CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 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.

Search/NCT01687257
NCT01687257Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Open-Label, Randomized Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin Administered for 48 Weeks in Patients Infected With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation

Gilead Sciences·interventional·Posted Sep 18, 2012·Updated Sep 16, 2016

In Brief

A Phase 2 clinical trial evaluating SOF and RBV for Hepatitis C and 3 related conditions. Completed, enrolled 50 participants across 9 sites in 5 countries.

Detailed Summary

This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Cirrhosis, Portal Hypertension, With or Without Liver Decompensation
CountriesAustralia, France, New Zealand, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2012
Enrollment StartJul 1, 2012
Primary CompletionJan 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.8 years ago

Interventions

SOFdrug

SOF 400 mg tablet administered orally once daily

RBVdrug

RBV 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)