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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Sustained Virologic Response (SVR12) | Hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug. | 12 weeks after last dose of study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Virologic Failure During Treatment (breakthrough) | HCV RNA levels reach less than the LLOQ, then increase to greater than or equal to the LLOQ at any point during treatment. | Up to 12 Weeks |
| Percentage of Participants with Virologic Failure After Treatment (relapse) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with Chronic hepatitis C virus (HCV) genotype 2
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Medical University Hosp /ID# 161892 | Nagakute | Aichi-ken | 4801195 | Japan | ||
| Matsuyama Red Cross Hosp /ID# 162953 |
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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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. |
| Post-treatment 24 weeks |
| Percentage of Participants with Sustained Virologic Response (SVR24) | HCV RNA less than the LLOQ 24 weeks after the last dose of study drug. | 24 weeks after the last dose of study drug |
| Matsuyama |
| Ehime |
| 7900826 |
| Japan |
| NHO Kyushu Medical Center /ID# 162956 | Fukuoka | Fukuoka | 810-8563 | Japan |
| Kurume University Hospital /ID# 164158 | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Kusunoki Hospital /ID# 158119 | Fujioka | Gunma | 3750024 | Japan |
| National Hospital Organization Takasaki General Medical Center /ID# 160877 | Takasaki-shi | Gunma | 370-0829 | Japan |
| NHO Fukuyama Medical Center /ID# 162909 | Fukuyama-shi | Hiroshima | 720-8520 | Japan |
| Fukuyama City Hospital /ID# 161889 | Fukuyama-shi | Hiroshima | 721-8511 | Japan |
| The Hospital of Hyogo College of Medicine /ID# 162913 | Nishinomiya-shi | Hyōgo | 663-8501 | Japan |
| Nanpuh Hospital /ID# 168348 | Kagoshima | Kagoshima-ken | 8928512 | Japan |
| St. Marianna University School of Medicine Hospital /ID# 160876 | Kawasaki | Kanagawa | 216-0015 | Japan |
| Yokohama City Univ Medical Ctr /ID# 162905 | Yokohama | Kanagawa | 232-0024 | Japan |
| Kumamoto University Hospital /ID# 167048 | Kumamoto | Kumamoto | 860-8556 | Japan |
| Kumamoto Shinto General Hospital /ID# 165275 | Kumamoto | Kumamoto | 8628655 | Japan |
| Okayama University Hospital /ID# 165268 | Okayama | Okayama-ken | 700-8558 | Japan |
| Osaka Red Cross Hospital /ID# 161888 | Osaka | Osaka | 543-8555 | Japan |
| Osaka City University Hospital /ID# 165290 | Osaka | Osaka | 545-0051 | Japan |
| Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 167688 | Osaka | Osaka | 550-0006 | Japan |
| Osaka Medical College Hospital /ID# 162908 | Takatsuki -shi | Osaka | 569-8686 | Japan |
| Saitama Medical Center, Saitama Medical University /ID# 162911 | Kawagoe-shi | Saitama | 350-8550 | Japan |
| Dokkyo Medical University Saitama Medical Center /ID# 162907 | Koshigaya | Saitama | 343-0813 | Japan |
| Hamamatsu University Hospital /ID# 171048 | Hamamatsu | Shizuoka | 431-3125 | Japan |
| Tokyo Jikei Daisan Hospital /ID# 164159 | Komae-shi | Tokyo | 201-8601 | Japan |
| Tokyo Women's Medical University Hospital /ID# 167685 | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| University of Yamanashi Hospital /ID# 161770 | Chuo-shi | Yamanashi | 409-3898 | Japan |
