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Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

Chronic HCV Infection Clinical Trial

Official title:
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant

Clinical Trial Summary

This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection.

- Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;

- Cohort B: post-liver transplant, with or without cirrhosis;

- Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups)

- Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02010255
Study type Interventional
Source Gilead Sciences
Contact
Status Completed
Phase Phase 2
Start date January 2014
Completion date August 2015
View Details
See also
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