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Drug Use-Results Survey in Participants Infected With Hepatitis C Virus Genotype 2

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT02945228
Collaborator
(none)
449
Enrollment
170
Locations
33
Actual Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic hepatitis C virus (HCV) genotype 2 in daily practice in Japan.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    449 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Drug Use-Results Survey in Patients Infected With Hepatitis C Virus Genotype 2
    Actual Study Start Date :
    Oct 26, 2016
    Actual Primary Completion Date :
    Jul 26, 2019
    Actual Study Completion Date :
    Jul 26, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Chronic infection of hepatitis C virus (HCV) genotype 2

    Participants with confirmed chronic HCV genotype 2, receiving paritaprevir/ritonavir/ombitasvir and ribavirin according to standard of care and in line with the current local label

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Sustained Virologic Response (SVR12) [12 weeks after last dose of study drug.]

      Hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug.

    Secondary Outcome Measures

    1. Percentage of Participants with Virologic Failure During Treatment (breakthrough) [Up to 12 Weeks]

      HCV RNA levels reach less than the LLOQ, then increase to greater than or equal to the LLOQ at any point during treatment.

    2. Percentage of Participants with Virologic Failure After Treatment (relapse) [Post-treatment 24 weeks]

      Undetectable viremia (HCV RNA less than LLOQ) at the end of the 16 weeks treatment but subsequent viremia (HCV RNA greater than or equal to LLOQ) during the follow-up period of 24 weeks after treatment.

