Status:
COMPLETED
Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naiv...
Eligibility Criteria
Inclusion
- Body mass index (BMI) ≥ 18 kg/m\^2
- HCV RNA ≥ 10000 IU/mL at screening
- Prior treatment failure to a regimen including interferon with or without RBV
- HCV genotype 1 or 3
- Chronic HCV infection
- Cirrhosis determination
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion
- Current or prior history of clinically significant illness other than HCV
- Screening ECG with clinically significant abnormalities
- Prior exposure to HCV specific direct acting antiviral agent
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of non-HCV etiology
- Hepatitis B
- Active drug abuse
- Use of any prohibited concomitant medications
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT01909804
Start Date
June 1 2013
End Date
August 1 2014
Last Update
November 15 2018
Active Locations (49)
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1
Long Beach, California, United States
2
Los Angeles, California, United States
3
Pasadena, California, United States
4
San Diego, California, United States