Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/18/2018 |
| Start Date: | July 2014 |
| End Date: | December 2015 |
A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection
The primary objectives of this study are to compare the efficacy of treatment with
sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of
sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability
of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV)
infection.
sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of
sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability
of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV)
infection.
Inclusion Criteria:
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL
- HCV genotype 3
- Chronic HCV infection (≥ 6 months)
- Females of childbearing potential must have a negative serum pregnancy test
- 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) that may
interfere with subject treatment, assessment or compliance with the protocol
- Screening ECG with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at Screening
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease,
alfa-1 antitrypsin deficiency, cholangitis)
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
We found this trial at
26
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