Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/17/2018 |
Start Date: | July 2014 |
End Date: | September 2015 |
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with
chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.
of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with
chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.
Inclusion Criteria:
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central
laboratory
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
- Classification as treatment naive or treatment experienced
- Males and females of childbearing potential who engage in heterosexual intercourse
must agree to use protocol specified method(s) of contraception
Exclusion Criteria:
- Current or prior history of clinically-significant illness (other than HCV) or any
other major medical disorder that may interfere with treatment, assessment, or
compliance with the protocol; individuals currently under evaluation for a potentially
clinically-significant illness (other than HCV) are also excluded.
- Screening ECG with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at Screening
- Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A
inhibitor
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
We found this trial at
46
sites
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