At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 153 enrolled
Drug / intervention
Sofosbuvir +1 moredrug
Likely dose
Sofosbuvir 400 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.
A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection
In Brief
A Phase 3 clinical trial evaluating Sofosbuvir and RBV for Hepatitis C. Completed, enrolled 153 participants across 19 sites.
Detailed Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2013
First PostedJul 2013
Primary CompletionMar 2014
Study CompletionJun 2014
TodayJul 2026
First PostedJul 29, 2013
Enrollment StartFeb 1, 2013
Primary CompletionMar 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.9 years ago
Interventions
Sofosbuvirdrug
Sofosbuvir 400 mg tablet administered orally once daily
RBVdrug
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing according to the approved Copegus labeling in Japan (\< 60 kg = 600 mg , \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)