CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 205 enrolled
Drug / intervention
VOX +2 moredrug
Likely dose
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/NCT02378935
NCT02378935Phase 2Completed
CompareCT.gov

A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Genotype 1 HCV Infection

Gilead Sciences·interventional·Posted Mar 4, 2015·Updated Mar 6, 2020

In Brief

A Phase 2 clinical trial evaluating VOX, SOF/VEL, and 1 other intervention for Hepatitis C Virus Infection. Completed, enrolled 205 participants across 34 sites in 3 countries.

Detailed Summary

This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesNew Zealand, Puerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 4, 2015
Enrollment StartFeb 17, 2015
Primary CompletionFeb 1, 2016
Study CompletionApr 12, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.3 years ago

Interventions

VOXdrug

100 mg tablet(s) administered orally once daily with food

SOF/VELdrug

400/100 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 (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)