CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 101 enrolled
Drug / intervention
Voxilaprevir +2 moredrug
Likely dose
SOF/VEL 400 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/NCT02185794
NCT02185794Phase 1Completed
CompareCT.gov

Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-9857 in Subjects With Chronic Hepatitis C Virus Infection

Gilead Sciences·interventional·Posted Jul 10, 2014·Updated Sep 17, 2020

In Brief

A Phase 1 clinical trial evaluating Voxilaprevir, Placebo to match voxilaprevir, and 1 other intervention for Hepatitis C Virus Infection. Completed, enrolled 101 participants across 11 sites in 2 countries.

Detailed Summary

The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.

Study Details

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

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 10, 2014
Enrollment StartJun 13, 2014
Primary CompletionDec 22, 2014
Study CompletionSep 28, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.0 years ago

Interventions

Voxilaprevirdrug

Voxilaprevir tablets administered orally once daily

Placebo to match voxilaprevirdrug

Placebo to match voxilaprevir tablets administered orally once daily

SOF/VELdrug

400 mg/100 mg FDC tablet administered orally once daily