chufangao/CTO huggingface dataset:
Clinical trial NCT01790035: Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer
Official title: A Phase I and Randomized Controlled Phase II Trial of the Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer
Acronym: LGG
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 23.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-08-19
Primary completion date: 2017-01-12
Completion date: 2021-12-12
Plan to share individual participant data: NO
Clinical trial NCT03905564: A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions
Official title: Single Site, Open-label, Randomized, Two Treatments, Two Periods, Two Sequences, Crossover Trial to Evaluate the Bioequivalence of Two Delayed-release Oral Formulations of a Fixed Combination of Doxylamine Succinate 10 mg/Pyridoxine Hydrochloride 10 mg (Test Product: Product of Tecnandina, S.A. TENSA; Reference Product: Diclegis (Registered Trademark) Product of Duchesnay Inc.) After a Single Administration of Two Tablets to Healthy Women Under Fasting Conditions
Sponsor: Grünenthal GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Sponsor decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-30
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Plan to share individual participant data: NO
Clinical trial NCT04432103: Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma
Official title: Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma
Sponsor: Centro Medico ABC (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: There is new evidence that the Convalescent plasma is not useful for severe and critical COVID-19 Pneumonia
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-08
Primary completion date: 2021-01-29
Completion date: 2021-01-29
Plan to share individual participant data: NO
Clinical trial NCT04542681: MANP in African Americans With Hypertension
Official title: A Phase I, Single-Blind, Placebo-Controlled Study Evaluating the Cardiovascular Properties of MANP in African Americans With Hypertension
Acronym: MANP-2
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study was withdrawn and replaced by a larger study
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-05-01
Primary completion date: 2022-12-30
Completion date: 2023-06-30
Clinical trial NCT03038620: Impact of Liraglutide 3.0 on Body Fat Distribution
Official title: Impact of Liraglutide 3.0 on Body Fat Distribution, Visceral Adiposity, and Cardiometabolic Risk Markers In Overweight and Obese Adults at High Risk for Cardiovascular Disease
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 235.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-31
Primary completion date: 2020-10-13
Completion date: 2020-10-13
Baseline population: Participants analyzed if they completed an endpoint assessment and had interpretable imaging data.
Limitations and caveats: Results reported according to updated statistical analysis plan published 7/28/2020 on CT.gov website. The updated 7/28/2020 analysis plan accounted for changes in data collection (blood biomarkers) during COVID-19 pandemic and was submitted and published prior to study completion and prior to study un-blinding with updated terminology for study endpoints compared to original protocol.
Plan to share individual participant data: NO
Clinical trial NCT02790710: Brief Intervention for OCD Fears
Official title: Brief Intervention for OCD Fears
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Study has been withdrawn due to reconsideration of study design.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-30
Primary completion date: 2023-04-30
Completion date: 2023-04-30
Plan to share individual participant data: NO
Clinical trial NCT04430855: A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms
Official title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 68.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-14
Primary completion date: 2021-04-22
Completion date: 2022-01-25
Baseline population: The Intent-to-treat (ITT) population includes all randomized participants
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT05442684: A Study to Evaluate the Safety and Immunogenicity of Ad5-vector Based Vaccine Against Coronavirus Variants in Adults (≥18 Years) Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine
Official title: A Multicenter, Randomized, and Observer-blind Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-based COVID-19 Vaccine Against Coronavirus Variants in Adults (≥ 18 Years) Who Have Been Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine
Sponsor: CanSino Biologics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: The trial protocol was not approved by the regulatory authorities.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-11-30
Primary completion date: 2023-03-30
Completion date: 2023-06-30
Plan to share individual participant data: NO
Clinical trial NCT04361149: Motor Unit Abnormalities After Experimentally Induced Sensitization
Official title: Evaluation of Motor Unit Abnormalities After Experimentally Induced Sensitization Using Capsaicin: A Randomized, Double-Blinded, Placebo-Controlled Study
Sponsor: Toronto Rehabilitation Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-01
Primary completion date: 2019-12-20
Completion date: 2020-03-10
Plan to share individual participant data: NO
IPD sharing description: The University Health Network has a high importance on patient confidentiality. For ethics approval, this was complied with these standards, upholding the patient confidentiality standard at UHN.
Clinical trial NCT00418821: A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants
Official title: A Multicenter, Multinational, Open-Label Study of the Effects of Aldurazyme® (Laronidase) Treatment on Lactation in Women With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Study was conducted to fulfill a post marketing commitment (PMC). FDA acknowledged closure of PMC.
