CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 101 enrolled
Drug / intervention
LDV/SOF +2 moredrug
Likely dose
LDV/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/NCT01984294
NCT01984294Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination With Ribavirin or GS-9669 250 mg or GS-9669 500 mg in Naive or Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection

Gilead Sciences·interventional·Posted Nov 14, 2013·Updated Nov 19, 2018

In Brief

A Phase 2 clinical trial evaluating LDV/SOF, RBV, and 1 other intervention for Chronic HCV Infection. Completed, enrolled 101 participants across 1 site.

Detailed Summary

This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment, approximately 60 having had prior treatment with a regimen containing pegylated interferon (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus treatment-experienced and by HCV genotype (1a versus 1b).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic HCV Infection
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 14, 2013
Enrollment StartOct 1, 2013
Primary CompletionApr 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.6 years ago

Interventions

LDV/SOFdrug

Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet administered orally once daily

RBVdrug

Ribavirin (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)

GS-9669drug

GS-9669 tablet(s) administered orally once daily