CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
SOF +2 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.

Search/NCT01808248
NCT01808248Phase 2Completed
CompareCT.gov

A Phase 2, Open-Label Study of Sofosbuvir in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3

Gilead Sciences·interventional·Posted Mar 11, 2013·Updated Sep 12, 2014

In Brief

A Phase 2 clinical trial evaluating SOF, PEG, and 1 other intervention for Hepatitis C. Completed, enrolled 47 participants across 1 site.

Detailed Summary

This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2013
Enrollment StartFeb 1, 2013
Primary CompletionSep 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.3 years ago

Interventions

SOFdrug

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

PEGdrug

Peginterferon alfa 2a (PEG) 180 μg administered once weekly by subcutaneous injection

RBVdrug

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)