CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 128 enrolled
Drug / intervention
VOX +1 moredrug
Likely dose
VOX 100 mg orally once daily with food plus SOF/VEL 400/100 mg orally once daily with foodAI-extracted
Key inclusion· 5
  • ✓Confirmed chronic HCV infection
  • ✓HCV RNA viral load ≥10^4 IU/mL at screening
  • ✓HCV genotype 2, 3, 4, 5, or 6 (non-genotype 1)
  • ✓Cirrhosis status determined; liver biopsy may be required
Key exclusion· 5
  • ✕Pregnant or nursing female
  • ✕Prior or current hepatic decompensation
  • ✕Hepatocellular carcinoma (HCC) or other clinically significant malignancy
  • ✕HBV or HIV coinfection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02378961
NCT02378961Phase 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 Non-Genotype 1 HCV Infection

Gilead Sciences·interventional·Posted Mar 4, 2015·Updated Mar 3, 2020

In Brief

A Phase 2 clinical trial evaluating VOX and SOF/VEL for Hepatitis C Virus Infection. Completed, enrolled 128 participants across 34 sites in 3 countries.

Detailed Summary

The 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) in adults with chronic non 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 16, 2015
Primary CompletionSep 21, 2015
Study CompletionJan 26, 2016
TodayJul 2, 2026
Enrollment to primary: 7 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