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

Study Identifier
M13-862
CT.gov Identifier
NCT01854528
EudraCT Identifier
2012-003738-18
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Hepatitis
    • Study Drug
  • ABT-450/r/ABT-267, ABT-333
  • Ribavirin
  • Pegylated Interferon a-2a (PegINF)
  • Telaprevir
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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 Criteria:
    * 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

    Protocol 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 \[ABT-450/r/ABT-267; ABT-267 also known as ombitasvir\] and ABT-333 \[also known as dasabuvir\]) plus ribavirin (RBV) compared with telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).

    Study Locations

    No locations found.