A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study

Study Identifier
M13-102
CT.gov Identifier
NCT01773070
EudraCT Identifier
2012-003073-26
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-450/ritonavir
  • ABT-333
  • ABT-267
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 80 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Subject has received at least one dose of ABT-450, ABT-333 or ABT-267 in a prior AbbVie HCV Phase 2 or 3 study which is being submitted as a US IND. * The interval between the last dose of the AbbVie DAA therapy from the previous clinical study and enrollment in Study M13-102 must be no longer than 2 years. * The subject must voluntarily sign and date the informed consent form. * Subject completed the post-treatment period of an eligible prior study.
    Exclusion Criteria:
    * The investigator considers the subject unsuitable for the study for any reasons. * Receipt of any investigational product from Day 1 and while enrolled in this study.

    Protocol Summary

    A follow-up study to assess resistance and durability of response to 3 experimental drugs ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3 clinical studies with these agents for the treatment of chronic hepatitis C virus (HCV). Studies include: M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998 (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389 (NCT01674725)' M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and M14-103 (NCT01911845).

    Study Locations

    No locations found.