Status:
COMPLETED
Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (H...
Eligibility Criteria
Inclusion
- Chronic genotype 1, 2, 3, or 6 HCV infection
- Cirrhosis determination; a liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion
- Pregnant or nursing female or male with pregnant female partner
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
359 Patients enrolled
Trial Details
Trial ID
NCT01826981
Start Date
April 1 2013
End Date
May 1 2015
Last Update
November 16 2018
Active Locations (2)
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1
Auckland Clinical Studies Ltd.
Auckland, New Zealand
2
Christchurch Clinical Studies Trust
Christchurch, New Zealand