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

Trial ID or NCT#

NCT02480166

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Male or female, age ≥18 years2. HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 63. Selected to start on treatment by their treating providers4. Willing and able to provide informed consent5. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments6. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception8. Lactating females must agree to discontinue nursing before the study drug is administered
Exclusion Criteria:
  1. 1. Previous recipient of a liver transplant2. Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)
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Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Hepatologist, Transplant hepatologist
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health

Contact us to find out if this trial is right for you.

Contact

Mindie H Nguyen, MD, MAS
650-498-5691

View on ClinicalTrials.gov