| Kato Michio Hepatology Clinic /ID# 159476 | Amagasaki, Hyogo | 661-0012 | Japan |
| Aomori Prefectural Central Hos /ID# 160822 | Aomori | 030-8553 | Japan |
| Mantani Clinic /ID# 168353 | Arida | 649-0316 | Japan |
| Japanese Red Cross Asahikawa /ID# 165265 | Asahikawa | 070-0061 | Japan |
| Asahikawa City Hospital /ID# 167703 | Asahikawa-shi | 070-8610 | Japan |
| National Hospital Organization /ID# 168346 | Chiba | 260-0042 | Japan |
| Chiba University Hospital /ID# 160875 | Chiba | 260-8677 | Japan |
| Seirei Sakura Citizen Hospital /ID# 166896 | Chiba | Japan |
| Kenseido-iin /ID# 164166 | Chichibu | 368-0042 | Japan |
| Fuji City General Hospital /ID# 165278 | Fuji | Japan |
| Fukui Prefectural Hospital /ID# 168344 | Fukui | 910-0846 | Japan |
| Fukui Prefectural Hospital /ID# 169552 | Fukui | 910-0846 | Japan |
| University of Fukui Hospital /ID# 166933 | Fukui | 910-1104 | Japan |
| Chihaya Hospital /ID# 161893 | Fukuoka | Japan |
| Morichika Internal Medicine /ID# 168351 | Fukuyama | 721-0975 | Japan |
| Gifu Municipal Hospital /ID# 165287 | Gifu | 500-8323 | Japan |
| Shiroyama Hospital /ID# 164963 | Habikino-osaka | 583-0872 | Japan |
| Aomori Rosai Hospital /ID# 167702 | Hachinohe | Japan |
| Tamakoshi Clinic /ID# 165282 | Hamamatsu | 335-0023 | Japan |
| Higashihiroshima Medical Ctr /ID# 168343 | Higashihiroshima | 739-0041 | Japan |
| Mito Medical Center /ID# 171046 | Higashiibaraki-gun | 311-3117 | Japan |
| Higashiomicity Notogawa Hosp /ID# 161891 | Higashiomi, Shiga | 521-1223 | Japan |
| Shin-ishikiri Clinic /ID# 169643 | Higashiosaka | 579-8013 | Japan |
| Wakakusa Daiichi Hospital /ID# 166882 | Higashiosaka | 579-8056 | Japan |
| Hiroshima Red Cross Hosp Atomi /ID# 162912 | Hiroshima | 730-0052 | Japan |
| Hiroshima University Hospital /ID# 160815 | Hiroshima | 734-8551 | Japan |
| Hiroshima-Nishi Medical Center /ID# 169642 | Hiroshima | 739-0651 | Japan |
| Koyo New Town Hospital /ID# 161890 | Hiroshima | 739-1742 | Japan |
| Taishi Hospital /ID# 165291 | Hyōgo | 671-1561 | Japan |
| Iizuka Hospital /ID# 161886 | Iizuka | 820-0018 | Japan |
| Ikeda Municipal Hospital /ID# 160814 | Ikeda | 563-8510 | Japan |
| Tokyo Med Uni Ibaraki Med Ctr /ID# 162955 | Inashiki | 300-0332 | Japan |
| Nippon Med Chiba Hokusoh Hosp /ID# 162902 | Inzai | 270-1613 | Japan |
| Saitama Medical University Hos /ID# 161768 | Iruma-gun | 350-0451 | Japan |
| Itoigawa Sogo Hospital /ID# 166884 | Itoigawa | 941-0006 | Japan |
| Kamiiwade Internal Med-Neuro /ID# 166881 | Iwade | 649-6216 | Japan |
| Kaizuka City Hospital /ID# 165256 | Kaizuka | Japan |
| Kamisu Saiseikai Hospital /ID# 167701 | Kamisu | 314-0112 | Japan |
| Kiyokawa Hospital /ID# 164961 | Kanagawa | 166-0004 | Japan |
| Hiratsuka City Hospital /ID# 161884 | Kanagawa | Japan |
| Niwa Hospital /ID# 167684 | Kanagawa | Japan |
| Fuji Clinic /ID# 160820 | Kan’onjichō | 3440067 | Japan |
| Ibaraki Prefectural Cent. Hosp /ID# 164962 | Kasama | 309-1703 | Japan |
| The Jikei Univ. Kashiwa Hosp. /ID# 166888 | Kashiwa-shi | 277-0004 | Japan |
| Kashiwazaki General Hospital a /ID# 168352 | Kashiwazaki | 945-0035 | Japan |
| Kawase Clinic /ID# 164957 | Kasugai | 486-0914 | Japan |
| Hirose Clinic /ID# 167699 | Kawagoe | 350-0043 | Japan |
| Sekishindo Hospital /ID# 162960 | Kawagoe | 350-1123 | Japan |
| Kawaguchi Municipal Medical Ce /ID# 165270 | Kawaguchi | 333-0833 | Japan |
