At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 111 enrolled
Drug / intervention
SOF/VELdrug
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.
An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection
In Brief
A Phase 3 clinical trial evaluating SOF/VEL for Hepatitis C Virus Infection. Completed, enrolled 111 participants across 61 sites in 9 countries.
Detailed Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesBelgium, Canada, France, Germany, Hong Kong, Italy, Puerto Rico, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartFeb 2015
Primary CompletionMar 2016
Study CompletionJun 2016
TodayJul 2026
First PostedJan 27, 2015
Enrollment StartFeb 23, 2015
Primary CompletionMar 23, 2016
Study CompletionJun 15, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.4 years ago
Interventions
SOF/VELdrug
400/100 mg tablet administered orally once daily