.
|
Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer
|
A Randomized Phase IV Study Comparing Enzalutamide Versus Flutamide in Castration-resistant Prostate Cancer (CRPC) Patients Who Have Failed Combined Androgen Blockade Therapy With Bicalutamide Plus Androgen Deprivation Therapy (ADT)
|
COMPLETED
| null |
PHASE4
| 206 |
ACTUAL
|
Astellas Pharma Inc
| null | 2 | null | null |
f
| null | null | null |
f
|
t
|
f
| null | null |
t
| null | null |
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
|
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
|
https://www.clinicalstudydatarequest.com/
|
YES
|
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
|
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
INDUSTRY
| null | null | null | null | null | null | 2,020 | 1 |
NCT02175212
| null |
2014-06-23
|
2016-05-04
| null |
2020-11-03
|
2014-06-25
|
2014-06-26
|
ESTIMATED
|
2016-09-16
|
2016-11-04
|
ESTIMATED
| null | null | null |
2020-11-03
|
2020-11-20
|
ACTUAL
|
2005-11
| null |
2005-11-30
|
2020-11
|
2020-11-30
|
2020-09-24
|
ACTUAL
|
2020-09-24
|
2014-06
|
ACTUAL
|
2014-06-30
| null |
INTERVENTIONAL
|
AADLPC
| null |
Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer
|
Phase III Multicenter Randomized Trial of Adjuvant Androgen Deprivation in Combination With Three-dimensional Conformal Radiotherapy Doses in High and Intermediate Risk Localized Prostate Cancer.
|
COMPLETED
| null |
PHASE3
| 362 |
ACTUAL
|
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
|
* Relatively short follow-up and low number of events.~* The lack of patient-reported outcomes.~* Our decision to include vascular events other than strictly cardiac events (e.g. the presence of CVA or thromboembolic disease).
| 2 | null | null |
f
| null | null | null |
f
| null | null | null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
OTHER
| null | null | null | null | null | null | 2,020 | 1 |
NCT05054400
| null |
2021-09-03
| null | null |
2023-08-30
|
2021-09-21
|
2021-09-23
|
ACTUAL
| null | null | null | null | null | null |
2023-08-30
|
2023-09-01
|
ACTUAL
|
2020-02-05
|
ACTUAL
|
2020-02-05
|
2023-08
|
2023-08-31
|
2023-08-29
|
ACTUAL
|
2023-08-29
|
2023-08-29
|
ACTUAL
|
2023-08-29
| null |
INTERVENTIONAL
| null | null |
Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR
|
Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR
|
WITHDRAWN
| null |
EARLY_PHASE1
| 0 |
ACTUAL
|
M.D. Anderson Cancer Center
| null | 1 | null |
0 participant accrual
|
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
OTHER
| null | null | null | null | null | null | 2,023 | 0 |
NCT05165849
| null |
2021-12-06
| null | null |
2022-05-16
|
2021-12-16
|
2021-12-21
|
ACTUAL
| null | null | null | null | null | null |
2022-05-16
|
2022-05-20
|
ACTUAL
|
2022-04
|
ESTIMATED
|
2022-04-30
|
2022-05
|
2022-05-31
|
2022-05-11
|
ACTUAL
|
2022-05-11
|
2022-05-11
|
ACTUAL
|
2022-05-11
| null |
INTERVENTIONAL
| null | null |
A Study of GFS101A in Combination With Toripalimab in Patients With Advanced Solid Tumors
|
A Multicenter, Open-label, Phase I/Ⅱ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFS101A in Combination With Toripalimab Treating Patients With Advanced Solid Tumors
|
WITHDRAWN
| null |
PHASE1/PHASE2
| 0 |
ACTUAL
|
Genfleet Therapeutics (Shanghai) Inc.
| null | 1 | null |
sponsor decided to withdraw the study
|
f
| null | null | null | null |
f
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
INDUSTRY
| null | null | null | null | null | null | 2,022 | 0 |
NCT03393117
| null |
2017-12-26
| null | null |
2020-07-21
|
2018-01-05
|
2018-01-08
|
ACTUAL
| null | null | null | null | null | null |
2020-07-21
|
2020-07-22
|
ACTUAL
|
2018-03-30
|
ACTUAL
|
2018-03-30
|
2020-07
|
2020-07-31
|
2020-07-01
|
ESTIMATED
|
2020-07-01
|
2020-07-01
|
ESTIMATED
|
2020-07-01
| null |
INTERVENTIONAL
| null | null |
Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction
|
Prospective, Randomized, Blinded Comparison of Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Unilateral, Immediate Breast Reconstruction
|
WITHDRAWN
| null |
PHASE2
| 0 |
ACTUAL
|
Case Comprehensive Cancer Center
| null | 2 | null |
No accrual
|
f
| null | null | null |
t
|
t
|
f
| null | null |
f
| null | null | null | null | null | null | null |
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
OTHER
| null | null | null | null | null | null | 2,020 | 0 |
NCT03994146
| null |
2019-06-13
| null | null |
2023-08-18
|
2019-06-20
|
2019-06-21
|
ACTUAL
| null | null | null | null | null | null |
2023-08-18
|
2023-08-22
|
ACTUAL
|
2020-01-16
|
ACTUAL
|
2020-01-16
|
2023-08
|
2023-08-31
|
2023-08-18
|
ACTUAL
|
2023-08-18
|
2023-08-18
|
ACTUAL
|
2023-08-18
| null |
INTERVENTIONAL
| null | null |
Remifentanil Tapering and Post-adenotonsillectomy Pain in Children
|
Remifentanil Tapering and Post-adenotonsillectomy Pain in Children: a Randomised, Placebo Controlled, Double Blind Study
|
TERMINATED
| null |
PHASE4
| 6 |
ACTUAL
|
University Hospital, Akershus
| null | 2 | null |
Recruitment rate was not compatible with study completion
|
f
| null | null | null |
t
|
f
|
f
| null | null |
f
| null | null |
The data will be available following completion of the study and analysis and publication by the investigating team.~There is no plan to time limit access to the data following this.
|
On request and following consultation with the Regional Ethics Committee and the Data Protection Officer at the host institution.
| null |
YES
|
On request and following consultation with the Regional Ethics Committee and the Data Protection Officer at the host institution.
|
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
OTHER
| null | null | null | null | null | null | 2,023 | 0 |
NCT03987451
| null |
2019-06-12
|
2024-04-10
|
2022-04-19
|
2024-05-28
|
2019-06-12
|
2019-06-17
|
ACTUAL
|
2024-05-28
|
2024-05-29
|
ACTUAL
| null |
2024-05-29
|
ACTUAL
|
2024-05-28
|
2024-05-29
|
ACTUAL
|
2019-06-18
|
ACTUAL
|
2019-06-18
|
2024-05
|
2024-05-31
|
2021-06-10
|
ACTUAL
|
2021-06-10
|
2021-04-22
|
ACTUAL
|
2021-04-22
| null |
INTERVENTIONAL
| null |
Full analysis set (FAS) included all randomized participants.
|
A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage
|
Investigation of Efficacy and Safety of Semaglutide s.c. Once-weekly Versus Placebo in Subjects With Non-alcoholic Steatohepatitis and Compensated Liver Cirrhosis
|
COMPLETED
| null |
PHASE2
| 71 |
ACTUAL
|
Novo Nordisk A/S
| null | 2 | null | null |
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null | null | null |
http://novonordisk-trials.com
|
YES
|
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
|
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
INDUSTRY
| null | null | null | null | null | null | 2,021 | 1 |
NCT02987543
| null |
2016-11-15
|
2020-06-03
| null |
2023-10-04
|
2016-12-06
|
2016-12-09
|
ESTIMATED
|
2020-09-18
|
2020-10-12
|
ACTUAL
| null | null | null |
2023-10-04
|
2023-10-06
|
ACTUAL
|
2017-02-06
|
ACTUAL
|
2017-02-06
|
2023-09
|
2023-09-30
|
2023-02-15
|
ACTUAL
|
2023-02-15
|
2019-06-04
|
ACTUAL
|
2019-06-04
| null |
INTERVENTIONAL
| null | null |
Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)
|
A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)
|
COMPLETED
| null |
PHASE3
| 387 |
ACTUAL
|
AstraZeneca
| null | 2 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
INDUSTRY
| null | null | null | null | null | null | 2,023 | 1 |
NCT03061474
| null |
2017-02-13
|
2023-08-22
| null |
2023-09-22
|
2017-02-17
|
2017-02-23
|
ACTUAL
|
2023-09-22
|
2023-10-17
|
ACTUAL
| null | null | null |
2023-09-22
|
2023-10-17
|
ACTUAL
|
2017-07-12
|
ACTUAL
|
2017-07-12
|
2023-09
|
2023-09-30
|
2022-08-30
|
ACTUAL
|
2022-08-30
|
2022-08-30
|
ACTUAL
|
2022-08-30
| null |
INTERVENTIONAL
|
NEAT
| null |
Nicotinamide as an Early Alzheimer's Disease Treatment
|
A Double-Blind-Randomized, Placebo-Controlled Adaptive Design Trial of Nicotinamide in Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease Dementia
|
COMPLETED
| null |
PHASE2
| 46 |
ACTUAL
|
University of California, Irvine
| null | 2 | null | null | null | null | null | null |
t
|
t
|
f
| null | null | null | null | null |
6 months after publication
|
Data requestors must complete ADCS data and sample sharing request form. Upon approval, requestors must complete a data use agreement prior to accessing data.
|
https://www.adcs.org/data-sharing
|
YES
|
Data sharing is integral to the ADCS's mission to develop and execute innovative clinical trials focused on interventions that may prevent, delay, or treat the expression of Alzheimer's disease and related dementias. The ADCS is committed to sharing resources and tools, including data, biospecimens, trial designs, outcome and analysis measures following NIH guidelines.~DATA Sharing: The ADCS Data and Sample Sharing Committee (DSSC) grants access to de-identified data to individuals who complete the request process and agree to the conditions in an ADCS/UCSD Data Us Agreement (DUA). After approval and receipt of the fully executed DUA, applicants are authorized to acquire data. Non-compliance with the DUA, including the requirement to provide requested updates will jeopardize further access to data.
|
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
OTHER
| null | null | null | null | null | null | 2,022 | 1 |
NCT03121963
| null |
2017-04-17
| null | null |
2021-06-17
|
2017-04-17
|
2017-04-20
|
ACTUAL
| null | null | null | null | null | null |
2021-06-17
|
2021-06-22
|
ACTUAL
|
2017-11-10
|
ACTUAL
|
2017-11-10
|
2021-06
|
2021-06-30
|
2021-11-06
|
ESTIMATED
|
2021-11-06
|
2020-11-06
|
ACTUAL
|
2020-11-06
| null |
INTERVENTIONAL
| null | null |
Pain Management in Head and Neck Surgery Patients
|
Pain Management in Head and Neck Surgery Patients
|
WITHDRAWN
| null |
PHASE4
| 0 |
ACTUAL
|
University of Alabama at Birmingham
| null | 2 | null |
This protocol was difficult to enroll into, and changes to personnel have made it difficult to main this study. Data collection was not completed and therefore, no data analysis was performed. The PI has made the decision to close this study.
|
f
| null | null | null |
f
|
t
|
f
| null | null |
f
| null | null | null | null | null |
NO
|
There is no current plan to share individual participant data for this protocol.
