CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 558 enrolled
Drug / intervention
SOF/VEL +2 moredrug
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.

Search/NCT02201953
NCT02201953Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection

Gilead Sciences·interventional·Posted Jul 28, 2014·Updated Nov 16, 2018

In Brief

A Phase 3 clinical trial evaluating SOF/VEL, SOF, and 1 other intervention for Hepatitis C Virus Infection. Completed, enrolled 558 participants across 76 sites in 9 countries.

Detailed Summary

The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesAustralia, Canada, France, Germany, Italy, New Zealand, Puerto Rico, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 28, 2014
Enrollment StartJul 1, 2014
Primary CompletionSep 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.9 years ago

Interventions

SOF/VELdrug

400/100 mg FDC tablet administered orally once daily

SOFdrug

400 mg tablet administered orally once daily

RBVdrug

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)