| Kawasaki Municipal Tama Hospit /ID# 165267 | Kawasaki | 214-0021 | Japan |
| Kanto Rosai Hospital /ID# 165258 | Kawasaki-shi, Kanagawa | Japan |
| Kishiwada Tokushukai Hospital /ID# 164964 | Kishiwada, Osaka | 596-0042 | Japan |
| Kokura Kinen Hospital /ID# 164969 | Kitakyushu | 802-0001 | Japan |
| Kitasato University Medical Ce /ID# 158120 | Kitamoto | 364-0026 | Japan |
| Kobe Asahi Hospital /ID# 161896 | Kobe | 653-0801 | Japan |
| Kobe Adventist Hospital /ID# 161897 | Kobe | Japan |
| Konan Kosei Hospital /ID# 165277 | Konan-shi | 483-8704 | Japan |
| Hanada Internal Medicine Clin /ID# 165266 | Koshigaya, Saitam | 343-0015 | Japan |
| Cosmos Clinic /ID# 164161 | Kōriyama | 963-0209 | Japan |
| Ishida Medical Clinic /ID# 166887 | Kōriyama | 963-8023 | Japan |
| Kawasaki Medical School Hosp /ID# 162906 | Kurashiki | 701-0114 | Japan |
| National Hosp Org Kure Med Cen /ID# 167689 | Kure, Hiroshima | 737-0023 | Japan |
| Kurihara Central Hospital /ID# 171047 | Kurihara | 228-0014 | Japan |
| Kuroishi Hospital /ID# 164971 | Kuroishi-aomori | 036-0541 | Japan |
| Shin Koga Clinic /ID# 164972 | Kurume | 830-0033 | Japan |
| Koga Hospital 21 /ID# 167698 | Kurume | 839-0801 | Japan |
| Hori Internal Medicine Clinic /ID# 167696 | Kushiro | 085-0005 | Japan |
| NHO Kyoto Medical Center /ID# 162910 | Kyoto | 612-0861 | Japan |
| Matsuzaki Internal Medicine Cl /ID# 164970 | Kyoto | 615-8101 | Japan |
| Gibo Hepatorogy Clinic /ID# 161766 | Matsumoto | 399-0036 | Japan |
| Kizawa Memorial Hospital /ID# 162957 | Minokamo | 505-0034 | Japan |
| Sumiyoshi Clinic Hospital /ID# 164163 | Mito | 310-0844 | Japan |
| South Miyagi Medical Center /ID# 164965 | Miyagi | 989-1253 | Japan |
| National Hospital Organization /ID# 168345 | Miyakonojō | 885-0014 | Japan |
| Miyazaki Medical Center Hospit /ID# 165279 | Miyazaki | 880-0003 | Japan |
| University of Miyazaki Hosp /ID# 166880 | Miyazaki | 889-1692 | Japan |
| Matsushita Memorial Hospital /ID# 167693 | Moriguchi-shi | 570-0096 | Japan |
| Suzuki Clinic /ID# 165264 | Nagareyama | 270-0157 | Japan |
| Meitetsu Hospital /ID# 165288 | Nagoya | 451-8511 | Japan |
| Nagoya Central Hospital /ID# 166879 | Nagoya | 453-0801 | Japan |
| Aikawa Minnano-shinryojo /ID# 164168 | Nagoya | 458-0011 | Japan |
| Meijo Hospital /ID# 164966 | Nagoya-aichi | 460-0001 | Japan |
| Nara City Hospital /ID# 162959 | Nara | 530-0025 | Japan |
| Tani Internal Medicine Clinic /ID# 164974 | Nayoro | 096-0018 | Japan |
| Ooka Clinic /ID# 161887 | Nishinomiya | 663-8124 | Japan |
| Noshiro Yamamoto Med. Assoc. /ID# 162964 | Noshiro | 016-0151 | Japan |
| Manna Clinic /ID# 169548 | Odawara | 250-0214 | Japan |
| Okayama Saiseikai Outpatient Center Hospital /ID# 159475 | Okayama | 700-0013 | Japan |
| Omuta City Hospital /ID# 164967 | Omuta | 836-0861 | Japan |
| Kita-harima Medical Center /ID# 164165 | Ono | 675-1327 | Japan |
| Onomichi Central General Hospi /ID# 162903 | Onomichi | Japan |
| Kenporen Osaka Central Hospita /ID# 164956 | Osaka | 530-0001 | Japan |
| Asai Naika /ID# 167691 | Osaka | 537-0024 | Japan |
| Osaka Inter. Cancer Institute /ID# 166889 | Osaka | 541-8567 | Japan |
| Osaka Police Hospital /ID# 161769 | Osaka | 543-0035 | Japan |
| Asai Naika Iin /ID# 164955 | Osaka | 546-0043 | Japan |
| Utajima Ueda Clinic /ID# 161894 | Osaka | 555-0012 | Japan |
| Tamai Clinic /ID# 164162 | Osaka | 557-0002 | Japan |
