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
Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials
