Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 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: | September 2014 |
End Date: | September 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 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks
compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants
with chronic genotype 2 hepatitis C virus (HCV) infection.
of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks
compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants
with chronic genotype 2 hepatitis C virus (HCV) infection.
Inclusion Criteria:
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL
- HCV genotype 2
- 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
- Must be of generally good health, with the exception of chronic HCV infection, as
determined by the investigator.
Exclusion Criteria:
- Current or prior history of clinically-significant illness (other than HCV that may
interfere with treatment, assessment or compliance with the protocol;
- Screening electrocardiogram (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)
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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