CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
LDV/SOF +1 moredrug
Likely dose
LDV/SOF 90 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/NCT01726517
NCT01726517Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Infection

Gilead Sciences·interventional·Posted Nov 15, 2012·Updated Nov 16, 2018

In Brief

A Phase 2 clinical trial evaluating LDV/SOF and RBV for Chronic Hepatitis C Virus. Completed, enrolled 100 participants across 1 site.

Detailed Summary

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Virus
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 15, 2012
Enrollment StartOct 1, 2012
Primary CompletionJul 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.6 years ago

Interventions

LDV/SOFdrug

LDV 90 mg/SOF 400 mg FDC 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)