Status:
COMPLETED
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
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT02220998
Start Date
September 1 2014
End Date
September 1 2015
Last Update
November 15 2018
Active Locations (51)
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1
Long Beach, California, United States, 90822
2
Los Angeles, California, United States, 90027
3
Los Angeles, California, United States, 90036
4
Los Angeles, California, United States, 90048