At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 117 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, Multi-Center, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Chronic Genotype 1 or 3 Hepatitis C Virus Infection
In Brief
A Phase 3 clinical trial evaluating Sofosbuvir and RBV for Chronic HCV Infection. Completed, enrolled 117 participants across 13 sites.
Detailed Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus (HCV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic HCV Infection
CountriesIndia
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartMar 2014
Primary CompletionSep 2015
Study CompletionNov 2015
TodayJul 2026
First PostedFeb 28, 2014
Enrollment StartMar 1, 2014
Primary CompletionSep 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.3 years ago
Interventions
Sofosbuvirdrug
400 mg tablet administered orally once daily
RBVdrug
200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)