Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/18/2018 |
| Start Date: | December 1, 2014 |
| End Date: | September 15, 2016 |
An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who Participated In A Prior Gilead Sponsored HCV Treatment Study
The primary objective of this study is to evaluate the efficacy, safety and tolerability of
treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks
in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead
sponsored study and did not achieve sustained virologic response (SVR).
treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks
in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead
sponsored study and did not achieve sustained virologic response (SVR).
Key Inclusion Criteria:
- Willing and able to provide written informed consent
- HCV genotype determined by the Central Laboratory
- HCV RNA > LLOQ at screening
- Participated and completed a Gilead sponsored HCV treatment study of direct acting
antiviral (DAA) containing regimens.
- Male and female of childbearing potential must agree to use protocol specified
method(s) of contraception
Key Exclusion Criteria:
- Current or prior history: 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
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
24
sites
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