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

Location:

Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

The purpose of this study is to evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 1 or 4 hepatitis C virus (HCV) infection. Participants will be randomized to receive 12 or 24 weeks of dosing with the LDV/SOF FDC tablet+ribavirin (RBV).

Who is eligible to participate?

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

Last updated:

5/15/2014

NCT ID:

NCT01938430

IRB Number:

13-007509