Status:
COMPLETED
Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.
Eligibility Criteria
Inclusion
- Key
- Willing and able to provide written informed consent
- Chronic HCV infection
- Cirrhosis determination (liver biopsy may be required)
- Screening laboratory values within specified limits
- Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- Specific genotype, prior medical history, or concurrent disease as required by the specific study group
- Key
Exclusion
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- Pregnant or nursing female, or male with pregnant female partner
- Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
- Use of any prohibited concomitant medications
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
August 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2016
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT02202980
Start Date
August 4 2014
End Date
May 9 2016
Last Update
November 16 2018
Active Locations (2)
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1
Auckland, New Zealand
2
Christchurch, New Zealand