|
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
OTHER
| null | null | null | null | null | null | 2,021 | 0 |
NCT03038399
| null |
2017-01-30
|
2021-04-28
| null |
2021-04-28
|
2017-01-30
|
2017-01-31
|
ESTIMATED
|
2021-04-28
|
2021-05-20
|
ACTUAL
| null | null | null |
2021-04-28
|
2021-05-20
|
ACTUAL
|
2017-02-02
|
ACTUAL
|
2017-02-02
|
2021-04
|
2021-04-30
|
2020-04-30
|
ACTUAL
|
2020-04-30
|
2020-04-30
|
ACTUAL
|
2020-04-30
| null |
INTERVENTIONAL
| null |
Subjects entered this study in one of 4 dose level groups, but were allowed to escalate/de-escalate during the course of the study.
|
Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
|
A 24-month Phase II Open-label, Multicenter Long-term Extension Study to Assess the Long-Term Safety and Efficacy of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
|
COMPLETED
| null |
PHASE2
| 46 |
ACTUAL
|
ReveraGen BioPharma, Inc.
| null | 4 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
INDUSTRY
| null | null | null | null | null | null | 2,020 | 1 |
NCT03639324
| null |
2018-08-08
| null | null |
2021-11-01
|
2018-08-16
|
2018-08-21
|
ACTUAL
| null | null | null | null | null | null |
2021-11-01
|
2021-11-09
|
ACTUAL
|
2020-10-02
|
ACTUAL
|
2020-10-02
|
2021-11
|
2021-11-30
|
2021-10-18
|
ACTUAL
|
2021-10-18
|
2021-10-18
|
ACTUAL
|
2021-10-18
| null |
INTERVENTIONAL
|
RIVe-CLL/SLL
| null |
Rituximab, Idelalisib, and Venetoclax in Relapsed/Refractory CLL/SLL
|
Phase 1 Trial of Rituximab, Idelalisib, and Venetoclax in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (RIVe-CLL/SLL)
|
WITHDRAWN
| null |
PHASE1
| 0 |
ACTUAL
|
Virginia Commonwealth University
| null | 6 | null |
Slow Accrual
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:27:29.412593
|
2024-10-15 17:27:29.412593
|
OTHER
| null | null | null | null | null | null | 2,021 | 0 |
NCT04484935
| null |
2020-06-30
|
2023-08-29
| null |
2023-10-25
|
2020-07-20
|
2020-07-24
|
ACTUAL
|
2023-10-25
|
2023-11-15
|
ACTUAL
| null | null | null |
2023-10-25
|
2023-11-15
|
ACTUAL
|
2020-08-19
|
ACTUAL
|
2020-08-19
|
2023-10
|
2023-10-31
|
2023-02-17
|
ACTUAL
|
2023-02-17
|
2023-02-17
|
ACTUAL
|
2023-02-17
| null |
INTERVENTIONAL
|
MUSIC
|
The As-treated population consisted of all participants who were enrolled and received any dose of nirsevimab.
|
Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children
|
A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children ≤ 24 Months of Age
|
COMPLETED
| null |
PHASE2
| 100 |
ACTUAL
|
AstraZeneca
| null | 1 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null |
AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
|
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
|
https://astrazenecagroup-dt.pharmacm.com/DT/Home
|
YES
|
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.~All request will be evaluated as per the AstraZeneca (AZ) disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AstraZeneca (AZ) are accepting requests for Individual Participant Data (IPD), but this does not mean all requests will be shared.
|
2024-10-15 18:03:23.937454
|
2024-10-15 18:03:23.937454
|
INDUSTRY
| null | null | null | null | null | null | 2,023 | 1 |
NCT04746131
| null |
2021-02-04
| null | null |
2022-09-22
|
2021-02-04
|
2021-02-09
|
ACTUAL
| null | null | null | null | null | null |
2022-09-22
|
2022-09-26
|
ACTUAL
|
2021-01-15
|
ACTUAL
|
2021-01-15
|
2022-04
|
2022-04-30
|
2024-04-11
|
ESTIMATED
|
2024-04-11
|
2024-04-11
|
ESTIMATED
|
2024-04-11
| null |
INTERVENTIONAL
| null | null |
Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
|
Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
|
SUSPENDED
| null |
PHASE1
| 90 |
ESTIMATED
|
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
| null | 1 | null |
Due to the product development strategy change, without any safety concerns, we (the sponsor of the trial) have decided to request to place the IND (#151570) on inactive status.
|
f
| null | null | null | null |
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 18:03:23.937454
|
2024-10-15 18:03:23.937454
|
OTHER
| null | null | null | null | null | null | 2,024 | 0 |
NCT03068468
| null |
2017-02-27
|
2020-09-03
| null |
2020-11-25
|
2017-02-27
|
2017-03-01
|
ACTUAL
|
2020-11-25
|
2020-12-21
|
ACTUAL
| null | null | null |
2020-11-25
|
2020-12-21
|
ACTUAL
|
2017-06-01
|
ACTUAL
|
2017-06-01
|
2020-11
|
2020-11-30
|
2020-02-07
|
ACTUAL
|
2020-02-07
|
2019-09-06
|
ACTUAL
|
2019-09-06
| null |
INTERVENTIONAL
|
PASSPORT
|
Intent-to-treat (ITT) population included randomized participants who had received at least 1 dose of blinded study treatment (BIIB092 or Placebo).
|
Study of BIIB092 in Participants With Progressive Supranuclear Palsy
|
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants With Progressive Supranuclear Palsy
|
TERMINATED
| null |
PHASE2
| 490 |
ACTUAL
|
Biogen
|
Study got terminated as the primary endpoint was not met. PC period was completed at the time of termination. The study was not terminated due to a safety concern.
| 2 | null |
251PP301(PASSPORT) primary endpoint was not met;Biogen decision to close the study early. There were no safety concerns with the PASSPORT study.
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
INDUSTRY
| null | null | null | null | null | null | 2,020 | 0 |
NCT04731051
| null |
2021-01-28
| null | null |
2023-04-05
|
2021-01-28
|
2021-01-29
|
ACTUAL
| null | null | null | null | null | null |
2023-04-05
|
2023-04-07
|
ACTUAL
|
2022-10
|
ESTIMATED
|
2022-10-31
|
2023-04
|
2023-04-30
|
2022-12
|
ESTIMATED
|
2022-12-31
|
2022-11
|
ESTIMATED
|
2022-11-30
| null |
INTERVENTIONAL
| null | null |
The Potential Use of Inhaled Hydroxychloroquine for the Treatment of COVID-19 in Cancer Patients
|
A Pilot, Randomized, Open-label Trial to Determine the Feasibility, Safety, Efficacy, and Pharmacokinetics of Nebulized HCQ01 for the Treatment of Patients With COVID-19 and Cancer
|
WITHDRAWN
| null |
PHASE1/PHASE2
| 0 |
ACTUAL
|
King Hussein Cancer Center
| null | 2 | null |
the study was terminated as no more COVID cases were treated at the center
|
f
| null | null | null |
f
|
f
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
OTHER
| null | null | null | null | null | null | 2,022 | 0 |
NCT04658849
| null |
2020-10-27
| null | null |
2023-05-11
|
2020-12-07
|
2020-12-09
|
ACTUAL
| null | null | null | null | null | null |
2023-05-11
|
2023-05-15
|
ACTUAL
|
2020-12-02
|
ACTUAL
|
2020-12-02
|
2023-05
|
2023-05-31
|
2023-03-29
|
ACTUAL
|
2023-03-29
|
2023-03-29
|
ACTUAL
|
2023-03-29
| null |
INTERVENTIONAL
| null | null |
Insulin Resistance Following ADT for Prostate CA
|
Insulin Resistance Following Androgen Deprivation Therapy in Men With Prostate Cancer
|
WITHDRAWN
| null |
EARLY_PHASE1
| 0 |
ACTUAL
|
St. Louis University
| null | 2 | null |
End of grant funding
|
f
| null | null | null |
f
|
t
|
f
| null | null |
t
| null | null | null | null | null |
NO
| null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
OTHER
| null | null | null | null | null | null | 2,023 | 0 |
NCT05629364
| null |
2022-11-17
| null | null |
2024-01-09
|
2022-11-17
|
2022-11-29
|
ACTUAL
| null | null | null | null | null | null |
2024-01-09
|
2024-01-10
|
ACTUAL
|
2023-03-15
|
ACTUAL
|
2023-03-15
|
2024-01
|
2024-01-31
|
2024-01-09
|
ACTUAL
|
2024-01-09
|
2024-01-09
|
ACTUAL
|
2024-01-09
| null |
INTERVENTIONAL
| null | null |
A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease
|
A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease
|
TERMINATED
| null |
PHASE2
| 4 |
ACTUAL
|
Kiora Pharmaceuticals, Inc.
| null | 3 | null |
Study halted prematurely but potentially will resume
|
f
| null | null | null |
f
|
f
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
INDUSTRY
| null | null | null | null | null | null | 2,024 | 0 |
NCT04246619
| null |
2020-01-24
| null | null |
2022-03-29
|
2020-01-28
|
2020-01-29
|
ACTUAL
| null | null | null | null | null | null |
2022-03-29
|
2022-04-07
|
ACTUAL
|
2019-11-12
|
ACTUAL
|
2019-11-12
|
2022-03
|
2022-03-31
|
2021-12-21
|
ACTUAL
|
2021-12-21
|
2021-12-21
|
ACTUAL
|
2021-12-21
| null |
INTERVENTIONAL
|
BLOSSOM
| null |
Efficacy of Pregabalin and Duloxetine in Patients With PDPN: the Effect of Pain on Cognitive Function, Sleep and Quality of Life
|
Efficacy of Pregabalin and Duloxetine in Patients With Painful Diabetic Peripheral Neuropathy (PDPN): the Effect of Pain on Cognitive Function, Sleep and Quality of Life (BLOSSOM)
|
TERMINATED
| null |
PHASE4
| 254 |
ACTUAL
|
KRKA
| null | 2 | null |
The statistical analysis will still provide relevant results with the same statistical power as initially planned.COVID-19 pandemic prolonged the recruiting period and consequently affected the costs of the clinical trial.
|
f
| null | null | null |
f
|
f
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
INDUSTRY
| null | null | null | null | null | null | 2,021 | 0 |
NCT00995150
| null |
2009-10-13
|
2023-10-31
|
2022-08-04
|
2024-07-22
|
2009-10-14
|
2009-10-15
|
ESTIMATED
|
2024-07-22
|
2024-08-14
|
ACTUAL
|
2022-08-04
|
2022-08-09
|
ACTUAL
|
2024-07-22
|
2024-08-14
|
ACTUAL
|
2009-11
|
ACTUAL
|
2009-11-30
|
2024-07
|
2024-07-31
|
2021-10-12
|
ACTUAL
|
2021-10-12
|
2021-10-12
|
ACTUAL
|
2021-10-12
| null |
INTERVENTIONAL
| null | null |
A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
|
A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
|
TERMINATED
| null |
PHASE3
| 1,910 |
ACTUAL
|
Medicines360
| null | 3 | null |
The data cutoff date of 05 April 2021 was chosen as it coincides with all subjects completing through Year 8 of use (intended duration of use for the product).
