Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to describe the efficacy of:

1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6

2. 12-week treatment of SOF/LED for all other HCV-6 populations

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Gilead Sciences
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

Criteria

Inclusion Criteria:

1. Male or female, age ≥18 years

2. HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6

3. Selected to start on treatment by their treating providers

4. Willing and able to provide informed consent

5. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments

6. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline

7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

8. Lactating females must agree to discontinue nursing before the study drug is administered

Exclusion Criteria:

1. Previous recipient of a liver transplant

2. Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)