A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Study Identifier
M12-746
CT.gov Identifier
NCT01306617
EudraCT Identifier
Not available
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
  • ABT-333
  • ribavirin
  • ritonavir
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Chronic hepatitis C virus (HCV) * Treatment naive, null or partial responders to previous treatment with peginterferon and ribavirin * Males and females 18-65 years old * Body mass index 18 to \< 35 kg/m\^2 * Females must be postmenopausal for at least 2 years or surgically sterile
    Exclusion Criteria:
    * Cirrhosis or extensive bridging fibrosis * History of cardiac disease * Positive screen for certain drugs or alcohol * Abnormal laboratory results * Significant sensitivity to any drug * Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody * Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing

    Protocol Summary

    The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 48263
    Los Angeles, California, United States, 90048
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 48264
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 51282
    Gainesville, Florida, United States, 32610
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 50425
    Springfield, Massachusetts, United States, 01105
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 50423
    Kansas City, Missouri, United States, 64131
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 48268
    New York, New York, United States, 10016
    Status
    Not applicable
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