At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 375 enrolled
Drug / intervention
SOF/VELdrug
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, Open-Label 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 for Hepatitis C Virus Infection. Completed, enrolled 375 participants across 38 sites in 5 countries.
Detailed Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesChina, Malaysia, Singapore, Thailand, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartApr 2016
Primary CompletionJan 2018
Study CompletionMar 2018
TodayJul 2026
First PostedFeb 2, 2016
Enrollment StartApr 19, 2016
Primary CompletionJan 5, 2018
Study CompletionMar 27, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.4 years ago
Interventions
SOF/VELdrug
SOF/VEL (400/100 mg) FDC tablet administered orally once daily