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2010-10-22
Primary completion date: 2022-12-21
Completion date: 2022-12-21
Limitations and caveats: Study was conducted to fulfill a post marketing commitment (PMC). Upon acknowledgement of closure of PMC by FDA, the study was terminated by the Sponsor.
Plan to share individual participant data: YES
IPD sharing description: 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
Clinical trial NCT04836533: Enhancing Processing Speed and Executive Functioning in Depressed Older Adults With Computerized Cognitive Training
Official title: Optimizing Placebo Effects in Depressed Older Adults: Enhancing Processing Speed and Executive Functioning With Computerized Cognitive Training
Sponsor: Queens College, The City University of New York (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Conflicts at the study site prevented the study from being carried out
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-01-31
Primary completion date: 2023-01-31
Completion date: 2023-01-31
Plan to share individual participant data: NO
Clinical trial NCT04249167: Cryoablation, Atezolizumab/Nab-paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
Official title: Cryoablation and Anti-PD-L1 Immunotherapy for Triple Negative Breast Cancer (TNBC)
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: study was dropped
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-23
Primary completion date: 2021-11-17
Completion date: 2021-11-17
Clinical trial NCT02373241: Preventing Sickle Cell Kidney Disease
Official title: Chronobiology and Chronopharmacology to Prevent Sickle Cell Kidney Disease
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Estimated GFR was determined not to be a reliable endpoint for this study. We identified significant variabilty in annual eGFR that it became inappropriate to randomize to a medication but use EGFR as the primary endpoint.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-04-30
Primary completion date: 2021-02-28
Completion date: 2021-07-31
Baseline population: 1 patient identified as eligible for the study due to ambulatory hypertension
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03743805: Rapid Reversal of CNS-Depressant Drug Effect Prior to Brain Death Determination
Official title: Rapid Reversal of CNS-Depressant Drug Effect Prior to Brain Death Determination
Sponsor: Prisma Health-Midlands (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Insufficient patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-01
Primary completion date: 2021-07-20
Completion date: 2021-07-21
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03209869: Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Expanded Haploidentical NK Cells and Hu14.18-IL2
Official title: Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Ex-Vivo Expanded and Activated Haploidentical NK Cells and Hu14.18-IL2
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: resources limited due to COVID-19
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-12
Primary completion date: 2022-09-07
Completion date: 2022-09-07
Plan to share individual participant data: NO
Clinical trial NCT04321460: Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults.
Official title: Multicentre, Double-blind, Randomized, Placebo-controlled, Parallel-group Efficacy and Safety Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated Diarrhea in Adults.
Sponsor: Sandoz (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 520.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-01
Primary completion date: 2021-01-04
Completion date: 2021-01-04
Plan to share individual participant data: YES
IPD sharing description: 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
Clinical trial NCT04489537: Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B
Official title: Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous Marzeptacog Alfa (Activated) For On Demand Treatment and Control of Bleeding Episodes in Subjects With Hemophilia A or Hemophilia B, With Inhibitors: The Crimson 1 Study
Sponsor: Catalyst Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision (not a safety decision)
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-04
Primary completion date: 2021-11-15
Completion date: 2021-12-01
Plan to share individual participant data: NO
Clinical trial NCT04862741: Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
Official title: A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
Sponsor: Landos Biopharma Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 39.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-05-05
Primary completion date: 2022-06-17
Completion date: 2022-10-05
Plan to share individual participant data: NO
Clinical trial NCT02025881: Study of Sequential High-dose Chemotherapy in Children With High Risk Medulloblastoma
Official title: Phase I / II Study of Sequential High-dose Chemotherapy With Stem Cell Support in Children Younger Than 5 Years of Age With High-risk Medulloblastoma
Acronym: HR MB-5
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Enrollment: 29.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-09-14
Primary completion date: 2020-10-25
Completion date: 2020-10-25
Clinical trial NCT01478698: The Safety and Tolerability of Intra-abdominal t-PA and DNase on Peritonitis in Peritoneal Dialysis Patients
Official title: A Phase 1, Open Label, Non Randomised Safety Trial of Intraperitoneal tPA and DNase in Peritoneal Dialysis Patients With Peritonitis
Sponsor: Sir Charles Gairdner Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Insufficient budget for further study agents
Enrollment: 5.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-01-01
Primary completion date: 2022-05-13
Completion date: 2022-05-13
Clinical trial NCT02571608: Continuation of Metformin to Improve And Keep Peri-operative Glycemic Control
Official title: ContinuAtioN of meTformin to Improve And KEep Peri-operative Glycemic Control: A Randomized, Double-Blind, Placebo-Controlled Pilot Study.
