CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 269 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/NCT02220998
NCT02220998Phase 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 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

Gilead Sciences·interventional·Posted Aug 20, 2014·Updated Nov 15, 2018

In Brief

A Phase 3 clinical trial evaluating SOF/VEL, SOF, and 1 other intervention for Hepatitis C Virus Infection. Completed, enrolled 269 participants across 51 sites in 2 countries.

Detailed Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 20, 2014
Enrollment StartSep 1, 2014
Primary CompletionJul 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.9 years ago

Interventions

SOF/VELdrug

SOF/VEL (400/100 mg) FDC tablet administered orally once daily

SOFdrug

SOF 400 mg tablet administered orally once daily

RBVdrug

RBV 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)