chufangao/CTO huggingface dataset:
Clinical trial NCT04075721: First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone
Official title: A Phase I Open Label First in Human Dose Escalation of the Immunoproteasome Inhibitor M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone in Participants With Relapsed Refractory Multiple Myeloma
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was early discontinued due to lack of participant enrollment.
Enrollment: 10.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-09-26
Primary completion date: 2021-04-01
Completion date: 2021-04-01
Baseline population: Safety analysis set included all participants who were administered any dose of the study medication.
Limitations and caveats: Part B was not conducted as the study was early discontinued due to lack of participant's recruitment into Part A before Part A reached its primary objective.
Plan to share individual participant data: NO
IPD sharing description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21
Clinical trial NCT05710146: Tranexamic Acid (TXA) in Hip Arthroscopy
Official title: Assessing the Efficacy of Tranexamic Acid (TXA) in Hip Arthroscopy: A Randomized, Controlled Trial
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Study was never started. Did not receive funding.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-12-31
Primary completion date: 2024-03-31
Completion date: 2024-09-30
Clinical trial NCT05197075: A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children
Official title: A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children Aged >=3 Years and Weighing >=15 kg to <25 kg
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-03
Primary completion date: 2022-09-23
Completion date: 2022-09-23
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
Clinical trial NCT04496167: Safety and Efficacy of EN3835 in Participants With Frozen Shoulder
Official title: A Phase 2, Randomized, Double Blind, Placebo Controlled Study of the Safety and Efficacy of EN3835 for the Treatment of Adhesive Capsulitis of the Shoulder
Sponsor: Endo Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 198.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-29
Primary completion date: 2022-04-14
Completion date: 2022-04-14
Baseline population: All randomized participants who received at least 1 injection of study treatment.
Plan to share individual participant data: YES
Clinical trial NCT04324463: Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial
Official title: Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial
Acronym: ACTCOVID19
Sponsor: Population Health Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 6667.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-04-21
Primary completion date: 2022-12-30
Completion date: 2022-12-30
Plan to share individual participant data: NO
Clinical trial NCT04002635: Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS)
Official title: Endometrial Preparation Using Letrozole Compared to Artificial Cycle for Frozen Embryo Transfer in PCOS Patients
Acronym: LEFT
Sponsor: CRG UZ Brussel (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Practical issues
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-01
Primary completion date: 2021-04-01
Completion date: 2022-04-01
Plan to share individual participant data: YES
IPD sharing description: Sharing with other study site, UZ Gent
Clinical trial NCT03359681: Metformin Treatment for Colon Cancer
Official title: Perioperative Metformin Treatment for Colon Cancer, a Randomized Trial
Acronym: MECORA
Sponsor: Zealand University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 48.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-10
Primary completion date: 2021-09-02
Completion date: 2021-10-04
Plan to share individual participant data: NO
Clinical trial NCT04404140: A Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Official title: A Phase Ib, Open-Label, Multicenter Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer.
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Despite many risk-minimization strategies, the combination of ipatasertib, atezolizumab and docetaxel was challenging due to multiple study treatment modifications required to manage toxicity, making further enrollment inappropriate.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-09
Primary completion date: 2022-10-14
Completion date: 2022-10-14
Clinical trial NCT03436121: Single-dose Ketamine for the Reduction of Pain and Depression in the Emergency Department
Official title: Single-dose Ketamine to Reduce Pain Severity, Depressive Symptoms and the Need for Opiates Both During and After Emergency Department Care
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Ketamine shortage during the funding period of the trial
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-31
Primary completion date: 2020-02-05
Completion date: 2020-02-05
Plan to share individual participant data: UNDECIDED
IPD sharing description: There is no plan in place yet because it is undecided whether the investigators will need to share the data with additional investigators/researchers not listed on the protocol.
Clinical trial NCT04447820: Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR
Official title: A Multicenter, Randomized, Open-Label, 4-Week Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Once Daily Treatment Compared to K-877-IR Twice Daily Treatment in Adult Patients With Fasting Triglyceride Levels
Sponsor: Kowa Research Institute, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 96.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-06-10
Primary completion date: 2020-12-03
Completion date: 2020-12-03
Baseline population: The Full Analysis Set (FAS) was defined as all randomized patients who took at least 1 dose of study drug and had a baseline fasting TG assessment.
