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



Status:Recruiting
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2015
End Date:April 2017
Contact:Mindie H Nguyen, MD, MAS
Email:mindiehn@stanford.edu
Phone:650-498-5691

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Comparative Efficacy of Fixed-dose Combination of Sofosbuvir and Ledipasvir for 8 or 12 Weeks for 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

The secondary objective of this study is to describe safety, persistency, and tolerability
of SOF/LED in patients with HCV-6.

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)
We found this trial at
4
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Plano, Texas 75093
Phone: 972-398-0393
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Houston, Texas 77072
Phone: 281-983-0205
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Palo Alto, California 94304
Phone: 650-498-5691
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San Jose, California 95116
Phone: 408-347-9001
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