CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 31 enrolled
Drug / intervention
SOF/VEL/VOXdrug
Likely dose
Sofosbuvir/velpatasvir/voxilaprevir 400/100/100 mg orally once daily with foodAI-extracted
Key inclusion· 3
  • Chronic HCV infection documented in a prior Gilead-sponsored HCV treatment study
  • Age 18 years or older
  • Did not achieve sustained virologic response (SVR) in a prior Gilead-sponsored HCV treatment study
Key exclusion· 0

None specified.

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

Search/NCT03118843
NCT03118843Phase 3Completed

An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

Gilead Sciences·interventional·Posted Apr 18, 2017·Updated Apr 3, 2019

In Brief

A Phase 3 clinical trial evaluating SOF/VEL/VOX for Hepatitis C Virus Infection. Completed, enrolled 31 participants across 27 sites in 7 countries.

Detailed Summary

The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, France, Germany, New Zealand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 18, 2017
Enrollment StartApr 25, 2017
Primary CompletionMar 19, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.2 years ago

Interventions

SOF/VEL/VOXdrug

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