Trial Search Results

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

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Gilead Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: 8 weeks SOF/LED
  • Drug: 12 weeks SOF/LED

Phase:

Phase 4

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)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mindie H Nguyen, MD, MAS
650-498-5691
Not Recruiting