Status:
COMPLETED
Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults 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
- Chronic HCV infection
- Body mass index (BMI) ≥ 18 kg/m\^2
- HCV RNA ≥ 10000 IU/mL at screening
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
- Must not have cirrhosis
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
- Prior treatment of HCV with interferon or ribavirin
- 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 :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT01858766
Start Date
April 1 2013
End Date
August 1 2014
Last Update
November 14 2018
Active Locations (51)
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1
UCSD
La Jolla, California, United States, 92037
2
University of California San Diego Medical Center
La Jolla, California, United States, 92093
3
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
4
Los Angeles Medical Center
Los Angeles, California, United States, 90027