CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 333 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/NCT02639247
NCT02639247Phase 3Completed
CompareCT.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 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

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 333 participants across 78 sites in 8 countries.

Detailed Summary

The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.

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
First PostedDec 24, 2015
Enrollment StartDec 23, 2015
Primary CompletionOct 5, 2016
Study CompletionJan 18, 2017
TodayJul 2, 2026
Enrollment to primary: 9 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