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Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6
Not Recruiting
Trial ID: NCT02480166
Purpose
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
Official Title
Comparative Efficacy of Fixed-dose Combination of Sofosbuvir and Ledipasvir for 8 or 12 Weeks for Chronic Hepatitis C Genotype 6
Stanford Investigator(s)
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
Eligibility
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)
Intervention(s):
drug: 8 weeks SOF/LED
drug: 12 weeks SOF/LED
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mindie H Nguyen, MD, MAS
650-498-5691