At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 37 enrolled
Drug / intervention
SOF/VELdrug
Likely dose
Not stated in 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.
A Phase 3 Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection and Compensated Cirrhosis
In Brief
A Phase 3 clinical trial evaluating SOF/VEL for Hepatitis C Virus Infection. Completed, enrolled 37 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) in adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartOct 2019
Primary CompletionMar 2021
Study CompletionJun 2021
TodayJul 2026
First PostedOct 2, 2019
Enrollment StartOct 16, 2019
Primary CompletionMar 26, 2021
Study CompletionJun 25, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.8 years ago
Interventions
SOF/VELdrug
Tablets administered orally once daily