Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults
Lead Sponsor:
AbbVie
Conditions:
Chronic Hepatitis C Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 \[ABT-450/r/ABT-267; ABT-267 also known as ombitasvir\] ...
Detailed Description
A randomized, open-label, parallel-arm, multicenter study to evaluate the safety and antiviral activity of the 3-DAA regimen (ABT-450/ritonavir/ABT-267 \[ABT-450/r/ABT-267\] and ABT-333) plus ribaviri...
Eligibility Criteria
Inclusion
- Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
- Chronic hepatitis C infection (positive for anti-HCV antibody or HCV RNA at least 6 months before screening and at the time of screening; or positive for anti-HCV antibody or HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection)
- Screening laboratory result indicating HCV genotype 1 infection (HCV GT1)
- Participant must have documentation of adherence to a prior pegIFN/RBV combination therapy and meet one of the protocol definitions for treatment failure: null responder, partial responder, relapser
- No evidence of liver cirrhosis
Exclusion
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
- Positive screen for drugs or alcohol
- Significant sensitivity to any drug
- Use of contraindicated medications within 2 weeks of dosing
- Abnormal laboratory tests
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT01854528
Start Date
June 1 2013
End Date
July 1 2015
Last Update
June 6 2018
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