chufangao/CTO huggingface dataset:
Clinical trial NCT04434560: Neoadjuvant Immunotherapy in Brain Metastases
Official title: A Phase II Trial of Surgery and Stereotactic Radiosurgery With Neoadjuvant Nivolumab and Ipilimumab in Patients With Surgically-resectable, Solid Tumor Brain Metastases
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Poor enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-04
Primary completion date: 2021-06-17
Completion date: 2021-06-17
Baseline population: No participants were enrolled in the Neoadjuvant Immunotherapy group.
Plan to share individual participant data: NO
Clinical trial NCT04791761: Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy
Official title: Use of a Non-Opioid Pain Regimen for Post-Operative Analgesia Following Intracapsular Adenotonsillectomy
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: slow recruitment
Enrollment: 73.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-04-13
Primary completion date: 2023-07-03
Completion date: 2023-07-03
Baseline population: Excludes patients withdrawn due to protocol violations.
Limitations and caveats: Early termination due to slow recruitment leading to small numbers of subjects analyzed.
Plan to share individual participant data: NO
IPD sharing description: Only co-investigators as listed under the University of Pittsburgh IRB (Institutional Review Board) protocol for this study will have access to all data and analysis. Data will be shared via UPMC-associated OneDrive and will only be shared between these investigators.
Clinical trial NCT01527747: Effects of DPP-4 Inhibition on Triglycerides
Official title: Effects of Dipeptidyl Peptidase-4 Inhibition With Saxagliptin on Fasting and Postprandial Triglyceride Concentrations
Sponsor: Oregon Health and Science University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: SUSPENDED 
Why stopped: Funding
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-01-31
Primary completion date: 2024-11-30
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT03252587: An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 363.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-09-21
Primary completion date: 2021-06-29
Completion date: 2021-10-28
Clinical trial NCT01776840: A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 523.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-05-16
Primary completion date: 2021-06-30
Completion date: 2024-06-24
Clinical trial NCT04956276: Subcutaneous ALXN1830 in Adult Participants With Warm Autoimmune Hemolytic Anemia
Official title: A Phase 2, Multiple Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study of ALXN1830 Administered Subcutaneously in Patients With Warm Autoimmune Hemolytic Anemia (WAIHA)
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor decision to terminate program
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-01-01
Primary completion date: 2022-07-31
Completion date: 2024-07-31
Plan to share individual participant data: YES
Clinical trial NCT02450331: A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
Official title: A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection
Acronym: IMvigor010
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decided to terminate the study early because the study did not meet its primary endpoint and because the study had met its goals of providing safety and additional exploratory efficacy information for atezolizumab monotherapy in MIBC.
Enrollment: 809.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-10-05
Primary completion date: 2019-11-30
Completion date: 2022-06-14
Clinical trial NCT04341311: Phase I Study of Marizomib + Panobinostat for Children With DIPG
Official title: Phase 1 Trial of Marizomib Alone and in Combination With Panobinostat for Children With Diffuse Intrinsic Pontine Glioma
Acronym: DIPG
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Withdrawal of support from BMS
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-10
Primary completion date: 2024-02-14
Completion date: 2024-02-14
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD time frame: Data can be shared no earlier than 1 year following the date of publication
IPD access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Clinical trial NCT02687451: Clinical Study to Evaluate the Effectiveness, Safety, and Tolerability of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
Official title: An Open-Label Single-Dose And Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study To Evaluate The Efficacy, Safety, Tolerability, And Pharmacokinetics Of Oxymorphone Hydrochloride (HCl) For Acute Moderate To Severe Postoperative Pain In Pediatric Subjects
Sponsor: Endo Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Released from PMR
Enrollment: 28.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-04-30
Primary completion date: 2020-07-01
Completion date: 2020-09-15
Clinical trial NCT03430947: Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases
Official title: An Open-label Phase II Multicenter Study of Vemurafenib (Zelboraf®) Plus Cobimetinib (Cotellic®) After Radiosurgery in Patients With Active BRAF-V600-mutant Melanoma Brain Metastases
Acronym: RadioCoBRIM
Sponsor: Technische Universität Dresden (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to insufficient recruitment, the clinical trial was terminated prematurely
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-01
Primary completion date: 2023-02-10
Completion date: 2023-02-10
Plan to share individual participant data: YES
IPD sharing description: After publication of the primary objective, the data might be provided to interested scientists on request (e.g. for meta-analyses or other scientific research) in an anonymized way within 5 years (according to the General Data Protection Regulation), provided that the sponsor and the coordinating principal investigators have given their prior written consent.
