CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
LDV/SOF +1 moredrug
Likely dose
RBV 1000 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/NCT01987453
NCT01987453Phase 2Completed
CompareCT.gov

An Open-Label, Multicenter Study To Evaluate The Efficacy And Safety Of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin For 12 or 24 Weeks In Chronic Genotype 1 HCV Infected Subjects Who Participated In A Prior Gilead-Sponsored HCV Treatment Study

Gilead Sciences·interventional·Posted Nov 19, 2013·Updated Nov 19, 2018

In Brief

A Phase 2 clinical trial evaluating LDV/SOF and RBV for HCV Infection. Completed, enrolled 100 participants across 43 sites in 5 countries.

Detailed Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA \< lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHCV Infection
CountriesAustralia, France, Puerto Rico, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 19, 2013
Enrollment StartJul 1, 2014
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.6 years ago

Interventions

LDV/SOFdrug

Tablet(s) administered orally once daily

RBVdrug

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) Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert.