A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection

Study Identifier
M14-868
CT.gov Identifier
NCT02243293
EudraCT Identifier
2014-002927-90
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
  • ribavirin (RBV)
  • ABT-493/ABT-530
    • Phase
    Phase 2/Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection. * Chronic HCV infection. * Participant had to be either HCV treatment-naïve or treatment-experienced. * Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).
    Exclusion Criteria:
    * History of severe, life-threatening or other significant sensitivity to any drug. * Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was 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 co-infection with more than one HCV genotype.

    Protocol Summary

    The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5 (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.

    Study Locations

    No locations found.