A Study to Evaluate Chronic Hepatitis C Infection

Study Identifier
M11-646
CT.gov Identifier
NCT01716585
EudraCT Identifier
2012-002019-25
EUCTIS ID
Not available
For general inquiries, please contact

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
  • Placebo for ABT-450/r/ABT-267
  • Placebo for ABT-333
  • Placebo for ribavirin
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 70 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control * Chronic hepatitis C, genotype 1-infection and HCV RNA level greater than 10,000 IU/mL at screening * Subject has never received antiviral treatment for hepatitis C infection * No evidence of liver cirrhosis
    Exclusion Criteria:
    * Positive screen for drugs or alcohol * Significant sensitivity to any drug * Use of contraindicated medications within 2 weeks of dosing * Certain predefined abnormal laboratory tests * Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody

    Protocol Summary

    The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.

    Study Locations

    No locations found.