CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 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/NCT02226549
NCT02226549Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection and Cirrhosis

Gilead Sciences·interventional·Posted Aug 27, 2014·Updated Nov 16, 2018

In Brief

A Phase 2 clinical trial evaluating LDV/SOF, VDV, and 1 other intervention for Hepatitis C Virus Infection. Completed, enrolled 47 participants across 1 site.

Detailed Summary

This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 27, 2014
Enrollment StartJul 1, 2014
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.8 years ago

Interventions

LDV/SOFdrug

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

VDVdrug

VDV 80 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)