CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 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/NCT02994056
NCT02994056Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis

Gilead Sciences·interventional·Posted Dec 15, 2016·Updated Mar 2, 2020

In Brief

A Phase 2 clinical trial evaluating SOF/VEL and RBV for Hepatitis C Virus Infection. Completed, enrolled 32 participants across 12 sites in 2 countries.

Detailed Summary

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

Study Details

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

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 15, 2016
Enrollment StartJan 23, 2017
Primary CompletionSep 25, 2018
Study CompletionDec 12, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.5 years ago

Interventions

SOF/VELdrug

400/100 mg FDC tablet administered orally once daily

RBVdrug

Tablets administered orally at 600 mg, if well tolerated then up to a maximum total daily dose of 1000 to 1200 mg (based on weight) divided twice daily.