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
OTHER
| null | null | null | null | null | null | 2,021 | 0 |
NCT04347135
| null |
2020-04-13
| null | null |
2024-05-08
|
2020-04-13
|
2020-04-15
|
ACTUAL
| null | null | null | null | null | null |
2024-05-08
|
2024-05-10
|
ACTUAL
|
2022-10-07
|
ACTUAL
|
2022-10-07
|
2024-04
|
2024-04-30
|
2024-04-30
|
ACTUAL
|
2024-04-30
|
2024-04-30
|
ACTUAL
|
2024-04-30
| null |
INTERVENTIONAL
| null | null |
Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI
|
Pilot Study Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI
|
WITHDRAWN
| null |
PHASE1/PHASE2
| 0 |
ACTUAL
|
Mayo Clinic
| null | 1 | null |
No Enrollment
|
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
OTHER
| null | null | null | null | null | null | 2,024 | 0 |
NCT03795428
| null |
2018-12-18
| null | null |
2022-02-04
|
2019-01-04
|
2019-01-07
|
ACTUAL
| null | null | null | null | null | null |
2022-02-04
|
2022-02-22
|
ACTUAL
|
2019-04-10
|
ACTUAL
|
2019-04-10
|
2022-02
|
2022-02-28
|
2022-01-11
|
ACTUAL
|
2022-01-11
|
2022-01-11
|
ACTUAL
|
2022-01-11
| null |
INTERVENTIONAL
|
VIP Extend
| null |
Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004
|
A Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) Subcutaneous Injections in Pulmonary Arterial Hypertension Subjects Following Completion of Study PB1046-PT-CL-0004
|
TERMINATED
| null |
PHASE2
| 25 |
ACTUAL
|
PhaseBio Pharmaceuticals Inc.
| null | 1 | null |
Terminated: Study drug resupply delayed (Covid-19)
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
INDUSTRY
| null | null | null | null | null | null | 2,022 | 0 |
NCT05193318
| null |
2021-12-14
|
2024-03-13
| null |
2024-04-10
|
2021-12-30
|
2022-01-14
|
ACTUAL
|
2024-04-10
|
2024-05-06
|
ACTUAL
| null | null | null |
2024-04-10
|
2024-05-06
|
ACTUAL
|
2022-01-13
|
ACTUAL
|
2022-01-13
|
2024-04
|
2024-04-30
|
2023-03-20
|
ACTUAL
|
2023-03-20
|
2023-03-20
|
ACTUAL
|
2023-03-20
| null |
INTERVENTIONAL
|
KReDO
| null |
KAP for Depression in Abstinent Opioid Users
|
Ketamine-assisted Psychotherapy for the Treatment of Persistent Depression in Abstinent Opioid Users
|
TERMINATED
| null |
PHASE2
| 5 |
ACTUAL
|
Medical University of South Carolina
| null | 1 | null |
Primary Investigator leaving institution
|
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
OTHER
| null | null | null | null | null | null | 2,023 | 0 |
NCT03052361
| null |
2017-02-07
| null | null |
2020-10-19
|
2017-02-09
|
2017-02-14
|
ACTUAL
| null | null | null | null | null | null |
2020-10-19
|
2020-10-22
|
ACTUAL
|
2017-07-15
|
ACTUAL
|
2017-07-15
|
2020-10
|
2020-10-31
|
2020-10-03
|
ACTUAL
|
2020-10-03
|
2020-09-03
|
ACTUAL
|
2020-09-03
| null |
INTERVENTIONAL
| null | null |
Triage Administration of Ondansetron for Gastroenteritis in Children
|
Triage Administration of Ondansetron for Gastroenteritis in Children; a Randomized Controlled Trial
|
TERMINATED
| null |
PHASE2/PHASE3
| 81 |
ACTUAL
|
St. Justine's Hospital
| null | 2 | null |
The recruitment was much slower than expected and the COVID pandemic added new barriers to recruitment.
|
f
| null | null | null |
f
|
f
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
OTHER
| null | null | null | null | null | null | 2,020 | 0 |
NCT05136443
| null |
2021-10-29
|
2024-07-23
| null |
2024-07-23
|
2021-11-17
|
2021-11-29
|
ACTUAL
|
2024-07-23
|
2024-08-14
|
ACTUAL
| null | null | null |
2024-07-23
|
2024-08-14
|
ACTUAL
|
2021-11-23
|
ACTUAL
|
2021-11-23
|
2023-09
|
2023-09-30
|
2023-09-05
|
ACTUAL
|
2023-09-05
|
2023-09-05
|
ACTUAL
|
2023-09-05
| null |
INTERVENTIONAL
| null | null |
Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection
|
Prospective Analysis of Loteprednol Etabonate Ophthalmic Suspension 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty
|
COMPLETED
| null |
PHASE4
| 70 |
ACTUAL
|
Price Vision Group
| null | 1 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null |
f
| null | null | null | null | null |
NO
| null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
INDUSTRY
| null | null | null | null | null | null | 2,023 | 1 |
NCT03398837
| null |
2018-01-05
| null | null |
2021-03-25
|
2018-01-11
|
2018-01-16
|
ACTUAL
| null | null | null | null | null | null |
2021-03-25
|
2021-03-29
|
ACTUAL
|
2017-12-18
|
ACTUAL
|
2017-12-18
|
2021-03
|
2021-03-31
|
2020-12-21
|
ACTUAL
|
2020-12-21
|
2020-05-27
|
ACTUAL
|
2020-05-27
| null |
INTERVENTIONAL
|
RESOLVE-1
| null |
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
|
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
|
TERMINATED
| null |
PHASE3
| 365 |
ACTUAL
|
Corbus Pharmaceuticals Inc.
| null | 3 | null |
Sponsor terminated open-label extension
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
UNDECIDED
| null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
INDUSTRY
| null | null | null | null | null | null | 2,020 | 0 |
NCT02002819
| null |
2013-10-25
|
2021-10-04
| null |
2022-04-22
|
2013-12-02
|
2013-12-06
|
ESTIMATED
|
2022-04-22
|
2022-05-16
|
ACTUAL
| null | null | null |
2022-04-22
|
2022-05-16
|
ACTUAL
|
2014-10-16
|
ACTUAL
|
2014-10-16
|
2022-04
|
2022-04-30
|
2020-07-21
|
ACTUAL
|
2020-07-21
|
2020-07-21
|
ACTUAL
|
2020-07-21
| null |
INTERVENTIONAL
|
LEV-AD
| null |
Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability
|
Phase 2a Levetiracetam Trial for AD-Associated Network Hyperexcitability
|
COMPLETED
| null |
PHASE2
| 34 |
ACTUAL
|
University of Minnesota
| null | 2 | null | null |
f
| null | null | null |
f
| null | null | null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
OTHER
| null | null | null | null | null | null | 2,020 | 1 |
NCT04572217
| null |
2020-09-25
| null | null |
2022-05-19
|
2020-09-25
|
2020-10-01
|
ACTUAL
| null | null | null | null | null | null |
2022-05-19
|
2022-05-26
|
ACTUAL
|
2022-06
|
ESTIMATED
|
2022-06-30
|
2022-05
|
2022-05-31
|
2022-06
|
ESTIMATED
|
2022-06-30
|
2022-06
|
ESTIMATED
|
2022-06-30
| null |
INTERVENTIONAL
|
MAABS Protocol
| null |
Medications After Adolescent Bariatric Surgery
|
Medications After Adolescent Bariatric Surgery Protocol for Inadequate Weight Loss Following Sleeve Gastrectomy in Adolescents and Young Adults: A Pilot Feasibility Study
|
WITHDRAWN
| null |
PHASE2
| 0 |
ACTUAL
|
Stanford University
| null | 2 | null |
No available funding
|
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
OTHER
| null | null | null | null | null | null | 2,022 | 0 |
NCT04361253
| null |
2020-04-23
| null | null |
2021-08-09
|
2020-04-23
|
2020-04-24
|
ACTUAL
| null | null | null | null | null | null |
2021-08-09
|
2021-08-13
|
ACTUAL
|
2020-04-30
|
ACTUAL
|
2020-04-30
|
2021-08
|
2021-08-31
|
2021-06-30
|
ACTUAL
|
2021-06-30
|
2021-04-01
|
ACTUAL
|
2021-04-01
| null |
INTERVENTIONAL
|
(ESCAPE)
| null |
Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy
|
A Prospective, Randomized, Double-Masked, Placebo-Controlled Trial of High-Titer COVID-19 Convalescent Plasma (HT-CCP) for the Treatment of Hospitalized Patients With COVID-19 of Moderate Severity
|
TERMINATED
| null |
PHASE3
| 45 |
ACTUAL
|
Brigham and Women's Hospital
| null | 2 | null |
Futility
|
f
| null | null | null | null |
t
|
f
| null | null |
f
| null | null |
Beginning 3 months after study publication. No end date.
|
Proposals should be submitted to rmkaufman@bwh.harvard.edu.
| null |
YES
|
Deidentified data will be made available upon request to the principal investigator following the publication of the primary manuscript.
|
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
OTHER
| null | null | null | null | null | null | 2,021 | 0 |
NCT04990219
| null |
2021-07-29
| null | null |
2023-02-01
|
2021-07-29
|
2021-08-04
|
ACTUAL
| null | null | null | null | null | null |
2023-02-01
|
2023-02-03
|
ACTUAL
|
2021-09-27
|
ACTUAL
|
2021-09-27
|
2023-01
|
2023-01-31
|
2023-01-31
|
ACTUAL
|
2023-01-31
|
2023-01-19
|
ACTUAL
|
2023-01-19
| null |
INTERVENTIONAL
| null | null |
A Study of Lu AG06466 for the Treatment of Spasticity in Participants With Multiple Sclerosis
|
Interventional, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 1B Study Investigating the Effects of Lu AG06466 for the Treatment of Spasticity in Patients With Multiple Sclerosis
|
TERMINATED
| null |
PHASE1
| 37 |
ACTUAL
|
H. Lundbeck A/S
| null | 2 | null |
The study was terminated for strategic reasons
|
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:33:07.36542
|
2024-10-15 17:33:07.36542
|
INDUSTRY
| null | null | null | null | null | null | 2,023 | 0 |
NCT00487305
| null |
2007-06-15
| null | null |
2024-08-13
|
2007-06-15
|
2007-06-18
|
ESTIMATED
| null | null | null | null | null | null |
2024-08-13
|
2024-08-15
|
ACTUAL
|
2007-06
|
ACTUAL
|
2007-06-30
|
2024-08
|
2024-08-31
|
2023-07-25
|
ACTUAL
|
2023-07-25
|
2023-07-25
|
ACTUAL
|
2023-07-25
| null |
INTERVENTIONAL
| null | null |
Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma
|
A Phase I Trial of Vaccination With Lethally Irradiated Lymphoma Cells Admixed With Granulocyte-Macrophage Colony Stimulating Factor Secreting K562 Cells for the Treatment of Previously Untreated or Relapses Follicular Lymphoma
|
COMPLETED
| null |
PHASE1
| 24 |
ACTUAL
|
Dana-Farber Cancer Institute
| null | 1 | null | null |
f
| null | null | null |
t
| null | null | null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
OTHER
| null | null | null | null | null | null | 2,023 | 0 |
NCT02403323
| null |
2015-03-26
| null | null |
2023-10-30
|
2015-03-26
|
2015-03-31
|
ESTIMATED
| null | null | null | null | null | null |
2023-10-30
|
2023-11-01
|
ACTUAL
|
2015-06-08
|
ACTUAL
|
2015-06-08
|
2023-10
|
2023-10-31
|
2023-10-09
|
ACTUAL
|
2023-10-09
|
2023-10-09
|
ACTUAL
|
2023-10-09
| null |
INTERVENTIONAL
|
JUNIPER
| null |
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
|
An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144
|
TERMINATED
| null |
PHASE3
| 900 |
ESTIMATED
|
Hoffmann-La Roche
| null | 2 | null |
The study was terminated due to program discontinuation, based on mixed efficacy results in the parent studies. There were no safety concerns.
