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



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:11/18/2018
Start Date:September 2013
End Date:March 2015

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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

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.


Inclusion Criteria:

- 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

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 or kidney
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