A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection

Study Identifier
M15-464
CT.gov Identifier
NCT02640482
EudraCT Identifier
2015-002348-14
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
Download document(s)

Study Details

Medical Condition
  • Hepatitis
    • Study Drug
  • ABT-493/ABT-530
  • Placebo for ABT-493/ABT-530
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Screening laboratory result indicating hepatitis C virus (HCV) Genotype-2 (GT2) infection. * Chronic HCV infection. * Subject must be HCV treatment-naïve (subject had never received a single dose of any approved or investigational regimen) or had failed prior interferon (IFN) or pegylated-interferon (pegIFN) ± ribavirin (RBV) or sofosbuvir (SOF) + RBV ± pegIFN therapy. * Subject must be non-cirrhotic.
    Exclusion Criteria:
    * History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs. * 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. * 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. * Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). * HCV genotype performed during screening indicating coinfection with more than 1 HCV genotype.

    Protocol Summary

    The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in adults with genotype 2 chronic hepatitis C virus (HCV) infection.

    Study Locations

    No locations found.