At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 943 enrolled
Drug / intervention
SOF/VEL/VOX +1 moredrug
Likely dose
SOF/VEL/VOX 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, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects With Chronic HCV Infection
In Brief
A Phase 3 clinical trial evaluating SOF/VEL/VOX and SOF/VEL for Hepatitis C. Completed, enrolled 943 participants across 93 sites in 8 countries.
Detailed Summary
The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesAustralia, Canada, France, Germany, New Zealand, Puerto Rico, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartNov 2015
First PostedNov 2015
Primary CompletionOct 2016
Study CompletionJan 2017
TodayJul 2026
First PostedNov 18, 2015
Enrollment StartNov 16, 2015
Primary CompletionOct 10, 2016
Study CompletionJan 11, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.6 years ago
Interventions
SOF/VEL/VOXdrug
400/100/100 mg tablet administered orally once daily with food
SOF/VELdrug
400/100 mg tablet administered orally once daily with or without food