|
f
| null | null | null | null | null | null | null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
INDUSTRY
| null | null | null | null | null | null | 2,023 | 0 |
NCT05664100
| null |
2022-12-13
| null | null |
2023-04-25
|
2022-12-21
|
2022-12-23
|
ACTUAL
| null | null | null | null | null | null |
2023-04-25
|
2023-04-27
|
ACTUAL
|
2022-12-15
|
ACTUAL
|
2022-12-15
|
2023-04
|
2023-04-30
|
2023-04-12
|
ACTUAL
|
2023-04-12
|
2023-04-12
|
ACTUAL
|
2023-04-12
| null |
INTERVENTIONAL
| null | null |
First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
|
A Phase 1b, Prospective, Randomized, Single-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety of FX-345 Administered as a Single Intratympanic Injection in Adults With Acquired Adult-Onset Sensorineural Hearing Loss
|
TERMINATED
| null |
PHASE1
| 6 |
ACTUAL
|
Frequency Therapeutics
| null | 4 | null |
Business reasons
|
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
INDUSTRY
| null | null | null | null | null | null | 2,023 | 0 |
NCT04465734
| null |
2020-07-07
| null | null |
2022-05-01
|
2020-07-09
|
2020-07-10
|
ACTUAL
| null | null | null | null | null | null |
2022-05-01
|
2022-05-05
|
ACTUAL
|
2022-11-15
|
ESTIMATED
|
2022-11-15
|
2021-07
|
2021-07-31
|
2024-03-15
|
ESTIMATED
|
2024-03-15
|
2023-10-15
|
ESTIMATED
|
2023-10-15
| null |
INTERVENTIONAL
| null | null |
A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC
|
A Randomized, Open-Label, Controlled, Multicenter, Phase III Clinical Study to Compare the Efficacy and Safety of HLX10 (Anti-PD-1 Antibody) in Combination With HLX04 (Anti-VEGF Antibody) Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)
|
WITHDRAWN
| null |
PHASE3
| 0 |
ACTUAL
|
Shanghai Henlius Biotech
| null | 2 | null |
The trial used sorafenib as a control drug. It's not suitable now(after the A+T has been approved).The sponsor terminated the trial.
|
f
| null | null | null |
t
|
f
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
INDUSTRY
| null | null | null | null | null | null | 2,024 | 0 |
NCT03478956
| null |
2018-03-26
|
2020-05-19
| null |
2023-11-01
|
2018-03-26
|
2018-03-27
|
ACTUAL
|
2020-07-21
|
2020-08-05
|
ACTUAL
| null | null | null |
2023-11-01
|
2023-12-01
|
ACTUAL
|
2018-03-27
|
ACTUAL
|
2018-03-27
|
2023-11
|
2023-11-30
|
2023-09-27
|
ACTUAL
|
2023-09-27
|
2019-12-02
|
ACTUAL
|
2019-12-02
| null |
INTERVENTIONAL
|
FENNEL
| null |
A Phase I Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease
|
A Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease
|
TERMINATED
| null |
PHASE1
| 24 |
ACTUAL
|
Hoffmann-La Roche
| null | 2 | null |
The study was terminated due to program discontinuation, based on mixed efficacy results in the adult ulcerative colitis and Crohn's disease studies. There were no safety concerns.
|
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
INDUSTRY
| null | null | null | null | null | null | 2,023 | 0 |
NCT03743246
| null |
2018-10-18
|
2024-07-22
| null |
2024-07-22
|
2018-11-13
|
2018-11-16
|
ACTUAL
|
2024-07-22
|
2024-08-15
|
ACTUAL
| null | null | null |
2024-07-22
|
2024-08-15
|
ACTUAL
|
2018-10-17
|
ACTUAL
|
2018-10-17
|
2024-07
|
2024-07-31
|
2024-01-26
|
ACTUAL
|
2024-01-26
|
2024-01-26
|
ACTUAL
|
2024-01-26
| null |
INTERVENTIONAL
| null | null |
A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)
|
A Phase 1/2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL).
|
TERMINATED
| null |
PHASE1/PHASE2
| 21 |
ACTUAL
|
Celgene
|
The study was terminated and hence participants were not enrolled in Phase 2 cohorts (r/r B-ALL; MRD+ B-ALL; r/r B-NHL).
| 1 | null |
Absence of significant therapeutic benefit over existing therapies
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
INDUSTRY
| null | null | null | null | null | null | 2,024 | 0 |
NCT03749590
| null |
2018-11-12
| null | null |
2021-04-28
|
2018-11-20
|
2018-11-21
|
ACTUAL
| null | null | null | null | null | null |
2021-04-28
|
2021-05-03
|
ACTUAL
|
2012-08-27
|
ACTUAL
|
2012-08-27
|
2021-04
|
2021-04-30
|
2020-08-31
|
ACTUAL
|
2020-08-31
|
2020-07
|
ACTUAL
|
2020-07-31
| null |
INTERVENTIONAL
|
MagPEP
| null |
Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
|
Prospective Randomized Controlled Phase III Trial to Investigate the Efficacy of Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
|
TERMINATED
| null |
PHASE3
| 327 |
ACTUAL
|
University Medicine Greifswald
| null | 2 | null |
The design of the MagPEP trial is no longer in compliance with the current state of science.
|
f
| null | null | null | null |
f
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
OTHER
| null | null | null | null | null | null | 2,020 | 0 |
NCT03417492
| null |
2017-10-11
| null | null |
2022-09-16
|
2018-01-24
|
2018-01-31
|
ACTUAL
| null | null | null | null | null | null |
2022-09-16
|
2022-09-21
|
ACTUAL
|
2018-03-01
|
ACTUAL
|
2018-03-01
|
2022-09
|
2022-09-30
|
2022-06-30
|
ACTUAL
|
2022-06-30
|
2022-06-30
|
ACTUAL
|
2022-06-30
| null |
INTERVENTIONAL
| null | null |
Cerebrovascular Reactivity in American Football Players
|
Cerebrovascular Reactivity Assessed With Functional Near-infrared Spectroscopy and Magnetic Resonance Imaging as a Biomarker of Traumatic Microvascular Injury in American Football Players
|
TERMINATED
| null |
PHASE1
| 7 |
ACTUAL
|
University of Pennsylvania
| null | 1 | null |
Difficulty enrolling participants due to COVID emergency, and planned start of new study to address this question in a more rigorous fashion.
|
f
| null | null | null |
f
|
t
|
f
| null | null |
f
| null | null | null | null | null | null | null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
OTHER
| null | null | null | null | null | null | 2,022 | 0 |
NCT03582618
| null |
2018-05-21
| null | null |
2023-01-06
|
2018-07-09
|
2018-07-11
|
ACTUAL
| null | null | null | null | null | null |
2023-01-06
|
2023-01-10
|
ACTUAL
|
2018-07-12
|
ACTUAL
|
2018-07-12
|
2023-01
|
2023-01-31
|
2022-12-30
|
ACTUAL
|
2022-12-30
|
2021-11-16
|
ACTUAL
|
2021-11-16
| null |
INTERVENTIONAL
| null | null |
CVM-1118 and Sorafenib Combination in Subjects With Advanced Hepatocellular Carcinoma
|
A Phase 2, Open-Label Study With Orally Administered CVM-1118 and Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
|
TERMINATED
| null |
PHASE2
| 12 |
ACTUAL
|
TaiRx, Inc.
| null | 1 | null |
The study has been terminated due to slow enrollment
|
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
INDUSTRY
| null | null | null | null | null | null | 2,022 | 0 |
NCT02263508
| null |
2014-09-26
|
2022-03-08
| null |
2022-11-10
|
2014-10-09
|
2014-10-13
|
ESTIMATED
|
2022-04-22
|
2022-05-16
|
ACTUAL
| null | null | null |
2022-11-10
|
2022-11-14
|
ACTUAL
|
2014-12-08
|
ACTUAL
|
2014-12-08
|
2022-11
|
2022-11-30
|
2021-03-11
|
ACTUAL
|
2021-03-11
|
2021-03-11
|
ACTUAL
|
2021-03-11
| null |
INTERVENTIONAL
|
MASTERKEY-265
|
All enrolled participants
|
Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma
|
A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)
|
TERMINATED
| null |
PHASE3
| 713 |
ACTUAL
|
Amgen
| null | 3 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null |
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
|
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
|
https://www.amgen.com/datasharing
|
YES
|
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
|
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
INDUSTRY
| null | null | null | null | null | null | 2,021 | 0 |
NCT03011645
| null |
2017-01-04
| null | null |
2020-02-13
|
2017-01-04
|
2017-01-05
|
ESTIMATED
| null | null | null | null | null | null |
2020-02-13
|
2020-02-17
|
ACTUAL
|
2018-05-24
|
ACTUAL
|
2018-05-24
|
2020-02
|
2020-02-29
|
2020-01-28
|
ACTUAL
|
2020-01-28
|
2020-01-28
|
ACTUAL
|
2020-01-28
| null |
INTERVENTIONAL
| null | null |
Gene-by-Stress Interactions in Intervention Studies Significance
|
Gene-by-Stress Interactions in Intervention Studies Significance
|
TERMINATED
| null |
PHASE1
| 7 |
ACTUAL
|
Duke University
| null | 3 | null |
Lack of participants
|
f
| null | null | null |
f
|
t
|
f
| null | null |
f
| null | null | null | null | null |
NO
| null |
2024-10-16 05:34:40.88875
|
2024-10-16 05:34:40.88875
|
OTHER
| null | null | null | null | null | null | 2,020 | 0 |
NCT03663166
| null |
2018-09-06
|
2022-10-21
| null |
2023-02-14
|
2018-09-06
|
2018-09-10
|
ACTUAL
|
2023-02-14
|
2023-02-15
|
ACTUAL
| null | null | null |
2023-02-14
|
2023-02-15
|
ACTUAL
|
2018-11-20
|
ACTUAL
|
2018-11-20
|
2023-02
|
2023-02-28
|
2021-10-22
|
ACTUAL
|
2021-10-22
|
2021-10-22
|
ACTUAL
|
2021-10-22
| null |
INTERVENTIONAL
| null | null |
Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)
|
Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable NSCLC
|
TERMINATED
| null |
PHASE1/PHASE2
| 19 |
ACTUAL
|
H. Lee Moffitt Cancer Center and Research Institute
| null | 2 | null |
Increased SAE occurrence per PI
| null | null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-16 05:34:40.88875
|
2024-10-16 05:34:40.88875
|
OTHER
| null | null | null | null | null | null | 2,021 | 0 |
NCT04201743
| null |
2019-12-08
| null | null |
2020-09-30
|
2019-12-14
|
2019-12-17
|
ACTUAL
| null | null | null | null | null | null |
2020-09-30
|
2020-10-05
|
ACTUAL
|
2020-03-30
|
ACTUAL
|
2020-03-30
|
2020-09
|
2020-09-30
|
2021-12
|
ESTIMATED
|
2021-12-31
|
2021-06
|
ESTIMATED
|
2021-06-30
| null |
INTERVENTIONAL
| null | null |
An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee
|
A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee
|
WITHDRAWN
| null |
PHASE4
| 0 |
ACTUAL
|
Illinois Center for Orthopaedic Research and Education
| null | 2 | null |
Resources limited secondary to COVID-19 pandemic.
