CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 416 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.

Search/NCT02607735
NCT02607735Phase 3Completed
CompareCT.gov

A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection

Gilead Sciences·interventional·Posted Nov 18, 2015·Updated Mar 5, 2019

In Brief

A Phase 3 clinical trial evaluating SOF/VEL/VOX and Placebo for Hepatitis C. Completed, enrolled 416 participants across 86 sites in 8 countries.

Detailed Summary

The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy. Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.

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
First PostedNov 18, 2015
Enrollment StartNov 11, 2015
Primary CompletionOct 10, 2016
Study CompletionJun 21, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.6 years ago

Interventions

SOF/VEL/VOXdrug

400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food

Placebodrug

Tablet administered orally once daily with food