IPD time frame: within 5 years
Clinical trial NCT04550338: Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure
Official title: Antiviral Effects of Tranexamic Acid (TXA) as a Preventative Treatment Following COVID-19 Exposure
Acronym: TXACOVIDPREV
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: With vaccination efforts ongoing, a feasibility survey indicated there would be inadequate recruitment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-01
Primary completion date: 2022-12-31
Completion date: 2023-03-31
Plan to share individual participant data: YES
IPD sharing description: all de-identified data would be available upon request
IPD time frame: within one month of request
IPD access criteria: institutional approval
Clinical trial NCT00127205: S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.
Official title: Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
Sponsor: SWOG Cancer Research Network (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 6097.0 (ACTUAL)
Number of arms: 3.0
Start date: 2005-07-31
Primary completion date: 2017-12-31
Completion date: 2021-03-29
Baseline population: Only eligible patients are included in the analysis.
Clinical trial NCT01528618: Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma
Official title: A Randomized, Multicenter Phase III Clinical Trial Comparing Gemcitabine and Cisplatin With 5-Fluorouracil and Cisplatin in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 362.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-02-21
Primary completion date: 2016-04-10
Completion date: 2020-12-20
Clinical trial NCT04225533: SP16 Inflammatory Response Inhibition Trial
Official title: SP16 Inflammatory Response Inhibition Trial
Acronym: SPIRIT
Sponsor: Serpin Pharma, LLC (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-24
Primary completion date: 2021-01-04
Completion date: 2021-12-21
Plan to share individual participant data: NO
Clinical trial NCT02768532: Value of Pharmacokinetic Assays in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease
Official title: VEDO-PREDIRESP Project: Value of Pharmacokinetic Assays (Vedolizumab and Anti-vedolizumab Antibody) in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease
Acronym: VEDO-PREDIRESP
Sponsor: Centre Hospitalier Universitaire de Saint Etienne (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: low inclusion rates
Enrollment: 47.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-07-01
Primary completion date: 2022-01-11
Completion date: 2023-01-23
Plan to share individual participant data: NO
Clinical trial NCT02995642: Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation
Official title: Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Resources not secured
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-31
Primary completion date: 2020-09-30
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT04927884: A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies
Official title: Open-Label Phase 1b/2 Study of Sacituzumab Govitecan-Hziy Plus Chemoimmunotherapy for the Treatment of Subjects With Advanced Triple-Negative Breast Cancer After Prior Therapy
Sponsor: ImmunityBio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: low enrollment
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-08
Primary completion date: 2022-09-13
Completion date: 2022-12-12
Limitations and caveats: The study was terminated early due to low enrollment. Only the safety data is provided.
Plan to share individual participant data: NO
Clinical trial NCT05049850: A Study to Investigate DSA Rebound in Patients Treated with Imlifidase Prior to Transplantation
Official title: An Open Label, Phase II Study to Investigate DSA Rebound in Patients with a Positive Crossmatch, Made Transplantable with Imlifidase
Sponsor: Hansa Biopharma AB (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Company decision, not due to any safety reason
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-16
Primary completion date: 2024-02-05
Completion date: 2024-05-08
Plan to share individual participant data: NO
Clinical trial NCT03091998: Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
Official title: A Phase I Trial to Determine Safety and Efficacy of Chronic Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
Acronym: CD-NP/LVAD
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: No funding available
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-30
Primary completion date: 2019-05-01
Completion date: 2020-05-01
Plan to share individual participant data: NO
Clinical trial NCT03737344: BLOC-ICH: Interleukin-1 Receptor Antagonist in Intracerebral Haemorrhage
Official title: Phase II Trial of Interleukin-1 Receptor Antagonist in Intracerebral Haemorrhage: BLOcking the Cytokine IL-1 in ICH
Acronym: BLOC-ICH
Sponsor: University of Manchester (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-17
Primary completion date: 2021-02-19
Completion date: 2021-04-30
Clinical trial NCT04131322: Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.
Official title: Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH Study
Acronym: ADA-SWITCH
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Sponsor cancellation
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-10
Primary completion date: 2020-06-08
Completion date: 2020-06-08
Plan to share individual participant data: NO
Clinical trial NCT03466333: Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
Official title: Feasibility Study on the Effects of Postnatal Enalapril on Maternal Cardiovascular Function Following Preterm Pre-eclampsia.