|
f
| null | null | null |
t
|
t
|
f
| null | null |
f
| null | null | null | null | null |
NO
| null |
2024-10-16 05:34:40.88875
|
2024-10-16 05:34:40.88875
|
OTHER
| null | null | null | null | null | null | 2,021 | 0 |
NCT04426695
| null |
2020-06-08
|
2022-05-05
| null |
2023-01-25
|
2020-06-10
|
2020-06-11
|
ACTUAL
|
2022-06-28
|
2022-07-25
|
ACTUAL
| null | null | null |
2023-01-25
|
2023-01-27
|
ACTUAL
|
2020-06-10
|
ACTUAL
|
2020-06-10
|
2023-01
|
2023-01-31
|
2021-10-22
|
ACTUAL
|
2021-10-22
|
2021-05-07
|
ACTUAL
|
2021-05-07
| null |
INTERVENTIONAL
| null |
The full analysis set (FAS) included all randomized participants who received at least one dose (full or partial) of the study drug.
|
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
|
A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19
|
COMPLETED
| null |
PHASE1/PHASE2
| 2,252 |
ACTUAL
|
Regeneron Pharmaceuticals
| null | 4 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null |
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification
|
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
|
https://vivli.org/
|
YES
|
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
|
2024-10-16 05:34:40.88875
|
2024-10-16 05:34:40.88875
|
INDUSTRY
| null | null | null | null | null | null | 2,021 | 1 |
NCT05845359
| null |
2022-10-26
| null | null |
2023-10-16
|
2023-04-25
|
2023-05-06
|
ACTUAL
| null | null | null | null | null | null |
2023-10-16
|
2023-10-18
|
ACTUAL
|
2023-09
|
ESTIMATED
|
2023-09-30
|
2023-10
|
2023-10-31
|
2024-02
|
ESTIMATED
|
2024-02-29
|
2024-02
|
ESTIMATED
|
2024-02-29
| null |
INTERVENTIONAL
| null | null |
Intraoperative Methadone for Postoperative Pain Control
|
Randomized Control Study on the Effectiveness of Intraoperative Methadone on Postoperative Pain Control
|
WITHDRAWN
| null |
PHASE4
| 0 |
ACTUAL
|
Montefiore Medical Center
| null | 2 | null |
IRB approval never received
|
f
| null | null | null | null |
t
|
f
| null | null |
t
| null | null | null | null | null |
NO
| null |
2024-10-16 05:34:40.88875
|
2024-10-16 05:34:40.88875
|
OTHER
| null | null | null | null | null | null | 2,024 | 0 |
NCT03983395
| null |
2019-05-31
| null | null |
2021-05-19
|
2019-06-07
|
2019-06-12
|
ACTUAL
| null | null | null | null | null | null |
2021-05-19
|
2021-05-24
|
ACTUAL
|
2020-04-08
|
ACTUAL
|
2020-04-08
|
2021-05
|
2021-05-31
|
2020-07-24
|
ACTUAL
|
2020-07-24
|
2020-07-24
|
ACTUAL
|
2020-07-24
| null |
INTERVENTIONAL
| null | null |
Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer
|
A Phase 1/2, Open-Label, Dose-Escalation Study of ISB 1302 in Subjects With HER2-Positive Metastatic Breast Cancer
|
TERMINATED
| null |
PHASE1/PHASE2
| 1 |
ACTUAL
|
Ichnos Sciences SA
| null | 8 | null |
The study was terminated during Part 1 (dose escalation), and Part 2 (expansion) of the study was not initiated. This study was voluntarily terminated due to a business decision not to proceed with the ISB 1302 asset, and not due to any safety issue.
|
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-16 05:34:40.88875
|
2024-10-16 05:34:40.88875
|
INDUSTRY
| null | null | null | null | null | null | 2,020 | 0 |
NCT03049449
| null |
2017-02-09
|
2022-04-28
| null |
2022-12-21
|
2017-02-09
|
2017-02-10
|
ACTUAL
|
2022-04-28
|
2022-05-25
|
ACTUAL
| null | null | null |
2022-12-21
|
2023-01-18
|
ACTUAL
|
2017-03-17
|
ACTUAL
|
2017-03-17
|
2022-12
|
2022-12-31
|
2022-01-26
|
ACTUAL
|
2022-01-26
|
2022-01-26
|
ACTUAL
|
2022-01-26
| null |
INTERVENTIONAL
| null |
2 participants who had baseline data collected and were enrolled but not treated, is reported here.
|
T Cells Expressing a Fully-Human Anti-CD30 Chimeric Antigen Receptor for Treating CD30-Expressing Lymphomas
|
Anti-CD30 CAR T Cells With Fully-human Binding Domains for Treating CD30-expressing Lymphomas Including Anaplastic Large Cell Lymphomas
|
COMPLETED
| null |
PHASE1
| 26 |
ACTUAL
|
National Institutes of Health Clinical Center (CC)
| null | 1 | null | null |
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null |
Data will be shared before publication. And at the time of publication or shortly thereafter.
|
An National Institutes of Health (NIH)-funded or approved public repository - Clinical Trials.gov, Biomedical Translational Research Information System (BTRIS), and publication and/or presentations.
| null |
YES
|
We will share coded, linked data in an National Institutes of Health (NIH)-funded or approved public repository. Coded, linked data in Biomedical Translational Research Information System (BTRIS).
|
2024-10-16 05:34:40.88875
|
2024-10-16 05:34:40.88875
|
NIH
| null | null | null | null | null | null | 2,022 | 0 |
NCT04466904
| null |
2020-07-01
| null | null |
2021-07-21
|
2020-07-07
|
2020-07-10
|
ACTUAL
| null | null | null | null | null | null |
2021-07-21
|
2021-07-23
|
ACTUAL
|
2020-09-12
|
ACTUAL
|
2020-09-12
|
2021-07
|
2021-07-31
|
2021-05-28
|
ACTUAL
|
2021-05-28
|
2021-05-28
|
ACTUAL
|
2021-05-28
| null |
INTERVENTIONAL
| null | null |
Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM
|
A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control
|
COMPLETED
| null |
PHASE1/PHASE2
| 42 |
ACTUAL
|
Innovent Biologics (Suzhou) Co. Ltd.
| null | 3 | null | null |
f
| null | null | null |
f
|
f
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
INDUSTRY
| null | null | null | null | null | null | 2,021 | 1 |
NCT03700723
| null |
2018-09-18
| null | null |
2021-01-06
|
2018-10-07
|
2018-10-09
|
ACTUAL
| null | null | null | null | null | null |
2021-01-06
|
2021-01-07
|
ACTUAL
|
2018-12-14
|
ACTUAL
|
2018-12-14
|
2021-01
|
2021-01-31
|
2020-04-15
|
ACTUAL
|
2020-04-15
|
2020-04-15
|
ACTUAL
|
2020-04-15
| null |
INTERVENTIONAL
| null | null |
Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
|
Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
|
TERMINATED
| null |
PHASE2
| 4 |
ACTUAL
|
Entegrion, Inc.
| null | 2 | null |
Convenience of Government Funding Sponsor
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-16 15:54:15.550997
|
2024-10-16 15:54:15.550997
|
INDUSTRY
| null | null | null | null | null | null | 2,020 | 0 |
NCT03273153
| null |
2017-09-01
|
2020-04-14
| null |
2022-08-24
|
2017-09-01
|
2017-09-06
|
ACTUAL
|
2020-05-27
|
2020-06-09
|
ACTUAL
| null | null | null |
2022-08-24
|
2022-09-21
|
ACTUAL
|
2017-12-11
|
ACTUAL
|
2017-12-11
|
2022-08
|
2022-08-31
|
2021-02-19
|
ACTUAL
|
2021-02-19
|
2019-04-15
|
ACTUAL
|
2019-04-15
| null |
INTERVENTIONAL
| null | null |
A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma
|
A Phase III, Open-Label, Multicenter, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma
|
TERMINATED
| null |
PHASE3
| 446 |
ACTUAL
|
Hoffmann-La Roche
| null | 2 | null |
This study was terminated due to benefit/risk analysis.
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-16 15:54:15.550997
|
2024-10-16 15:54:15.550997
|
INDUSTRY
| null | null | null | null | null | null | 2,021 | 0 |
NCT03185819
| null |
2017-06-12
|
2024-03-24
| null |
2024-03-24
|
2017-06-12
|
2017-06-14
|
ACTUAL
|
2024-03-24
|
2024-04-17
|
ACTUAL
| null | null | null |
2024-03-24
|
2024-04-17
|
ACTUAL
|
2017-10-05
|
ACTUAL
|
2017-10-05
|
2024-03
|
2024-03-31
|
2023-03-31
|
ACTUAL
|
2023-03-31
|
2023-03-31
|
ACTUAL
|
2023-03-31
| null |
INTERVENTIONAL
| null |
All baseline characteristics were analyzed on the safety analysis set which included all randomized participants who received at least one dose of DB study drug.
|
Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide
|
A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide
|
COMPLETED
| null |
PHASE2
| 147 |
ACTUAL
|
Janssen Research & Development, LLC
| null | 4 | null | null |
t
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
INDUSTRY
| null |
NCT03829579
|
APPROVED_FOR_MARKETING
| null | null | null | 2,023 | 1 |
NCT03394027
| null |
2018-01-05
|
2021-12-17
| null |
2022-07-28
|
2018-01-06
|
2018-01-09
|
ACTUAL
|
2021-12-17
|
2022-01-12
|
ACTUAL
| null | null | null |
2022-07-28
|
2022-08-23
|
ACTUAL
|
2018-01-17
|
ACTUAL
|
2018-01-17
|
2022-07
|
2022-07-31
|
2021-10-07
|
ACTUAL
|
2021-10-07
|
2021-03-18
|
ACTUAL
|
2021-03-18
| null |
INTERVENTIONAL
| null | null |
ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma
|
A Phase 2 Study of ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma
|
COMPLETED
| null |
PHASE2
| 30 |
ACTUAL
|
National Institutes of Health Clinical Center (CC)
| null | 1 | null | null |
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null |
Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
|
Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
| null |
YES
|
All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to database of Genotypes and Phenotypes (dbGaP).
|
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
NIH
| null | null | null | null | null | null | 2,021 | 0 |
NCT03121586
| null |
2017-04-13
| null | null |
2024-08-13
|
2017-04-17
|
2017-04-20
|
ACTUAL
| null | null | null | null | null | null |
2024-08-13
|
2024-08-15
|
ACTUAL
|
2017-01
|
ACTUAL
|
2017-01-31
|
2024-08
|
2024-08-31
|
2024-06
|
ACTUAL
|
2024-06-30
|
2024-06
|
ACTUAL
|
2024-06-30
| null |
INTERVENTIONAL
| null | null |
Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
|
A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
|
TERMINATED
| null |
PHASE3
| 996 |
ACTUAL
|
ACADIA Pharmaceuticals Inc.