Acronym: CANTAKE
Sponsor: McMaster University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Study halted prematurely, prior to enrollment of first participant
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-01
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Clinical trial NCT03028740: AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
Official title: AURORA: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis
Acronym: AURORA
Sponsor: Tobira Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: This study was terminated early due to lack of efficacy based on the results of the planned interim analysis of Part 1 data.
Enrollment: 1778.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-05
Primary completion date: 2021-01-12
Completion date: 2021-03-09
Baseline population: Modified Intent-to-Treat (mITT) Population for the Full Study Cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined.
Clinical trial NCT03923530: Pressure Assessment to Improve Outcomes After TAVR: a Registry
Official title: Pressure Assessment to Improve Outcomes After TAVR: a Registry
Sponsor: North Florida Foundation for Research and Education (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-03
Primary completion date: 2020-02-20
Completion date: 2020-02-27
Baseline population: 12
Plan to share individual participant data: NO
Clinical trial NCT03851081: Inotuzumab Ozogamicin and Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia
Official title: A Multi-Center, Open-Label Phase 1b/2 Study of Inotuzumab Ozogamicin and Vincristine Sulfate Liposome in Adult Patients With Relapsed/Refractory B Lineage Acute Lymphoblastic Leukemia (B-ALL)
Sponsor: Roswell Park Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: no accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-21
Primary completion date: 2023-01-21
Completion date: 2024-01-21
Clinical trial NCT03556761: Furosemide for Accelerated Recovery of Blood Pressure Postpartum
Official title: Furosemide for Accelerated Recovery of Blood Pressure Postpartum
Acronym: ForBP
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 384.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-20
Primary completion date: 2019-12-04
Completion date: 2020-02-05
Plan to share individual participant data: NO
Clinical trial NCT05734482: Pharmacokinetic, Safety and Immunogenicity Study of CMAB015 and Cosentyx in Healthy Volunteers
Official title: Phase I Comparison of Pharmacokinetics, Safety, and Immunogenicity of CMAB015 Injection and Cosentyx in a Randomized, Double-blind, Parallel Controlled, Single-dose Study in Healthy Chinese Male Subjects
Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 130.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-02-15
Primary completion date: 2023-07-03
Completion date: 2023-07-03
Plan to share individual participant data: NO
Clinical trial NCT04648826: Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With Unresectable Pulmonary Metastases From Sarcomas, Germ Cell Tumors, or Epithelial Malignancies
Official title: Phase I/II Evaluation of Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With Unresectable Pulmonary Metastases From Sarcomas, Germ Cell Tumors, or Epithelial Malignancies
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Due to notification from EMD Serono, for Bintrafusp alfa (M7824) regarding an observed increase in the frequently of early progression and death.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-14
Primary completion date: 2021-12-14
Completion date: 2021-12-14
Clinical trial NCT02037035: Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
Official title: Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-07-31
Primary completion date: 2021-06-30
Completion date: 2021-06-30
Clinical trial NCT02737748: TWB-103 for Adult Patients With Split-Thickness Skin Graft Donor Site Wounds
Official title: A Phase I/II Study to Evaluate the Safety and Efficacy of TWB-103 in Adult Patients With Split-Thickness Skin Graft Donor Site Wounds (DSW)
Sponsor: Transwell Biotech Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 48.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-06
Primary completion date: 2021-05-07
Completion date: 2021-05-07
Baseline population: \[Not Specified\]
Limitations and caveats: Some cases that healing observed by 1st evaluator could not be confirmed due to the lack of following visits. These are considered as flaws of protocol design.
Plan to share individual participant data: NO
Clinical trial NCT03809988: PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)
Official title: International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.
Acronym: PALMIRA
Sponsor: MedSIR (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 198.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-05
Primary completion date: 2022-11-30
Completion date: 2022-11-30
Plan to share individual participant data: YES
IPD sharing description: Study Leaflet V2_20190115 with study design, primary objetive, inclusion criteria and exclusion criteria
IPD time frame: During recruitment period
IPD access criteria: Oncology department
Clinical trial NCT04092452: A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
Official title: A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 16-WEEK STUDY EVALUATING THE SAFETY AND EFFICACY OF PF-06650833, PF-06700841, AND PF-06826647 IN ADULTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 194.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-12-02
Primary completion date: 2022-01-10
Completion date: 2022-01-10
Baseline population: All enrolled participants who received at least one dose of study treatment.
Plan to share individual participant data: YES
IPD sharing description: 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.