CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 87 enrolled
Drug / intervention
SOF/VEL +1 moredrug
Likely dose
SOF/VEL 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/NCT04211909
NCT04211909Phase 3Completed

A Phase 3b Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection

Gilead Sciences·interventional·Posted Dec 26, 2019·Updated Oct 27, 2021

In Brief

A Phase 3 clinical trial evaluating SOF/VEL and SOF/VEL/VOX for Hepatitis C Virus Infection. Completed, enrolled 87 participants across 22 sites.

Detailed Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 26, 2019
Enrollment StartJan 3, 2020
Primary CompletionNov 12, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.5 years ago

Interventions

SOF/VELdrug

400/100 mg FDC tablet orally once daily.

SOF/VEL/VOXdrug

400/100/100 mg FDC tablet orally once daily.