CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 204 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/NCT02781558
NCT02781558Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis

Gilead Sciences·interventional·Posted May 24, 2016·Updated Nov 27, 2018

In Brief

A Phase 2 clinical trial evaluating SOF/VEL and RBV for Hepatitis C Virus Infection. Completed, enrolled 204 participants across 28 sites.

Detailed Summary

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

Study Details

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

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 24, 2016
Enrollment StartJul 29, 2016
Primary CompletionOct 6, 2017
Study CompletionOct 27, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.1 years ago

Interventions

SOF/VELdrug

400/100 mg FDC 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)