At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 741 enrolled
Drug / intervention
SOF/VEL +1 moredrug
Likely dose
SOF/VEL 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV
In Brief
A Phase 3 clinical trial evaluating SOF/VEL and Placebo for Hepatitis C Virus Infection. Completed, enrolled 741 participants across 80 sites in 9 countries.
Detailed Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesBelgium, Canada, China, France, Germany, Italy, Puerto Rico, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJul 2014
First PostedJul 2014
Primary CompletionJun 2015
Study CompletionSep 2015
TodayJul 2026
First PostedJul 28, 2014
Enrollment StartJul 1, 2014
Primary CompletionJun 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.9 years ago
Interventions
SOF/VELdrug
400/100 mg FDC tablet administered orally once daily
Placebodrug
Tablet administered orally once daily