Acronym: PICk-UP
Sponsor: Manchester University NHS Foundation Trust (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 118.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-09-05
Primary completion date: 2020-09-11
Completion date: 2020-09-11
Clinical trial NCT05580250: A Study of LY3526318 in Healthy Male Japanese Participants
Official title: A Phase I, Single-Centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of LY3526318, and to Investigate the Effect of LY3526318 on Metformin and Simvastatin Pharmacokinetics in Healthy Male Japanese Participants
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The sponsor made a business decision to withdraw the trial.
Enrollment: 0.0 (ACTUAL)
Number of arms: 5.0
Start date: 2022-11-22
Primary completion date: 2022-12-08
Completion date: 2022-12-08
Plan to share individual participant data: NO
Clinical trial NCT02611908: Obinutuzumab With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib.
Official title: A Phase 1 Clinical Trial to Evaluate Obinutuzumab With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib.
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: No participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-06-30
Primary completion date: 2019-11-30
Completion date: 2020-11-30
Clinical trial NCT03954704: Study of Dalutrafusp Alfa (Formerly GS-1423) in Participants With Advanced Solid Tumors
Official title: A Phase 1a/1b Study of GS-1423, an Anti-CD73-TGFβ-Trap Bifunctional Antibody, as Monotherapy or in Combination With a Chemotherapy Regimen in Subjects With Advanced Solid Tumors
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The decision to discontinue the study was made based on the totality of the clinical, pharmacokinetic, and pharmacodynamic findings. No safety concerns were observed.
Enrollment: 22.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-06-03
Primary completion date: 2020-10-27
Completion date: 2021-04-15
Baseline population: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
Limitations and caveats: Because the study was terminated after enrolling only 22 participants in the dose-escalation stage (Phase 1a Part A), planned analysis was not conducted for Phase 1a Part B, and Phase 1b.
Plan to share individual participant data: NO
Clinical trial NCT04243551: Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients
Official title: Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet While Undergoing Periodic Gluten Exposure
Sponsor: Entero Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to low enrollment related to Covid.
Enrollment: 83.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-01
Primary completion date: 2023-10-16
Completion date: 2023-10-31
Plan to share individual participant data: NO
Clinical trial NCT04599075: Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus
Official title: Intravenous Insulin Versus Subcutaneous Insulin Infusion in Intrapartum Management of Pregnant Women With Type 1 Diabetes Mellitus: A Randomized Trial
Sponsor: University of Massachusetts, Worcester (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 70.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-15
Primary completion date: 2023-05-01
Completion date: 2023-05-02
Plan to share individual participant data: NO
Clinical trial NCT03037593: High Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High Risk Pregnant Women
Official title: A Randomized Single-Center Study of the Effects of High-Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High-Risk Pregnant Women
Sponsor: University of Minnesota (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Failure to recruit adequate patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-01
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03393000: Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects
Official title: Open-label, Randomized, Controlled, Phase 3 Safety and Efficacy Study of Trans Sodium Crocetinate With Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects
Acronym: INTACT
Sponsor: Diffusion Pharmaceuticals Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Business decision on behalf of the Sponsor.
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-16
Primary completion date: 2020-11-06
Completion date: 2020-11-06
Limitations and caveats: The 100-206 trial was an open-label, dose-escalation safety run-in for what was originally planned as a larger randomized trial. 19 pts were enrolled to ensure that at least 8 pts completed the FDA-specified 24-mo. exposure period. At its Q3 2019 meeting, the DSMB found no adverse safety signal and recommended the trial continue as planned. However, the Sponsor did not have resources to fully support the randomized phase of the study and enrollment in the randomized phase was suspended.
Clinical trial NCT02880956: A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease
Official title: A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 453.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-01-26
Primary completion date: 2021-03-30
Completion date: 2021-07-28
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 and 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, please refer to the link below.
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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT03982186: A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
Official title: A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
Acronym: REEF-1
Sponsor: Janssen Sciences Ireland UC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 471.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-08-01
Primary completion date: 2021-03-29
Completion date: 2022-04-26
Baseline population: Intent to treat (ITT) set included all participants who were randomly assigned to any of the 6 intervention arms and received at least 1 dose of study intervention.
Plan to share individual participant data: YES
IPD sharing description: 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