| null | 1 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
INDUSTRY
| null | null | null | null | null | null | 2,024 | 0 |
NCT03008915
| null |
2016-12-22
|
2020-11-30
|
2019-07-30
|
2021-01-28
|
2016-12-30
|
2017-01-04
|
ESTIMATED
|
2021-01-28
|
2021-02-17
|
ACTUAL
|
2020-01-30
|
2020-02-07
|
ACTUAL
|
2021-01-28
|
2021-02-17
|
ACTUAL
|
2017-01
|
ACTUAL
|
2017-01-31
|
2021-01
|
2021-01-31
|
2020-10
|
ACTUAL
|
2020-10-31
|
2018-07
|
ACTUAL
|
2018-07-31
| null |
INTERVENTIONAL
| null |
All participants
|
Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency
|
Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency
|
COMPLETED
| null |
PHASE2
| 15 |
ACTUAL
|
Columbia University
| null | 2 | null | null |
f
| null | null | null |
t
| null | null | null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
OTHER
| null | null | null | null | null | null | 2,020 | 1 |
NCT03097107
| null |
2017-03-24
| null | null |
2023-02-03
|
2017-03-30
|
2017-03-31
|
ACTUAL
| null | null | null | null | null | null |
2023-02-03
|
2023-02-08
|
ACTUAL
|
2017-04-06
|
ACTUAL
|
2017-04-06
|
2023-02
|
2023-02-28
|
2024-01
|
ESTIMATED
|
2024-01-31
|
2023-12
|
ESTIMATED
|
2023-12-31
| null |
INTERVENTIONAL
| null | null |
Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL
|
Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Arm, 12-week Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium 1, 2 and 4 mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL
|
SUSPENDED
| null |
PHASE2
| 124 |
ESTIMATED
|
Zydus Therapeutics Inc.
| null | 4 | null |
Management decision to suspend the study due to recruitment issues
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
|
See above.
|
2024-10-16 15:54:15.550997
|
2024-10-16 15:54:15.550997
|
INDUSTRY
| null | null | null | null | null | null | 2,024 | 0 |
NCT06216561
| null |
2023-12-22
| null | null |
2024-08-16
|
2024-01-16
|
2024-01-22
|
ACTUAL
| null | null | null | null | null | null |
2024-08-16
|
2024-08-20
|
ACTUAL
|
2023-11-30
|
ACTUAL
|
2023-11-30
|
2024-08
|
2024-08-31
|
2024-06-24
|
ACTUAL
|
2024-06-24
|
2024-06-24
|
ACTUAL
|
2024-06-24
| null |
INTERVENTIONAL
| null | null |
Intraperitoneal LSTA1 in CRS-HIPEC
|
A Phase I Trial of Intraperitoneal LSTA1 in Patients Undergoing Cytoreductive Surgery and HIPEC for Peritoneal Surface Malignancy
|
WITHDRAWN
| null |
PHASE1
| 0 |
ACTUAL
|
University of California, San Diego
| null | 2 | null |
closed early due to low (0) accrual
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-16 15:54:15.550997
|
2024-10-16 15:54:15.550997
|
OTHER
| null | null | null | null | null | null | 2,024 | 0 |
NCT05901467
| null |
2023-05-31
| null | null |
2024-05-31
|
2023-06-12
|
2023-06-13
|
ACTUAL
| null | null | null | null | null | null |
2024-05-31
|
2024-06-03
|
ACTUAL
|
2023-10-20
|
ACTUAL
|
2023-10-20
|
2024-05
|
2024-05-31
|
2024-05-29
|
ACTUAL
|
2024-05-29
|
2024-05-29
|
ACTUAL
|
2024-05-29
| null |
INTERVENTIONAL
| null | null |
Recall by Genotype: Neuropeptide Stimulation
|
Recall by Genotype: Neuropeptide Stimulation
|
TERMINATED
| null |
PHASE1
| 16 |
ACTUAL
|
Massachusetts General Hospital
| null | 1 | null |
The study team no longer has access to GnRH. The study has been altered to account for this change and is no longer a clinical trial.
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-16 05:34:40.88875
|
2024-10-16 05:34:40.88875
|
OTHER
| null | null | null | null | null | null | 2,024 | 0 |
NCT05226533
| null |
2022-02-04
| null | null |
2023-02-08
|
2022-02-04
|
2022-02-07
|
ACTUAL
| null | null | null | null | null | null |
2023-02-08
|
2023-02-10
|
ACTUAL
|
2022-03-31
|
ACTUAL
|
2022-03-31
|
2023-02
|
2023-02-28
|
2022-12-21
|
ACTUAL
|
2022-12-21
|
2022-12-16
|
ACTUAL
|
2022-12-16
| null |
INTERVENTIONAL
| null | null |
Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.
|
A Phase 2, Double Blind, Randomized, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of DWRX2003 in Combination With Remdesivir Following Intramuscular Administration in Moderate-Severe COVID-19 Patients
|
TERMINATED
| null |
PHASE2
| 1 |
ACTUAL
|
Daewoong Pharmaceutical Co. LTD.
| null | 3 | null |
Study stopped due to difficulties in patient recruitment
|
f
| null | null | null |
t
|
f
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-16 15:54:15.550997
|
2024-10-16 15:54:15.550997
|
INDUSTRY
| null | null | null | null | null | null | 2,022 | 0 |
NCT04437199
| null |
2020-06-11
| null | null |
2024-02-07
|
2020-06-16
|
2020-06-18
|
ACTUAL
| null | null | null | null | null | null |
2024-02-07
|
2024-02-08
|
ACTUAL
|
2020-12-17
|
ACTUAL
|
2020-12-17
|
2024-02
|
2024-02-29
|
2022-02-07
|
ACTUAL
|
2022-02-07
|
2022-02-07
|
ACTUAL
|
2022-02-07
| null |
INTERVENTIONAL
| null | null |
Tricaprilin Phase 2 Pilot Study in Migraine
|
A 12-Week, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-SD-03 in Participants With Migraine
|
COMPLETED
| null |
PHASE2
| 83 |
ACTUAL
|
Cerecin
| null | 2 | null | null |
f
| null | null | null |
t
|
f
|
f
| null | null |
f
| null | null | null | null | null |
NO
| null |
2024-10-16 15:54:15.550997
|
2024-10-16 15:54:15.550997
|
INDUSTRY
| null | null | null | null | null | null | 2,022 | 1 |
NCT02028221
| null |
2014-01-02
|
2021-02-17
|
2020-09-22
|
2023-06-02
|
2014-01-03
|
2014-01-07
|
ESTIMATED
|
2021-02-17
|
2021-03-12
|
ACTUAL
|
2020-09-28
|
2020-10-05
|
ACTUAL
|
2023-06-02
|
2023-06-27
|
ACTUAL
|
2014-03-07
|
ACTUAL
|
2014-03-07
|
2023-06
|
2023-06-30
|
2022-06-14
|
ACTUAL
|
2022-06-14
|
2018-11-30
|
ACTUAL
|
2018-11-30
| null |
INTERVENTIONAL
| null | null |
Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk
|
Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk
|
COMPLETED
| null |
PHASE2
| 151 |
ACTUAL
|
University of Arizona
| null | 2 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null |
t
| null | null | null | null | null | null | null |
2024-10-16 16:00:55.776746
|
2024-10-16 16:00:55.776746
|
OTHER
| null | null | null | null | null | null | 2,022 | 1 |
NCT04270760
| null |
2020-02-13
|
2023-08-01
|
2022-10-20
|
2023-08-24
|
2020-02-13
|
2020-02-17
|
ACTUAL
|
2023-08-01
|
2023-08-23
|
ACTUAL
|
2022-10-20
|
2022-10-24
|
ACTUAL
|
2023-08-24
|
2023-09-07
|
ACTUAL
|
2020-07-28
|
ACTUAL
|
2020-07-28
|
2023-08
|
2023-08-31
|
2022-11-08
|
ACTUAL
|
2022-11-08
|
2021-12-27
|
ACTUAL
|
2021-12-27
| null |
INTERVENTIONAL
| null |
Full Analysis Set (FAS): includes all randomized participants who received at least one dose of IP.
|
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
|
A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) in Subjects With Elevated Lipoprotein(a)
|
COMPLETED
| null |
PHASE2
| 281 |
ACTUAL
|
Amgen
| null | 5 | null | null |
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null |
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
|
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
|
https://www.amgen.com/datasharing
|
YES
|
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
|
2024-10-16 05:34:40.88875
|
2024-10-16 05:34:40.88875
|
INDUSTRY
| null | null | null | null | null | null | 2,022 | 1 |
NCT02685709
| null |
2016-01-28
|
2021-09-29
| null |
2022-03-24
|
2016-02-14
|
2016-02-19
|
ESTIMATED
|
2022-03-24
|
2022-04-22
|
ACTUAL
| null | null | null |
2022-03-24
|
2022-04-22
|
ACTUAL
|
2016-02
|
ACTUAL
|
2016-02-29
|
2022-03
|
2022-03-31
|
2021-08
|
ACTUAL
|
2021-08-31
|
2020-10
|
ACTUAL
|
2020-10-31
| null |
INTERVENTIONAL
|
MPOWERED
|
Acromegaly patients who previously tolerated and demonstrated a biochemical control on SRLs
|
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
|
A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands
|
COMPLETED
| null |
PHASE3
| 146 |
ACTUAL
|
Chiasma, Inc.
| null | 4 | null | null |
f
| null | null | null |
t
| null | null | null | null | null | null | null | null | null | null |
NO
| null |
2024-10-16 05:34:40.88875
|
2024-10-16 05:34:40.88875
|
INDUSTRY
| null | null | null | null | null | null | 2,021 | 1 |
NCT03488147
| null |
2018-03-28
| null | null |
2020-11-20
|
2018-04-03
|
2018-04-04
|
ACTUAL
| null | null | null | null | null | null |
2020-11-20
|
2020-11-23
|
ACTUAL
|
2020-07
|
ESTIMATED
|
2020-07-31
|
2020-11
|
2020-11-30
|
2020-07-02
|
ACTUAL
|
2020-07-02
|
2020-07-02
|
ACTUAL
|
2020-07-02
| null |
INTERVENTIONAL
| null | null |
Whether Proton Pump Inhibitors, Administered Prior to or After Surgery, Can Reduce the Incidence and/or Severity of Difficulty Swallowing Foods and/or Liquids,Following Anterior Cervical Surgery
|
The Effect of Esomeprazole Magnesium on Incidence of Dysphagia Following Anterior Cervical Spine Surgery: A Prospective, Randomized, Double Blinded, Placebo-Controlled Study
|
WITHDRAWN
| null |
PHASE2
| 0 |
ACTUAL
|
Icahn School of Medicine at Mount Sinai
| null | 3 | null |
Change in Investigational Drug Service policies resulting in the need to change the operational design of the overall protocol.