    3. Percentage of Participants with Sustained Virologic Response (SVR24) [24 weeks after the last dose of study drug]

      HCV RNA less than the LLOQ 24 weeks after the last dose of study drug.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • HCV genotype 2 participants treated with paritaprevir/ritonavir/ombitasvir plus ribavirin in daily practice.
    Exclusion Criteria:
    • Participants who have been previously treated with paritaprevir/ritonavir/ombitasvir and ribavirin.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aichi Medical University Hosp /ID# 161892 Nagakute Aichi Japan 4801195
    2 Matsuyama Red Cross Hosp /ID# 162953 Matsuyama Ehime Japan 7900826
    3 NHO Kyushu Medical Center /ID# 162956 Fukuoka-shi Fukuoka Japan 810-8563
    4 Kurume University Hospital /ID# 164158 Kurume-shi Fukuoka Japan 830-0011
    5 Kusunoki Hospital /ID# 158119 Fujioka Gunma Japan 3750024
    6 National Hospital Organization Takasaki General Medical Center /ID# 160877 Takasaki-shi Gunma Japan 370-0829
    7 NHO Fukuyama Medical Center /ID# 162909 Fukuyama-shi Hiroshima Japan 720-8520
    8 Fukuyama City Hospital /ID# 161889 Fukuyama-shi Hiroshima Japan 721-8511
    9 The Hospital of Hyogo College of Medicine /ID# 162913 Nishinomiya-shi Hyogo Japan 663-8501
    10 Nanpuh Hospital /ID# 168348 Kagoshima-shi Kagoshima Japan 8928512
    11 St. Marianna University School of Medicine Hospital /ID# 160876 Kawasaki Kanagawa Japan 216-0015
    12 Yokohama City Univ Medical Ctr /ID# 162905 Yokohama Kanagawa Japan 232-0024
    13 Kumamoto University Hospital /ID# 167048 Kumamoto-shi Kumamoto Japan 860-8556
    14 Kumamoto Shinto General Hospital /ID# 165275 Kumamoto-shi Kumamoto Japan 8628655
    15 Okayama University Hospital /ID# 165268 Okayama-shi Okayama Japan 700-8558
    16 Osaka Red Cross Hospital /ID# 161888 Osaka-shi Osaka Japan 543-8555
    17 Osaka City University Hospital /ID# 165290 Osaka-shi Osaka Japan 545-0051
    18 Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 167688 Osaka-shi Osaka Japan 550-0006
    19 Osaka Medical College Hospital /ID# 162908 Takatsuki -shi Osaka Japan 569-8686
    20 Saitama Medical Center, Saitama Medical University /ID# 162911 Kawagoe-shi Saitama Japan 350-8550
    21 Dokkyo Medical University Saitama Medical Center /ID# 162907 Koshigaya Saitama Japan 343-0813
    22 Hamamatsu University Hospital /ID# 171048 Hamamatsu Shizuoka Japan 431-3125
    23 Tokyo Jikei Daisan Hospital /ID# 164159 Komae-shi Tokyo Japan 201-8601
    24 Tokyo Women's Medical University Hospital /ID# 167685 Shinjuku-ku Tokyo Japan 162-8666
    25 University of Yamanashi Hospital /ID# 161770 Chuo-shi Yamanashi Japan 409-3898
    26 Kato Michio Hepatology Clinic /ID# 159476 Amagasaki, Hyogo Japan 661-0012
    27 Aomori Prefectural Central Hos /ID# 160822 Aomori-shi Japan 030-8553
    28 Mantani Clinic /ID# 168353 Arida Japan 649-0316
    29 Asahikawa City Hospital /ID# 167703 Asahikawa-shi Japan 070-8610
    30 Japanese Red Cross Asahikawa /ID# 165265 Asahikawa Japan 070-0061
    31 National Hospital Organization /ID# 168346 Chiba Japan 260-0042
    32 Chiba University Hospital /ID# 160875 Chiba Japan 260-8677
    33 Seirei Sakura Citizen Hospital /ID# 166896 Chiba Japan
    34 Kenseido-iin /ID# 164166 Chichibu Japan 368-0042
    35 Fuji City General Hospital /ID# 165278 Fuji Japan
    36 Fukui Prefectural Hospital /ID# 168344 Fukui Japan 910-0846
    37 Fukui Prefectural Hospital /ID# 169552 Fukui Japan 910-0846
    38 University of Fukui Hospital /ID# 166933 Fukui Japan 910-1104
    39 Chihaya Hospital /ID# 161893 Fukuoka Japan
    40 Morichika Internal Medicine /ID# 168351 Fukuyama Japan 721-0975
    41 Gifu Municipal Hospital /ID# 165287 Gifu Japan 500-8323
    42 Shiroyama Hospital /ID# 164963 Habikino-osaka Japan 583-0872
    43 Aomori Rosai Hospital /ID# 167702 Hachinohe Japan
    44 Tamakoshi Clinic /ID# 165282 Hamamatsu Japan 335-0023
    45 Higashihiroshima Medical Ctr /ID# 168343 Higashihiroshima Japan 739-0041
    46 Mito Medical Center /ID# 171046 Higashiibaraki-gun Japan 311-3117
    47 Higashiomicity Notogawa Hosp /ID# 161891 Higashiomi, Shiga Japan 521-1223
    48 Shin-ishikiri Clinic /ID# 169643 Higashiosaka Japan 579-8013
    49 Wakakusa Daiichi Hospital /ID# 166882 Higashiosaka Japan 579-8056
