NCT02010255

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic HCV Infection

Interventions

Type	Name	Description
DRUG	LDV/SOF	LDV/SOF FDC tablet administered orally once daily
DRUG	RBV	RBV tablets administered orally in a divided daily dose

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-05-01
• Completion: 2015-08-01
• First posted: 2013-12-12
• Last updated: 2018-11-19
• Results posted: 2016-06-20

Locations

34 sites across 12 countries: Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, New Zealand, Spain, Switzerland, United Kingdom