Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6
Completed · Phase 4
Conditions studied: PT-NANBH
In brief
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
Key facts
- Study ID
- NCT02480166
- Run by
- Stanford University
- People needed
- 60
- Starts
- 2015-06-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2017-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female, age ≥18 years
- HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6
- Selected to start on treatment by their treating providers
- Willing and able to provide informed consent
- Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments
- Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline
- Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- Lactating females must agree to discontinue nursing before the study drug is administered
You may not qualify if…
- Previous recipient of a liver transplant
- Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)
Where it is running
- Stanford University Medical Center — Palo Alto, California, United States
- San Jose Gastroenterology — San Jose, California, United States
- Liver and Digestive Consultants — Houston, Texas, United States
- Digestive Health Associates — Plano, Texas, United States
Full record on ClinicalTrials.gov
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