At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 102 enrolled
Drug / intervention
SOF/VEL +1 moredrug
Likely dose
Sofosbuvir/velpatasvir 400/100 mg orally once daily ± ribavirin for 12 weeksAI-extracted
Key inclusion· 3
- ✓Chronic HCV infection confirmed
- ✓Treatment-naive or treatment-experienced
- ✓Decompensated cirrhosis with Child-Pugh score 7–12
Key exclusion· 0
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Decompensated Cirrhosis
In Brief
A Phase 3 clinical trial evaluating SOF/VEL and RBV for Hepatitis C Virus Infection. Completed, enrolled 102 participants across 33 sites.
Detailed Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartDec 2016
Primary CompletionFeb 2018
Study CompletionMay 2018
TodayJul 2026
First PostedDec 19, 2016
Enrollment StartDec 26, 2016
Primary CompletionFeb 13, 2018
Study CompletionMay 8, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.5 years ago
Interventions
SOF/VELdrug
400/100 mg FDC tablet administered orally once daily
RBVdrug
Capsules administered orally in a divided daily dose