Clinical trial NCT02266329: Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin
Official title: Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 89.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-04
Primary completion date: 2023-05-31
Completion date: 2023-09-30
Limitations and caveats: Change from baseline in headache (HA) frequency (1. Primary Outcome Measure) is based on linear mixed effects regression of outcome on study visit by treatment interaction with study participant as a random effect.
Plan to share individual participant data: NO
Clinical trial NCT05994547: Efficacy and Safety of Remimazolam Compared With Midazolam During Bronchoscopy:Randomised Controlled Trial
Official title: Safety and Efficacy of Remimazolam Compared With Midazolam During Bronchoscopy: A Single Center, Randomized Controlled Study
Sponsor: Chungbuk National University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 100.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-14
Primary completion date: 2023-06-15
Completion date: 2023-06-15
Clinical trial NCT03056040: ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
Official title: A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 202.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-17
Primary completion date: 2022-04-08
Completion date: 2022-04-08
Baseline population: All participants who received at least 1 dose of study treatment (ravulizumab or eculizumab).
Clinical trial NCT04193293: A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer
Official title: A Phase 1b/2 Study of Duvelisib in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Cancer
Sponsor: SecuraBio (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study was terminated due to low enrollment.
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-01
Primary completion date: 2020-12-10
Completion date: 2020-12-10
Baseline population: This study was terminated by the Sponsor. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.
Limitations and caveats: The study was terminated early by the Sponsor due to low enrollment. Due to study termination and only 2 participants receiving treatment, there are concerns regarding participant confidentiality, therefore no data are being reported.
Clinical trial NCT03283826: Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis
Official title: A Phase 1/2, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study With an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis
Acronym: EMBOLD
Sponsor: Atara Biotherapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study was terminated as primary endpoint was not achieved
Enrollment: 134.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-19
Primary completion date: 2023-11-09
Completion date: 2024-01-17
Plan to share individual participant data: NO
Clinical trial NCT04753957: Pharmacokinetics of Progesterone in Pregnancy-2
Official title: Pharmacokinetics of Progesterone in Pregnancy-2
Acronym: PiP-2
Sponsor: Thomas Jefferson University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Difficulty with endometrial sample collection. New study design to be prospective observational to validate reliable methods of endometrial sampling at time of c-section.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-07
Primary completion date: 2022-02-01
Completion date: 2022-02-01
Plan to share individual participant data: YES
IPD sharing description: IPD may be requested following trial completion and publication with appropriate data sharing agreement.
IPD time frame: Following trial completion and publication
IPD access criteria: Data sharing agreement
Clinical trial NCT06029530: Delaying the Onset of Nearsightedness Until Treatment Study
Official title: Delaying the Onset of Nearsightedness Until Treatment Study
Acronym: DONUT
Sponsor: Ohio State University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: sIRB determined feasibility study could not be done because of no benefits of the treatment drops in short time violated FDA requirements
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2024-01-01
Primary completion date: 2024-08-31
Completion date: 2024-08-31
Plan to share individual participant data: NO
Clinical trial NCT03666442: Early Evaluation of Chemosensitivity for Low/Intermediated-risk Mid-low Stage II/III Rectal Cancer
Official title: Early Evaluation of Chemosensitivity for Low-risk Stage II/III Rectal Cancer
Sponsor: West China Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 61.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-01
Primary completion date: 2020-01-01
Completion date: 2022-01-01
Plan to share individual participant data: NO
Clinical trial NCT04349774: Erector Spinae Plane Block vs Erector Spinae Plane Block With Serratus Anterior Plane Block in Thoracic Surgery
Official title: A Prospective, Randomized, Double-Blind, Active-Comparator, Pilot Study to Observe Relative Efficacy of Ultrasound-Guided Erector Spinae Plane Block (ESP) vs. Combination of Ultrasound - Guided Erector Spinae Plane Block With Serratus Anterior Plane Block in Managing Post-operative Pain Following Thoracic Surgery.
