The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)

Study Identifier
M13-583
CT.gov Identifier
NCT02636595
EudraCT Identifier
2015-002349-80
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-493/ABT-530
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection. 2. Chronic HCV infection. 3. HCV treatment-naïve or treatment experienced (interferon \[IFN\] or pegylated interferon \[pegIFN\] with or without ribavirin \[RBV\]; sofosbuvir \[SOF\] plus RBV with or without pegIFN). 4. Non-cirrhotic participants.
    Exclusion Criteria:
    1. History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs. 2. Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. 3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. 4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). 5. Co-infection with more than one HCV genotype.

    Protocol Summary

    The purpose of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12 weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.

    Study Locations

    No locations found.