CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
SOF/VEL/VOX +1 moredrug
Likely dose
SOF/VEL/VOX 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/NCT02536313
NCT02536313Phase 2Completed
CompareCT.gov

A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/GS-5816/GS-9857 Fixed-Dose Combination With or Without Ribavirin in Subjects With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

Gilead Sciences·interventional·Posted Aug 31, 2015·Updated Feb 25, 2019

In Brief

A Phase 2 clinical trial evaluating SOF/VEL/VOX and RBV for Hepatitis C Virus Infection. Completed, enrolled 49 participants across 1 site.

Detailed Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 31, 2015
Enrollment StartJul 29, 2015
Primary CompletionMar 28, 2016
Study CompletionJun 28, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.8 years ago

Interventions

SOF/VEL/VOXdrug

400/100/100 mg FDC tablet administered orally once daily with food

RBVdrug

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)