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Study was never initiated due to COVID-19
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-01
Primary completion date: 2023-06-01
Completion date: 2023-12-30
Plan to share individual participant data: NO
Clinical trial NCT05222165: Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations
Official title: A Phase 1b/2, Multicenter, Open-Label Study of Oral Infigratinib in Pediatric Subjects With Advanced Solid and Central Nervous System (CNS) Tumors (Phase 1b) and in Subjects With Recurrent or Progressive Low-Grade Gliomas Harboring Selected FGFR1, FGFR2, or FGFR3 Alterations (Phase 2)
Acronym: NEWEL
Sponsor: Helsinn Healthcare SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: The company decided to interrupt the development of the drug in all oncological indications
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-01
Primary completion date: 2022-12-16
Completion date: 2022-12-16
Plan to share individual participant data: NO
Clinical trial NCT03569098: Dysport in Hallux Abducto Valgus (HAV) Phase IIa
Official title: A Multiple-dose, Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dysport for the Treatment of Pain Associated With Hallux Abducto Valgus
Acronym: DYSTANCE
Sponsor: Ipsen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 186.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-06-19
Primary completion date: 2019-12-17
Completion date: 2020-05-22
Baseline population: The Intention-to-Treat (ITT) analysis set included all randomized participants.
Limitations and caveats: Based on the results of the primary analysis the sponsor terminated the study early due to lack of efficacy of the tested doses at the primary endpoint. The decision by the sponsor to terminate the study early was not related to any safety or tolerability concerns with Dysport.
Clinical trial NCT04417036: This Study Collects Information on the Safety of Inhaled Pegylated Adrenomedullin (PEG-ADM), How the Drug is Tolerated and How it Affects Patients Suffering From a Type of Lung Failure That Cause Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)
Official title: Safety and Efficacy of Inhaled Pegylated Adrenomedullin (PEG-ADM) in Patients Suffering From Acute Respiratory Distress Syndrome (ARDS): a Double-blind, Randomized, Placebo-controlled, Multicenter Phase 2a/b Clinical Trial
Acronym: SEAL
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated (based on Part A results, Bayer decided to not continue investigating BAY 1097761 further in Part B; this was not due to any safety data for BAY 1097761)
Enrollment: 90.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-07-07
Primary completion date: 2022-12-28
Completion date: 2022-12-28
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later 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.vivli.org 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 member section of the portal.
Clinical trial NCT03127592: Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction
Official title: Phase III Randomized, Unicentric, Double-masked, Parallel Trial for the Efficacy and Tolerability of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus the Isolated Active Substances (Flancox® 400 mg And Miosan® 10 mg) in Postoperative Pain Control After Impacted Third Molar Extraction
Acronym: FDCETCB-III
Sponsor: Apsen Farmaceutica S.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: recruitment difficulty
Enrollment: 140.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-10-05
Primary completion date: 2022-07-26
Completion date: 2022-07-26
Plan to share individual participant data: NO
Clinical trial NCT01618695: A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Official title: A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Sponsor: Eisai Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 940.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-05-15
Primary completion date: 2014-09-15
Completion date: 2020-05-28
Baseline population: Safety Analysis Set (SAS) included all participants who signed informed consent, were randomized, received at least one dose of study medication, and had at least one post-dose safety assessment.
Clinical trial NCT03428217: CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)
Acronym: CANTATA
Sponsor: Calithera Biosciences, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 444.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-24
Primary completion date: 2020-08-31
Completion date: 2021-07-16
Plan to share individual participant data: NO
Clinical trial NCT04775329: Primary Prophylaxis for Spontaneous Bacterial Peritonitis
Official title: Primary Prophylaxis for Spontaneous Bacterial Peritonitis in Decompensated Chronic Liver Disease With Small Bowel Bacterial Overgrowth: A Randomised Trial
Acronym: SIBOC
Sponsor: Changi General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Slow recruitment and study closure
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-01
Primary completion date: 2023-01-01
Completion date: 2023-01-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04285229: A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis
Official title: A Multicenter, Randomized, Double-Blind and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Chinese Patients With Radiographic Axial Spondyloarthritis
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 147.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-10
Primary completion date: 2021-03-31
Completion date: 2022-03-17
Baseline population: All randomized participants
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT01815736: Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants
Official title: A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1443.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-03-27
Primary completion date: 2015-03-16
Completion date: 2020-04-01
Baseline population: Safety Analysis Set included participants who were randomized and received at least one dose of study drug.
Limitations and caveats: There were no limitations affecting the analysis or results.
Plan to share individual participant data: YES
IPD sharing description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
IPD time frame: 18 months after study completion
IPD access criteria: A secured external environment with username, password, and RSA code.