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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Able to provide written informed consent

• Chronic genotype 1 and/or 4 HCV infection

• Normal ECG

• Negative serum pregnancy test for female subjects

• Male subjects and female subjects of childbearing potential must agree to use contraception

• Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits

Exclusion Criteria:

• Serious or active medical or psychiatric illness

• HIV or hepatitis B viral (HBV) infection

• Stomach disorder that could interfere with the absorption of the study drug

• Treated with an anti-HCV medication in the last 30 days

• Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor

• Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening

• History of clinically significant medical condition associated with other chronic liver disease

• Active spontaneous bacterial peritonitis at screening

• Females who are breastfeeding

• Infection requiring systemic antibiotics

• Participated in a clinical study with an investigational drug or biologic within the last 30 days

• Active or history (last 6 months) of drug or alcohol abuse

• History of organ transplant other than liver, kidney, or corneal.