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

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT02581020
Collaborator
(none)
344
Enrollment
53
Locations
58.8
Actual Duration (Months)
6.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    344 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    A Follow-up Study to Assess the Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
    Actual Study Start Date :
    Jan 14, 2016
    Actual Primary Completion Date :
    Dec 8, 2020
    Actual Study Completion Date :
    Dec 8, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Participants who were treated with 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow up from the prior Phase 2 or 3 studies conducted in Japan.

    Outcome Measures

    Primary Outcome Measures

    1. Hepatitis C virus ribonucleic acid (HCV RNA) levels [60 months after completion of the 2D treatment in M12-536 or M13-004 study]

      HCV RNA levels in plasma

    Secondary Outcome Measures

    1. Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Paritaprevir in Non-structural Viral Protein 3 (NS3) [For approximately 5 years]

    2. Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Ombitasvir in Non-structural Viral Protein 5A (NS5A) [For approximately 5 years]

    3. Percentage of participants with hepatocellular carcinoma [Up to 60 month after completion of the 2D treatment in M12-536 or M13-004]

    4. Number of participants with serious adverse events (SAEs) [Up to 60 month after completion of the 2D treatment in M132-536 or M13-004 study]

      All serious adverse events will be monitored during the observation period.

    5. Hepatitis C virus ribonucleic acid (HCV RNA) levels [18, 24, 30, 36, 42, 48, 52 months after completion of the 2D treatment in M12-536 or M13-004 study]

      HCV RNA levels in plasma

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nagoya City University Hospital /ID# 157439 Nagoya-shi Aichi Japan 467-8602
    2 Matsuyama Red Cross Hospital /ID# 152125 Matsuyama-shi Ehime Japan 790-8524
    3 National Hospital Organization Kyushu Medical Center /ID# 161759 Fukuoka-shi Fukuoka Japan 810-8563
    4 Fukuoka University Hospital /ID# 155965 Fukuoka-shi Fukuoka Japan 814-0180
    5 Kurume University Hospital /ID# 152123 Kurume-shi Fukuoka Japan 830-0011
    6 Ogaki Municipal Hospital /ID# 158105 Ogaki-shi Gifu Japan 503-8502
    7 Gunma University Hospital /ID# 158118 Maebashi-shi Gunma Japan 371-8511
    8 National Hospital Organization Takasaki General Medical Center /ID# 152128 Takasaki-shi Gunma Japan 370-0829
    9 Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 152178 Hiroshima-shi Hiroshima Japan 730-8619
    10 Hiroshima University Hospital /ID# 152232 Hiroshima-shi Hiroshima Japan 734-8551
    11 Obihiro kosei Hospital /ID# 157437 Obihiro-shi Hokkaido Japan 080-0024
    12 Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 153019 Sapporo-shi Hokkaido Japan 060-0033
    13 Hitachi General Hospital /ID# 160800 Hitachi-shi Ibaraki Japan 317-0077
    14 Duplicate_Kanazawa University Hospital /ID# 152226 Kanazawa-shi Ishikawa Japan 920-8641
    15 Kagawa University Hospital /ID# 153548 Kita-gun Kagawa Japan 761-0793
    16 Duplicate_Yokohama City University Medical Center /ID# 159474 Yokohama-shi Kanagawa Japan 232-0024
    17 Yokohama City University Hospital /ID# 165252 Yokohama-shi Kanagawa Japan 236-0004
    18 Kumamoto Shinto General Hospital /ID# 150061 Kumamoto-shi Kumamoto Japan 8628655
    19 Okayama University Hospital /ID# 150060 Okayama-shi Okayama Japan 700-8558
    20 Osaka City General Hospital /ID# 152126 Osaka-shi Osaka Japan 534-0021
    21 Japanese Red Cross Osaka Hospital /ID# 155964 Osaka-shi Osaka Japan 543-8555
    22 Saga University Hospital /ID# 161757 Saga-shi Saga Japan 849-8501
    23 Saitama Medical University Hospital /ID# 153544 Iruma-gun Saitama Japan 350-0451
    24 Hamamatsu University Hospital /ID# 152176 Hamamatsu-shi Shizuoka Japan 431-3192
    25 Dokkyo Medical University Hospital /ID# 152225 Shimotsuga-gun Tochigi Japan 321-0293
    26 Jichi Medical University Hospital /ID# 153018 Shimotsuke-shi Tochigi Japan 329-0498
    27 Juntendo University Hospital /ID# 153545 Bunkyo-ku Tokyo Japan 113-8431
    28 The University of Tokyo Hospital /ID# 158121 Bunkyo-ku Tokyo Japan 113-8655
    29 Toranomon Hospital /ID# 152124 Minato-ku Tokyo Japan 105-8470
    30 Kitasato University Kitasato Institute Hospital /ID# 152145 Minato-ku Tokyo Japan 108-8642
    31 Toyama Prefectural Central Hospital /ID# 164156 Toyama-shi Toyama Japan 930-8550
    32 Yamaguchi University Hospital /ID# 166899 Ube-shi Yamaguchi Japan 755-8505
    33 University of Yamanashi Hospital /ID# 153547 Chuo-shi Yamanashi Japan 409-3821
    34 Asakura Medical Association Ho /ID# 155963 Asakura Japan 838-0069
    35 Fukuiken Saiseikai Hospital /ID# 162898 Fukui Japan 918-8235
    36 Gifu Municipal Hospital /ID# 152227 Gifu Japan 500-8323
    37 Gifu Prefectural Genl Med Ctr /ID# 154796 Gifu Japan 500-8727
    38 Ikeda Municipal Hospital /ID# 150062 Ikeda Japan 563-8510
    39 Tokyo Med Uni Ibaraki Med Ctr /ID# 152127 Inashiki Japan 300-0332
    40 Nippon Med Chiba Hokusoh Hosp /ID# 164155 Inzai Japan 270-1613
    41 Kagoshima Uni Med and Dental /ID# 157438 Kagoshima Japan 890-8520
    42 Toranomon Hospital Kajigaya /ID# 152129 Kawasaki Japan 213-8587
    43 Kawasaki Municipal Tama Hospit /ID# 153546 Kawasaki Japan 214-0021
    44 Ehime Prefectural Central Hosp /ID# 158106 Matsuyama Japan 790-0024
    45 Kawasaki Hosp, Kawasaki Med /ID# 152180 Okayama Japan 700-0821
    46 Osaka Hospital /ID# 152177 Osaka Japan 572-0854
    47 Japanese Red Cross Saitama Hos /ID# 166898 Saitama Japan 338-8553
    48 Saiseikai Suita Hospital /ID# 153549 Suita Japan 564-0013
    49 Kagawa Prefectural Central Hos /ID# 152179 Takamatsu Japan 760-0065
    50 Nat Hosp Org Minami Wakayama /ID# 153550 Tanabe Japan 646-8558
    51 Toshiba General Hospital /ID# 152122 Tokyo Japan 140-8522
    52 JP Red Cross Musashino Hosp /ID# 152175 Tokyo Japan 180-8610
    53 Oita University Hospital /ID# 165274 Yufu-shi Japan 879-5503

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: AbbVie Inc., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02581020
    Other Study ID Numbers:
    • P15-349
    First Posted:
    Oct 20, 2015
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Hepatitis C
    Follow-up
    Observation
    Japanese
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis

    Study Results

    No Results Posted as of Dec 8, 2021