CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 323 enrolled
Drug / intervention
SOF +2 moredrug
Likely dose
SOF 400 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/NCT01909804
NCT01909804Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection

Gilead Sciences·interventional·Posted Jul 29, 2013·Updated Nov 15, 2018

In Brief

A Phase 2 clinical trial evaluating SOF, VEL, and 1 other intervention for Hepatitis C. Completed, enrolled 323 participants across 49 sites in 4 countries.

Detailed Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesAustralia, New Zealand, Puerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 29, 2013
Enrollment StartJun 1, 2013
Primary CompletionMay 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.9 years ago

Interventions

SOFdrug

400 mg tablet administered orally once daily

VELdrug

Tablet administered orally once daily

RBVdrug

200 mg 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)