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
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?
- 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
- 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