CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 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.

Search/NCT01687270
NCT01687270Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant

Gilead Sciences·interventional·Posted Sep 18, 2012·Updated Dec 19, 2014

In Brief

A Phase 2 clinical trial evaluating Sofosbuvir and RBV for Recurrent Chronic Hepatitis C Virus and Post Liver Transplant. Completed, enrolled 40 participants across 12 sites in 5 countries.

Detailed Summary

This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Chronic Hepatitis C Virus, Post Liver Transplant
CountriesFrance, Germany, New Zealand, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2012
Enrollment StartNov 1, 2012
Primary CompletionDec 1, 2013
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.8 years ago

Interventions

Sofosbuvirdrug

Sofosbuvir 400 mg tablet administered orally once daily

RBVdrug

Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight.