Overview

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

Status:
Completed

Trial end date:
2015-02-01

Target enrollment:

Participant gender:

Summary

This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.

Phase:

Phase 2

Details

Lead Sponsor:

Gilead Sciences

Treatments:

Ledipasvir
Ledipasvir, sofosbuvir drug combination
Sofosbuvir