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

Completed · Phase 2

Conditions studied: Chronic HCV Infection

In brief

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.

Key facts

Study ID

NCT01938430

Run by

Gilead Sciences

People needed

339

Starts

2013-09-01

Expected to finish

2015-03-01

Last updated by the study team

2018-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide written informed consent
• Chronic genotype 1 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

You may not qualify if…

• 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 or kidney

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Kansas City, Kansas, United States
• Study site — Lutherville, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Rochester, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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