Status:
COMPLETED
Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with c...
Eligibility Criteria
Inclusion
- Key
- Willing and able to provide written informed consent
- HCV genotype determined by the Central Laboratory
- HCV RNA \> LLOQ at screening
- Participated and completed a Gilead sponsored HCV treatment study of direct acting antiviral (DAA) containing regimens.
- Male and female of childbearing potential must agree to use protocol specified method(s) of contraception
- Key
Exclusion
- Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
- Screening ECG with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at screening
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2016
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT02300103
Start Date
December 1 2014
End Date
September 15 2016
Last Update
November 16 2018
Active Locations (30)
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1
San Diego, California, United States
2
San Marcos, California, United States
3
Aurora, Colorado, United States
4
Gainesville, Florida, United States