    50 Hiroshima Red Cross Hosp Atomi /ID# 162912 Hiroshima Japan 730-0052
    51 Hiroshima University Hospital /ID# 160815 Hiroshima Japan 734-8551
    52 Hiroshima-Nishi Medical Center /ID# 169642 Hiroshima Japan 739-0651
    53 Koyo New Town Hospital /ID# 161890 Hiroshima Japan 739-1742
    54 Taishi Hospital /ID# 165291 Hyogo Japan 671-1561
    55 Iizuka Hospital /ID# 161886 Iizuka Japan 820-0018
    56 Ikeda Municipal Hospital /ID# 160814 Ikeda Japan 563-8510
    57 Tokyo Med Uni Ibaraki Med Ctr /ID# 162955 Inashiki Japan 300-0332
    58 Nippon Med Chiba Hokusoh Hosp /ID# 162902 Inzai Japan 270-1613
    59 Saitama Medical University Hos /ID# 161768 Iruma-gun Japan 350-0451
    60 Itoigawa Sogo Hospital /ID# 166884 Itoigawa Japan 941-0006
    61 Kamiiwade Internal Med-Neuro /ID# 166881 Iwade Japan 649-6216
    62 Kaizuka City Hospital /ID# 165256 Kaizuka Japan
    63 Kamisu Saiseikai Hospital /ID# 167701 Kamisu Japan 314-0112
    64 Kiyokawa Hospital /ID# 164961 Kanagawa Japan 166-0004
    65 Hiratsuka City Hospital /ID# 161884 Kanagawa Japan
    66 Niwa Hospital /ID# 167684 Kanagawa Japan
    67 Fuji Clinic /ID# 160820 Kanonji Japan 3440067
    68 Ibaraki Prefectural Cent. Hosp /ID# 164962 Kasama Japan 309-1703
    69 The Jikei Univ. Kashiwa Hosp. /ID# 166888 Kashiwa-shi Japan 277-0004
    70 Kashiwazaki General Hospital a /ID# 168352 Kashiwazaki Japan 945-0035
    71 Kawase Clinic /ID# 164957 Kasugai Japan 486-0914
    72 Hirose Clinic /ID# 167699 Kawagoe Japan 350-0043
    73 Sekishindo Hospital /ID# 162960 Kawagoe Japan 350-1123
    74 Kawaguchi Municipal Medical Ce /ID# 165270 Kawaguchi Japan 333-0833
    75 Kanto Rosai Hospital /ID# 165258 Kawasaki-shi, Kanagawa Japan
    76 Kawasaki Municipal Tama Hospit /ID# 165267 Kawasaki Japan 214-0021
    77 Kishiwada Tokushukai Hospital /ID# 164964 Kishiwada, Osaka Japan 596-0042
    78 Kokura Kinen Hospital /ID# 164969 Kitakyusyu Japan 802-0001
    79 Kitasato University Medical Ce /ID# 158120 Kitamoto Japan 364-0026
    80 Kobe Asahi Hospital /ID# 161896 Kobe Japan 653-0801
    81 Kobe Adventist Hospital /ID# 161897 Kobe Japan
    82 Konan Kosei Hospital /ID# 165277 Konan-shi Japan 483-8704
    83 Cosmos Clinic /ID# 164161 Koriyama Japan 963-0209
    84 Ishida Medical Clinic /ID# 166887 Koriyama Japan 963-8023
    85 Hanada Internal Medicine Clin /ID# 165266 Koshigaya, Saitam Japan 343-0015
    86 Kawasaki Medical School Hosp /ID# 162906 Kurashiki Japan 701-0114
    87 National Hosp Org Kure Med Cen /ID# 167689 Kure, Hiroshima Japan 737-0023
    88 Kurihara Central Hospital /ID# 171047 Kurihara Japan 228-0014
    89 Kuroishi Hospital /ID# 164971 Kuroishi-aomori Japan 036-0541
    90 Shin Koga Clinic /ID# 164972 Kurume Japan 830-0033
    91 Koga Hospital 21 /ID# 167698 Kurume Japan 839-0801
    92 Hori Internal Medicine Clinic /ID# 167696 Kushiro Japan 085-0005
    93 NHO Kyoto Medical Center /ID# 162910 Kyoto Japan 612-0861
    94 Matsuzaki Internal Medicine Cl /ID# 164970 Kyoto Japan 615-8101
    95 Gibo Hepatorogy Clinic /ID# 161766 Matsumoto Japan 399-0036
    96 Kizawa Memorial Hospital /ID# 162957 Minokamo Japan 505-0034
    97 Sumiyoshi Clinic Hospital /ID# 164163 Mito Japan 310-0844
    98 South Miyagi Medical Center /ID# 164965 Miyagi Japan 989-1253
    99 National Hospital Organization /ID# 168345 Miyakonojo Japan 885-0014
    100 University of Miyazaki Hosp /ID# 166880 Miyazaki-shi Japan 889-1692
    101 Miyazaki Medical Center Hospit /ID# 165279 Miyazaki Japan 880-0003
    102 Matsushita Memorial Hospital /ID# 167693 Moriguchi-shi Japan 570-0096
    103 Suzuki Clinic /ID# 165264 Nagareyama Japan 270-0157
    104 Meijo Hospital /ID# 164966 Nagoya-aichi Japan 460-0001
    105 Nagoya Central Hospital /ID# 166879 Nagoya-shi Japan 453-0801
    106 Meitetsu Hospital /ID# 165288 Nagoya Japan 451-8511
    107 Aikawa Minnano-shinryojo /ID# 164168 Nagoya Japan 458-0011
    108 Nara City Hospital /ID# 162959 Nara Japan 530-0025
    109 Tani Internal Medicine Clinic /ID# 164974 Nayoro Japan 096-0018
    110 Ooka Clinic /ID# 161887 Nishinomiya Japan 663-8124
    111 Noshiro Yamamoto Med. Assoc. /ID# 162964 Noshiro Japan 016-0151
    112 Manna Clinic /ID# 169548 Odawara Japan 250-0214
    113 Oita Midical Center /ID# 164960 Oita Japan 870-0263