| Osaka Hospital /ID# 164157 | Osaka | 572-0854 | Japan |
| Oita Midical Center /ID# 164960 | Ōita | 870-0263 | Japan |
| Seko Internal Medicine Clinic /ID# 164169 | Ōtsu | 520-0802 | Japan |
| Kawazoe Internal Medicine Clin /ID# 165292 | Saga | 849-1113 | Japan |
| Saitama Citizens Medical Ctr /ID# 169550 | Saitama | 331-0054 | Japan |
| Sainokuni Higashiomiya Medical /ID# 167700 | Saitama | 331-0804 | Japan |
| Honda Internal Clinic /ID# 161767 | Saitama | 349-0115 | Japan |
| Saitama Cooperative Hospital /ID# 167697 | Saitama | Japan |
| Minamitani Clinic /ID# 160821 | Sakai | 590-0026 | Japan |
| Kaisei Hospital /ID# 164973 | Sapporo | 001-0033 | Japan |
| Sendai Kousei Hospital /ID# 162961 | Sendai | 980-0873 | Japan |
| Saka General Hospital /ID# 162962 | Shiogama-miyagi | 985-0024 | Japan |
| Saiseikai Suita Hospital /ID# 165289 | Suita | 564-0013 | Japan |
| Suita Municipal Hospital /ID# 164958 | Suita-osaka | 564-0082 | Japan |
| Kagawa Prefectural Central Hos /ID# 160816 | Takamatsu | 760-0065 | Japan |
| Sawada Hepatology & Gastro /ID# 165255 | Takaraduka | 665-0881 | Japan |
| Tenjin Tanaka Internal Medicin /ID# 166883 | Takatsuki | 569-1123 | Japan |
| Hamada Clinic /ID# 171045 | Tatebayashi | 374-0053 | Japan |
| Todachuo General Hospital /ID# 165280 | Toda-shi, Saitama | 335-0023 | Japan |
| Eastern Chiba Medical Center /ID# 165257 | Togane, Chiba | 283-0826 | Japan |
| Delta Clinic /ID# 164167 | Tokorozawa | 359-0037 | Japan |
| The Jikei University Hospital /ID# 169547 | Tokyo | 105-8461 | Japan |
| Abbott Japan /ID# 144983 | Tokyo | 108-6303 | Japan |
| Juntendo University Hospital /ID# 161771 | Tokyo | 113-8431 | Japan |
| Nippon Medical School Hospital /ID# 164164 | Tokyo | 113-8602 | Japan |
| Tokyo Metropolitan Bokutoh Hos /ID# 167686 | Tokyo | 130-8575 | Japan |
| Ohashi Medical Office /ID# 164968 | Tokyo | 173-0021 | Japan |
| Juntendo Univ Nerima Hosp /ID# 164160 | Tokyo | 177-0033 | Japan |
| JP Red Cross Musashino Hosp /ID# 162904 | Tokyo | 180-8610 | Japan |
| Toyama University Hospital /ID# 169551 | Toyoma | 930-0194 | Japan |
| Toyonaka Municipal Hospital /ID# 167692 | Toyonaka | 560-8565 | Japan |
| Ehime University Hospital /ID# 161885 | Tōon | 791-0204 | Japan |
| Mie Syokaki Clinic /ID# 161895 | TSU, MIE | 514-0062 | Japan |
| Saiseikai Utsunomiya Hospital /ID# 162958 | Utsunomiya | 321-0974 | Japan |
| Seike Clinic /ID# 166890 | Uwajima | 798-0032 | Japan |
| Saiseikai Wakayama Hospital /ID# 162954 | Wakayama | 640-8158 | Japan |
| Wakayama Rosai Hospital /ID# 165254 | Wakayama | 640-8505 | Japan |
| Tokyo Women's Medical Universi /ID# 167694 | Yachiyo | 276-0046 | Japan |
| Tohoku Central Hospital /ID# 166897 | Yamagata | 990-0064 | Japan |
| Okuda Gastrointestinal Medicin /ID# 168349 | Yamaguchi | 753-0047 | Japan |
| Kainan Hospital /ID# 164959 | Yatomi-shi | 498-0017 | Japan |
| Kumamoto Rosai Hospital /ID# 167695 | Yatsushiro-shi | Japan |
| Mie Prefectural General Medica /ID# 162963 | Yokkaichi | 510-0885 | Japan |
| Showa Univ Fujigaoka Hosp /ID# 162952 | Yokohama | 227-0043 | Japan |
| Oita University Hospital /ID# 169549 | Yufu-shi | 879-5503 | Japan |
| Yamaguchi Surgery Clinic /ID# 167704 | Yugawara | 259-0313 | Japan |
| Josai Hospital /ID# 168347 | Yūki | 307-0001 | Japan |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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