At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 127 enrolled
Drug / intervention
SOF +1 moredrug
Likely dose
SOF 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, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Genotype 1 and 3 Chronic HCV Infection.
In Brief
A Phase 3 clinical trial evaluating SOF and RBV for Hepatitis C. Completed, enrolled 127 participants across 16 sites.
Detailed Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesRussia
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedJul 2013
Primary CompletionApr 2014
Study CompletionJun 2014
TodayJul 2026
First PostedJul 11, 2013
Enrollment StartJun 1, 2013
Primary CompletionApr 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.0 years ago
Interventions
SOFdrug
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBVdrug
Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)