The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects

Study Identifier
P15-349
CT.gov Identifier
NCT02581020
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Hepatitis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants treated in Study M12-536 or M13-004 with the 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow-up, regardless of SVR achievement. * Participants who agree to sign the informed consent
    Exclusion Criteria:
    * Participants treated with a direct-acting antiviral agent (DAA) immediately after Study M12-536 or M13-004.

    Protocol Summary

    This study seeks to assess the durability of response and persistence of resistance to ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3 clinical study with these agents for the treatment of chronic hepatitis C.

    Study Locations

    Location
    Status
    Location
    Nagoya City University Hospital /ID# 157439
    Nagoya, Aichi-ken, Japan, 467-8602
    Status
    Not applicable
    Location
    Matsuyama Red Cross Hospital /ID# 152125
    Matsuyama, Ehime, Japan, 790-8524
    Status
    Not applicable
    Location
    National Hospital Organization Kyushu Medical Center /ID# 161759
    Fukuoka, Fukuoka, Japan, 810-8563
    Status
    Not applicable
    Location
    Fukuoka University Hospital /ID# 155965
    Fukuoka, Fukuoka, Japan, 814-0180
    Status
    Not applicable
    Location
    Kurume University Hospital /ID# 152123
    Kurume-shi, Fukuoka, Japan, 830-0011
    Status
    Not applicable
    Location
    Ogaki Municipal Hospital /ID# 158105
    Ogaki-shi, Gifu, Japan, 503-8502
    Status
    Not applicable
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