    114 Okayama Saiseikai Outpatient Center Hospital /ID# 159475 Okayama Japan 700-0013
    115 Omuta City Hospital /ID# 164967 Omuta Japan 836-0861
    116 Onomichi Central General Hospi /ID# 162903 Onomichi Japan
    117 Kita-harima Medical Center /ID# 164165 ONO Japan 675-1327
    118 Kenporen Osaka Central Hospita /ID# 164956 Osaka Japan 530-0001
    119 Asai Naika /ID# 167691 Osaka Japan 537-0024
    120 Osaka Inter. Cancer Institute /ID# 166889 Osaka Japan 541-8567
    121 Osaka Police Hospital /ID# 161769 Osaka Japan 543-0035
    122 Asai Naika Iin /ID# 164955 Osaka Japan 546-0043
    123 Utajima Ueda Clinic /ID# 161894 Osaka Japan 555-0012
    124 Tamai Clinic /ID# 164162 Osaka Japan 557-0002
    125 Osaka Hospital /ID# 164157 Osaka Japan 572-0854
    126 Seko Internal Medicine Clinic /ID# 164169 Otsu Japan 520-0802
    127 Kawazoe Internal Medicine Clin /ID# 165292 Saga Japan 849-1113
    128 Saitama Citizens Medical Ctr /ID# 169550 Saitama Japan 331-0054
    129 Sainokuni Higashiomiya Medical /ID# 167700 Saitama Japan 331-0804
    130 Honda Internal Clinic /ID# 161767 Saitama Japan 349-0115
    131 Saitama Cooperative Hospital /ID# 167697 Saitama Japan
    132 Minamitani Clinic /ID# 160821 Sakai Japan 590-0026
    133 Kaisei Hospital /ID# 164973 Sapporo Japan 001-0033
    134 Sendai Kousei Hospital /ID# 162961 Sendai Japan 980-0873
    135 Saka General Hospital /ID# 162962 Shiogama-miyagi Japan 985-0024
    136 Suita Municipal Hospital /ID# 164958 Suita-osaka Japan 564-0082
    137 Saiseikai Suita Hospital /ID# 165289 Suita Japan 564-0013
    138 Kagawa Prefectural Central Hos /ID# 160816 Takamatsu Japan 760-0065
    139 Sawada Hepatology & Gastro /ID# 165255 Takaraduka Japan 665-0881
    140 Tenjin Tanaka Internal Medicin /ID# 166883 Takatsuki Japan 569-1123
    141 Hamada Clinic /ID# 171045 Tatebayashi Japan 374-0053
    142 Todachuo General Hospital /ID# 165280 Toda-shi, Saitama Japan 335-0023
    143 Eastern Chiba Medical Center /ID# 165257 Togane, Chiba Japan 283-0826
    144 Delta Clinic /ID# 164167 Tokorozawa Japan 359-0037
    145 The Jikei University Hospital /ID# 169547 Tokyo Japan 105-8461
    146 Abbott Japan /ID# 144983 Tokyo Japan 108-6303
    147 Juntendo University Hospital /ID# 161771 Tokyo Japan 113-8431
    148 Nippon Medical School Hospital /ID# 164164 Tokyo Japan 113-8602
    149 Tokyo Metropolitan Bokutoh Hos /ID# 167686 Tokyo Japan 130-8575
    150 Ohashi Medical Office /ID# 164968 Tokyo Japan 173-0021
    151 Juntendo Univ Nerima Hosp /ID# 164160 Tokyo Japan 177-0033
    152 JP Red Cross Musashino Hosp /ID# 162904 Tokyo Japan 180-8610
    153 Ehime University Hospital /ID# 161885 Toon Japan 791-0204
    154 Toyama University Hospital /ID# 169551 Toyoma Japan 930-0194
    155 Toyonaka Municipal Hospital /ID# 167692 Toyonaka Japan 560-8565
    156 Mie Syokaki Clinic /ID# 161895 Tsu, Mie Japan 514-0062
    157 Saiseikai Utsunomiya Hospital /ID# 162958 Utsunomiya Japan 321-0974
    158 Seike Clinic /ID# 166890 Uwajima Japan 798-0032
    159 Wakayama Rosai Hospital /ID# 165254 Wakayama-shi Japan 640-8505
    160 Saiseikai Wakayama Hospital /ID# 162954 Wakayama Japan 640-8158
    161 Tokyo Women's Medical Universi /ID# 167694 Yachiyo Japan 276-0046
    162 Tohoku Central Hospital /ID# 166897 Yamagata Japan 990-0064
    163 Okuda Gastrointestinal Medicin /ID# 168349 Yamaguchi Japan 753-0047
    164 Kainan Hospital /ID# 164959 Yatomi-shi Japan 498-0017
    165 Kumamoto Rosai Hospital /ID# 167695 Yatsushiro-shi Japan
    166 Mie Prefectural General Medica /ID# 162963 Yokkaichi Japan 510-0885
    167 Showa Univ Fujigaoka Hosp /ID# 162952 Yokohama-shi Japan 227-0043
    168 Oita University Hospital /ID# 169549 Yufu-shi Japan 879-5503
    169 Yamaguchi Surgery Clinic /ID# 167704 Yugawara Japan 259-0313
    170 Josai Hospital /ID# 168347 Yuki Japan 307-0001

    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:
    NCT02945228
    Other Study ID Numbers:
    • P15-764
    First Posted:
    Oct 26, 2016
    Last Update Posted:
    Jun 12, 2020
    Last Verified:
    Jun 1, 2020
    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
    Genotype 2
    Paritaprevir
    Hepatitis C Virus (HCV)
    Ritonavir
    Ombitasvir
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis

    Study Results

    No Results Posted as of Jun 12, 2020