|
f
| null | null | null |
t
|
t
|
f
| null | null |
t
| null | null | null | null | null | null | null |
2024-10-16 16:00:55.776746
|
2024-10-16 16:00:55.776746
|
OTHER
| null | null | null | null | null | null | 2,020 | 0 |
NCT02625974
| null |
2015-12-07
|
2019-07-22
| null |
2024-03-21
|
2015-12-07
|
2015-12-09
|
ESTIMATED
|
2019-10-10
|
2019-10-29
|
ACTUAL
| null | null | null |
2024-03-21
|
2024-08-19
|
ACTUAL
|
2016-01-27
|
ACTUAL
|
2016-01-27
|
2024-03
|
2024-03-31
|
2021-08-10
|
ACTUAL
|
2021-08-10
|
2018-07-25
|
ACTUAL
|
2018-07-25
| null |
INTERVENTIONAL
| null | null |
A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi
|
Prospective, Historically Controlled Study to Evaluate the Efficacy and Safety of a New Pediatric Formulation of Nifurtimox in Children Aged 0 to 17 Years With Chagas' Disease
|
COMPLETED
| null |
PHASE3
| 330 |
ACTUAL
|
Bayer
|
Abnormal findings on neurological examination by physical examination after Screening will be documented as AEs.
| 2 | null | null |
f
| null | null | null |
t
| null |
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-16 16:00:55.776746
|
2024-10-16 16:00:55.776746
|
INDUSTRY
| null | null | null | null | null | null | 2,021 | 1 |
NCT03615924
| null |
2018-06-22
|
2021-02-05
| null |
2021-03-15
|
2018-07-31
|
2018-08-06
|
ACTUAL
|
2021-03-15
|
2021-04-09
|
ACTUAL
| null | null | null |
2021-03-15
|
2021-04-09
|
ACTUAL
|
2018-09-26
|
ACTUAL
|
2018-09-26
|
2021-03
|
2021-03-31
|
2020-08-13
|
ACTUAL
|
2020-08-13
|
2020-08-13
|
ACTUAL
|
2020-08-13
| null |
INTERVENTIONAL
|
HESTIA3
|
The Full Analysis Set (FAS) included all randomized participants regardless of treatment received.
|
Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease
|
A Randomised, Double-Blind, Parallel-Group, Multicentre, Phase III Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing the Rate of Vaso-Occlusive Crises in Paediatric Patients With Sickle Cell Disease (HESTIA3)
|
TERMINATED
| null |
PHASE3
| 193 |
ACTUAL
|
AstraZeneca
|
AstraZeneca took the decision to terminate the study early, following a recommendation from the independent Data Monitoring Committee. This early termination was not considered to have had an impact on the robustness of the study results.
| 2 | null |
Recommendation from an independent data monitoring committee (DMC) and accepted by AstraZeneca.
|
f
| null | null | null |
t
|
t
|
f
| null | null |
f
| null | null |
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
|
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
|
https://astrazenecagroup-dt.pharmacm.com/DT/Home
|
YES
|
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
|
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
INDUSTRY
| null | null | null | null | null | null | 2,020 | 0 |
NCT02777580
| null |
2016-05-13
|
2024-01-23
| null |
2024-07-09
|
2016-05-17
|
2016-05-19
|
ESTIMATED
|
2024-07-09
|
2024-10-04
|
ACTUAL
| null | null | null |
2024-07-09
|
2024-10-04
|
ACTUAL
|
2017-08-01
|
ACTUAL
|
2017-08-01
|
2024-07
|
2024-07-31
|
2023-09-30
|
ACTUAL
|
2023-09-30
|
2022-10-13
|
ACTUAL
|
2022-10-13
| null |
INTERVENTIONAL
|
STREAM-2
| null |
STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
|
STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
|
COMPLETED
| null |
PHASE4
| 609 |
ACTUAL
|
KU Leuven
| null | 2 | null | null |
f
| null | null | null |
t
|
f
|
f
| null | null | null | null | null | null | null | null |
UNDECIDED
| null |
2024-10-16 16:00:55.776746
|
2024-10-16 16:00:55.776746
|
OTHER
| null | null | null | null | null | null | 2,023 | 1 |
NCT04857138
| null |
2021-04-22
| null | null |
2024-02-02
|
2021-04-22
|
2021-04-23
|
ACTUAL
| null | null | null | null | null | null |
2024-02-02
|
2024-02-05
|
ACTUAL
|
2021-05-18
|
ACTUAL
|
2021-05-18
|
2024-02
|
2024-02-29
|
2024-01-18
|
ACTUAL
|
2024-01-18
|
2024-01-18
|
ACTUAL
|
2024-01-18
| null |
INTERVENTIONAL
| null | null |
A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors
|
An Open-Label, Multicenter, Dose-Escalation and Expansion, Phase I Study to Evaluate Safety, Pharmacokinetics, And Anti-Tumor Activity of RO7300490, A Fibroblast Activation Protein-α (FAP) Targeted CD40 Agonist, as Single Agent or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
|
COMPLETED
| null |
PHASE1
| 80 |
ACTUAL
|
Hoffmann-La Roche
| null | 3 | null | null |
f
| null | null | null | null |
f
|
f
| null | null | null | null | null | null | null | null | null | null |
2024-10-16 16:00:55.776746
|
2024-10-16 16:00:55.776746
|
INDUSTRY
| null | null | null | null | null | null | 2,024 | 1 |
NCT02950558
| null |
2016-10-04
|
2020-12-11
| null |
2021-06-30
|
2016-10-27
|
2016-11-01
|
ESTIMATED
|
2021-06-30
|
2021-07-02
|
ACTUAL
| null | null | null |
2021-06-30
|
2021-07-02
|
ACTUAL
|
2018-05-29
|
ACTUAL
|
2018-05-29
|
2021-06
|
2021-06-30
|
2020-06-19
|
ACTUAL
|
2020-06-19
|
2019-11-14
|
ACTUAL
|
2019-11-14
| null |
INTERVENTIONAL
| null | null |
Anesthesia for Pain After Ankle Fracture Surgery
|
Pilot Study: Extended Regional Anesthesia to Prevent Chronic Pain After Ankle Fracture Surgery
|
COMPLETED
| null |
PHASE4
| 14 |
ACTUAL
|
University of Cincinnati
|
A problem encountered was that only 1 of the 6 subjects in the pump group received the full 5 days of treatment. The others discontinued using the pump early, primarily due to problems with catheter dislodgement/leakage. As specified in the statistical analysis plan, these subjects were all analyzed with intent-to-treat protocol and are included in the pump group data presented. Also, by chance, the distribution of males and females between the group was quite uneven.
| 2 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
OTHER
| null | null | null | null | null | null | 2,020 | 1 |
NCT04379713
| null |
2020-05-06
|
2023-05-18
| null |
2023-05-18
|
2020-05-06
|
2020-05-07
|
ACTUAL
|
2023-05-18
|
2023-06-13
|
ACTUAL
| null | null | null |
2023-05-18
|
2023-06-13
|
ACTUAL
|
2020-05-21
|
ACTUAL
|
2020-05-21
|
2023-05
|
2023-05-31
|
2022-08-31
|
ACTUAL
|
2022-08-31
|
2022-08-31
|
ACTUAL
|
2022-08-31
| null |
INTERVENTIONAL
| null |
Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received any incorrect study vaccination during the study was excluded.
|
20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
|
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
|
COMPLETED
| null |
PHASE3
| 1,511 |
ACTUAL
|
Pfizer
| null | 2 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null |
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
|
YES
|
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
|
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
INDUSTRY
| null | null | null | null | null | null | 2,022 | 0 |
NCT03103971
| null |
2017-03-27
| null | null |
2024-04-08
|
2017-03-31
|
2017-04-07
|
ACTUAL
| null | null | null | null | null | null |
2024-04-08
|
2024-04-10
|
ACTUAL
|
2017-11-03
|
ACTUAL
|
2017-11-03
|
2024-04
|
2024-04-30
|
2024-03-23
|
ACTUAL
|
2024-03-23
|
2023-03-23
|
ACTUAL
|
2023-03-23
| null |
INTERVENTIONAL
| null | null |
huJCAR014 CAR-T Cells in Treating Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia
|
A Two-Stage Phase 1 Open-Label Study of huJCAR014, CD19-Targeted Chimeric Antigen Receptor (CAR)-Modified T Cells Bearing a Human Binding Domain, in Adult Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Acute Lymphocytic Leukemia
|
TERMINATED
| null |
PHASE1
| 55 |
ACTUAL
|
Fred Hutchinson Cancer Center
| null | 1 | null |
Terminated due to slow enrollment and end of funding
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
OTHER
| null | null | null | null | null | null | 2,024 | 0 |
NCT04428047
| null |
2020-06-02
| null | null |
2022-03-28
|
2020-06-09
|
2020-06-11
|
ACTUAL
| null | null | null | null | null | null |
2022-03-28
|
2022-04-06
|
ACTUAL
|
2021-02-04
|
ACTUAL
|
2021-02-04
|
2022-03
|
2022-03-31
|
2022-01-07
|
ACTUAL
|
2022-01-07
|
2021-09-04
|
ACTUAL
|
2021-09-04
| null |
INTERVENTIONAL
|
ICING
| null |
Evaluation of Bintrafusp Alfa in Operable and Untreated Head and Neck Squamous Cell Carcinoma
|
A Phase II Trial Assessing Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in a Pre-operative Setting for Resectable and Untreated Head and Neck Squamous Cell Carcinoma
|
TERMINATED
| null |
PHASE2
| 7 |
ACTUAL
|
UNICANCER
| null | 1 | null |
Sponsor decision following information on cases of hyperprogression and early toxicities with bintrafusp alfa in other studies
|
f
| null | null | null |
t
|
f
|
f
| null | null | null | null | null | null | null | null |
NO
|
Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
|
2024-10-16 05:34:40.88875
|
2024-10-16 05:34:40.88875
|
OTHER
| null | null | null | null | null | null | 2,022 | 0 |
NCT02627963
| null |
2015-12-09
|
2020-01-16
| null |
2023-06-27
|
2015-12-10
|
2015-12-11
|
ESTIMATED
|
2020-02-10
|
2020-02-20
|
ACTUAL
| null | null | null |
2023-06-27
|
2023-07-18
|
ACTUAL
|
2016-05-24
|
ACTUAL
|
2016-05-24
|
2023-06
|
2023-06-30
|
2021-06-21
|
ACTUAL
|
2021-06-21
|
2018-10-04
|
ACTUAL
|
2018-10-04
| null |
INTERVENTIONAL
| null | null |
A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)
|
A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma
|
COMPLETED
| null |
PHASE3
| 350 |
ACTUAL
|
AVEO Pharmaceuticals, Inc.
| null | 2 | null | null |
f
| null | null | null |
f
| null | null | null | null | null | null | null | null | null | null |
UNDECIDED
| null |
2024-10-16 16:00:55.776746
|
2024-10-16 16:00:55.776746
|
INDUSTRY
| null | null | null | null | null | null | 2,021 | 1 |
NCT02666742
| null |
2016-01-25
|
2021-07-30
| null |
2022-08-18
|
2016-01-25
|
2016-01-28
|
ESTIMATED
|
2021-08-30
|
2021-09-24
|
ACTUAL
| null | null | null |
2022-08-18
|
2022-08-22
|
ACTUAL
|
2017-02-16
|
ACTUAL
|
2017-02-16
|
2021-08
|
2021-08-31
|
2021-04-30
|
ACTUAL
|
2021-04-30
|
2020-05-01
|
ACTUAL
|
2020-05-01
| null |
INTERVENTIONAL
|
STROKE-VT
|
Patients undergoing VT or PVC ablation are enrolled into the study. Baseline characteristics of patients including demographics, comorbidities, cardiac function etc were collected and analyzed
|
DOACs for Stroke Prevention Post Ventricular Tachycardia Ablation
|
SafeTy and Efficacy of Direct Oral Anticoagulant Versus Aspirin for Reduction Of RisK of CErebrovascular Events in Patients Undergoing Ventricular Tachycardia Ablation (STROKE-VT)
|
COMPLETED
| null |
PHASE4
| 246 |
ACTUAL
|
Kansas City Heart Rhythm Institute
|
Our results should be considered in light of several significant limitations. An important limitation was the lack of long-term follow-up and quality-of-life and neurocognitive function information. Another methodological limitation of the outcomes was that the ASA group did not get a loading dose, perhaps the delay in achieving the therapeutic effects in denovo ASA initiation could increase the risk of events.
