At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 220 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/NCT02639338

NCT02639338Phase 3Completed

Compare CT.gov

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 and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis

Gilead Sciences·interventional·Posted Dec 24, 2015·Updated Mar 5, 2019

In Brief

A Phase 3 clinical trial evaluating SOF/VEL/VOX and SOF/VEL for Hepatitis C Virus Infection. Completed, enrolled 220 participants across 70 sites in 8 countries.

Detailed Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis C Virus Infection

CountriesAustralia, Canada, France, Germany, New Zealand, Puerto Rico, United Kingdom, United States

Collaborators--

Timeline

Phase 3CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartDec 2015

First PostedDec 2015

Primary CompletionOct 2016

Study CompletionJan 2017

TodayJul 2026

First PostedDec 24, 2015

Enrollment StartDec 23, 2015

Primary CompletionOct 12, 2016

Study CompletionJan 2, 2017

TodayJul 2, 2026

Enrollment to primary: 10 monthsPosted 10.5 years ago

Interventions

SOF/VEL/VOXdrug

400/100/100 mg FDC tablet administered orally once daily with food

SOF/VELdrug

400/100 mg FDC tablet administered orally once daily without regard to food