At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 103 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 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection.
In Brief
A Phase 3 clinical trial evaluating SOF and RBV for Hepatitis C Virus. Completed, enrolled 103 participants across 2 sites.
Detailed Summary
This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus
CountriesEgypt
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2013
First PostedApr 2013
Primary CompletionMay 2014
Study CompletionAug 2014
TodayJul 2026
First PostedApr 24, 2013
Enrollment StartMar 1, 2013
Primary CompletionMay 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.2 years ago
Interventions
SOFdrug
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBVdrug
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)