CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 117 enrolled
Drug / intervention
SOF/VEL +1 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/NCT02822794
NCT02822794Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

Gilead Sciences·interventional·Posted Jul 4, 2016·Updated Nov 14, 2018

In Brief

A Phase 3 clinical trial evaluating SOF/VEL and RBV for Hepatitis C Virus Infection. Completed, enrolled 117 participants across 18 sites.

Detailed Summary

The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 4, 2016
Enrollment StartJul 25, 2016
Primary CompletionJun 2, 2017
Study CompletionAug 25, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.0 years ago

Interventions

SOF/VELdrug

400/100 mg tablet administered orally once daily

RBVdrug

Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)