| 2 | null | null |
f
| null | null | null |
t
|
t
|
f
| null | null |
f
| null | null | null | null | null |
NO
| null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
OTHER
| null | null | null | null | null | null | 2,021 | 1 |
NCT02959658
| null |
2016-11-08
| null | null |
2020-12-22
|
2016-11-08
|
2016-11-09
|
ESTIMATED
| null | null | null | null | null | null |
2020-12-22
|
2020-12-24
|
ACTUAL
|
2016-12
|
ACTUAL
|
2016-12-31
|
2020-12
|
2020-12-31
|
2020-12-09
|
ACTUAL
|
2020-12-09
|
2019-12-21
|
ACTUAL
|
2019-12-21
| null |
INTERVENTIONAL
|
FUMAPMS
| null |
Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis
|
Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis
|
COMPLETED
| null |
PHASE2
| 54 |
ACTUAL
|
Rigshospitalet, Denmark
| null | 2 | null | null |
f
| null | null | null |
t
| null | null | null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
OTHER
| null | null | null | null | null | null | 2,020 | 0 |
NCT05293106
| null |
2022-03-14
|
2024-06-17
| null |
2024-07-30
|
2022-03-14
|
2022-03-24
|
ACTUAL
|
2024-07-30
|
2024-08-20
|
ACTUAL
| null | null | null |
2024-07-30
|
2024-08-20
|
ACTUAL
|
2022-07-05
|
ACTUAL
|
2022-07-05
|
2024-07
|
2024-07-31
|
2023-09-27
|
ACTUAL
|
2023-09-27
|
2023-09-17
|
ACTUAL
|
2023-09-17
| null |
INTERVENTIONAL
|
PEDITREC
| null |
Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial
|
Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial
|
TERMINATED
| null |
PHASE4
| 9 |
ACTUAL
|
Weill Medical College of Cornell University
|
Due to difficulty in recruiting and enrolling subjects, only descriptive statistics were used to describe the 9 enrolled subjects.
| 3 | null |
Difficulty recruiting and enrolling subjects.
|
f
| null | null | null |
t
|
t
|
f
| null | null |
f
| null | null | null | null | null |
NO
| null |
2024-10-16 16:00:55.776746
|
2024-10-16 16:00:55.776746
|
OTHER
| null | null | null | null | null | null | 2,023 | 0 |
NCT04365400
| null |
2020-04-24
|
2023-05-05
| null |
2023-06-08
|
2020-04-24
|
2020-04-28
|
ACTUAL
|
2023-05-05
|
2023-06-01
|
ACTUAL
| null | null | null |
2023-06-08
|
2023-06-12
|
ACTUAL
|
2020-10-13
|
ACTUAL
|
2020-10-13
|
2023-06
|
2023-06-30
|
2022-05-03
|
ACTUAL
|
2022-05-03
|
2022-05-03
|
ACTUAL
|
2022-05-03
| null |
INTERVENTIONAL
|
TRIAGE
|
Safety Analysis Set: The SAS consists of all patients who received at least one dose of the study medication.
|
Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes
|
A Randomised, Double-Blind, Placebo-Controlled, Dose Finding Phase IIb Study to Assess the Efficacy and Safety of Orally Administered Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes
|
TERMINATED
| null |
PHASE2
| 233 |
ACTUAL
|
Afimmune
| null | 3 | null |
Trial prematurely terminated on 03 May 2022 due to the results from an interim analysis indicating a lack of efficacy in the study population.
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-15 17:39:08.361117
|
2024-10-15 17:39:08.361117
|
INDUSTRY
| null | null | null | null | null | null | 2,022 | 0 |
NCT04530747
| null |
2020-08-25
|
2022-11-21
| null |
2022-12-21
|
2020-08-25
|
2020-08-28
|
ACTUAL
|
2022-12-21
|
2023-01-19
|
ACTUAL
| null | null | null |
2022-12-21
|
2023-01-19
|
ACTUAL
|
2021-01-28
|
ACTUAL
|
2021-01-28
|
2022-12
|
2022-12-31
|
2021-11-30
|
ACTUAL
|
2021-11-30
|
2021-11-30
|
ACTUAL
|
2021-11-30
| null |
INTERVENTIONAL
|
MET-OSA
| null |
Metabolic Effects of Metformin Therapy in Obstructive Sleep Apnea
|
Metabolic Effects of Metformin Therapy in Obstructive Sleep Apnea
|
TERMINATED
| null |
PHASE1/PHASE2
| 16 |
ACTUAL
|
Pennington Biomedical Research Center
|
Early termination due to PAP recall.
| 2 | null |
Recall of positive airway pressure (PAP) device.
|
f
| null | null | null |
f
|
t
|
f
| null | null |
f
| null | null | null | null | null | null | null |
2024-10-15 18:03:23.937454
|
2024-10-15 18:03:23.937454
|
OTHER
| null | null | null | null | null | null | 2,021 | 0 |
NCT01468311
| null |
2011-11-05
|
2017-04-17
| null |
2021-09-16
|
2011-11-05
|
2011-11-09
|
ESTIMATED
|
2017-04-17
|
2017-05-25
|
ACTUAL
| null | null | null |
2021-09-16
|
2021-10-06
|
ACTUAL
|
2011-10-11
|
ACTUAL
|
2011-10-11
|
2021-09
|
2021-09-30
|
2020-10-22
|
ACTUAL
|
2020-10-22
|
2014-11-16
|
ACTUAL
|
2014-11-16
| null |
INTERVENTIONAL
| null | null |
Yttrium-90-labeled Daclizumab With Chemotherapy and Stem Cell Transplant for Hodgkin's Lymphoma
|
Phase I/II Trial of Yttrium-90-labeled Daclizumab (Anti-CD25) Radioimmunotherapy With High-dose BEAM Chemotherapy and Autologous Hematopoietic Stem Cell Rescue in Recurrent and Refractory Hodgkin's Lymphoma
|
TERMINATED
| null |
PHASE1/PHASE2
| 6 |
ACTUAL
|
National Institutes of Health Clinical Center (CC)
| null | 1 | null |
Poor enrollment and ability to radioconjugate Daclizumab. Neither Center for Cancer Research (CCR) or Nuclear Medicine/Radiology wanted to do the facilities upgrade and hire personnel needed to radioconjugate the drug at the Clinical Center.
|
f
| null | null | null |
f
|
t
|
f
| null | null | null | null | null | null | null | null |
NO
| null |
2024-10-16 05:34:40.88875
|
2024-10-16 05:34:40.88875
|
NIH
| null | null | null | null | null | null | 2,020 | 0 |
NCT03492138
| null |
2018-03-22
| null | null |
2020-05-27
|
2018-04-02
|
2018-04-10
|
ACTUAL
| null | null | null | null | null | null |
2020-05-27
|
2020-05-29
|
ACTUAL
|
2018-03-26
|
ACTUAL
|
2018-03-26
|
2020-05
|
2020-05-31
|
2020-01-14
|
ACTUAL
|
2020-01-14
|
2020-01-14
|
ACTUAL
|
2020-01-14
| null |
INTERVENTIONAL
| null | null |
Ixazomib, ONC201, and Dexamethasone in Relapsed/Refractory Multiple Myeloma
|
A Phase I/II Study of the Addition of Ixazomib to ONC201 and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
|
TERMINATED
| null |
PHASE1/PHASE2
| 5 |
ACTUAL
|
Icahn School of Medicine at Mount Sinai
| null | 1 | null |
Low enrollment
|
f
| null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
UNDECIDED
|
Data and safety will be monitored using an internal Data and Safety Monitoring Plan (DSMP) led by the PI. Other members involved with the review will include sub-Investigators, the myeloma research program manager, and clinical research coordinators. All of these individuals have experience in the routine clinical care as well clinical research and monitoring of subjects with multiple myeloma. A statistician will also be involved with the review.
|
2024-10-16 16:00:55.776746
|
2024-10-16 16:00:55.776746
|
OTHER
| null | null | null | null | null | null | 2,020 | 0 |
NCT04852978
| null |
2021-04-19
|
2023-11-20
| null |
2024-07-25
|
2021-04-19
|
2021-04-21
|
ACTUAL
|
2024-07-25
|
2024-08-20
|
ACTUAL
| null | null | null |
2024-07-25
|
2024-08-20
|
ACTUAL
|
2021-04-29
|
ACTUAL
|
2021-04-29
|
2024-07
|
2024-07-31
|
2022-11-21
|
ACTUAL
|
2022-11-21
|
2022-11-21
|
ACTUAL
|
2022-11-21
| null |
INTERVENTIONAL
| null |
The safety analysis set (SAF) includes all randomized subjects who have been vaccinated with at least one dose or received any study drug
|
COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers
|
A Phase 2 Randomized, Open-Label, Parallel Group Study to Assess the Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers
|
COMPLETED
| null |
PHASE2
| 295 |
ACTUAL
|
Regeneron Pharmaceuticals
| null | 12 | null | null |
t
| null | null | null |
f
|
t
|
f
| null | null | null | null | null |
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
|
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
|
https://vivli.org/
|
YES
|
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
|
2024-10-16 16:00:55.776746
|
2024-10-16 16:00:55.776746
|
INDUSTRY
| null |
NCT04617535
|
NO_LONGER_AVAILABLE
| null | null | null | 2,022 | 1 |
NCT03930732
| null |
2019-04-26
|
2024-01-30
| null |
2024-01-30
|
2019-04-26
|
2019-04-29
|
ACTUAL
|
2024-01-30
|
2024-02-28
|
ACTUAL
| null | null | null |
2024-01-30
|
2024-02-28
|
ACTUAL
|
2019-04-15
|
ACTUAL
|
2019-04-15
|
2024-01
|
2024-01-31
|
2023-05-02
|
ACTUAL
|
2023-05-02
|
2023-02-08
|
ACTUAL
|
2023-02-08
| null |
INTERVENTIONAL
|
BOREAS
|
The Randomized population consisted of any participant who was allocated to a randomized treatment regardless of whether the treatment kit was used.
|
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
|
A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation
|
COMPLETED
| null |
PHASE3
| 939 |
ACTUAL
|
Sanofi
| null | 2 | null | null | null | null | null | null |
t
|
t
|
f
| null | null | null | null | null | null | null | null |
YES
|
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
|
2024-10-16 16:00:55.776746
|
2024-10-16 16:00:55.776746
|
INDUSTRY
| null | null | null | null | null | null | 2,023 | 1 |
Subsets and Splits
SQL Console for chufangao/CTO
Returns the top 10 records with the highest but not maximum prediction probabilities, which can be useful for examining uncertain predictions.
SQL Console for chufangao/CTO
The query retrieves records with prediction probabilities less than 1, ordered by descending probability, which provides basic filtering but little analytical insight.