A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530

Study Identifier
M13-576
CT.gov Identifier
NCT02441283
EudraCT Identifier
2015-000452-24
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Plain Language Summary
Available Language(s): English, Dutch, German, Spanish
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Study Details

Medical Condition
  • Hepatitis
    • Study Drug
  • ABT-493
  • ABT-530
    • Phase
    Phase 2/Phase 3
    Sex
    Female & Male
    Age
    18 - 80 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Participant is male or female 18 years of age or older 2. Participant has received at least one dose of an ABT-493- and/or ABT- 530 containing regimen in a prior AbbVie hepatitis C virus (HCV) Phase 2 or 3 study 3. The interval between the last dose of the AbbVie direct-acting antiviral agent (DAA) therapy from the previous clinical study and enrollment in Study M13-576 must be no longer than 2 years for subjects who have not been retreated. Participants who have been treated with a commercially available anti-HCV treatment may be enrolled greater than 2 years after the last dose of the AbbVie DAA therapy from the previous clinical study. 4. Participant must voluntarily sign and date the informed consent form approved by an Independent Review Board or Ethics Committee prior to the initiation of any study-specific procedures. 5. Participant completed the post-treatment period of an eligible prior study.
    Exclusion Criteria:
    1. The investigator considers the participant unsuitable for the study for any reasons (e.g., failure to comply with study procedures in the prior AbbVie clinical study). 2. Receipt of any investigational HCV antiviral treatment after receiving ABT-493 and/or ABT-530 in the prior study. 3. Participants who experienced non-virologic treatment failure due to premature discontinuation of study drug in prior study of ABT-493/ABT-530. 4. Participation in AbbVie's Study M15-942 protocol for re-treatment for virologic failure in the prior Phase 2 or 3 study.

    Protocol Summary

    This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.

    Study Locations

    Location
    Status
    Location
    Digestive Health Specialists of the Southeast /ID# 136725
    Dothan, Alabama, United States, 36305
    Status
    Not applicable
    Location
    Felizarta /ID# 141033
    Bakersfield, California, United States, 93301
    Status
    Not applicable
    Location
    Southern California Res. Ctr. /ID# 141799
    Coronado, California, United States, 92118-1408
    Status
    Not applicable
    Location
    Research & Education, Inc. /ID# 169591
    San Diego, California, United States, 92105
    Status
    Not applicable
    Location
    eStudySite San Diego /ID# 141040
    San Diego, California, United States, 92120
    Status
    Not applicable
    Location
    eStudySite San Diego /ID# 141047
    San Diego, California, United States, 92120
    Status
    Not applicable
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