Chronic Hepatitis C Virus Clinical Trial
Official title:
Drug Use-Results Survey in Patients Infected With Hepatitis C Virus Genotype 2
| NCT number | NCT02945228 |
| Other study ID # | P15-764 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 26, 2016 |
| Est. completion date | July 26, 2019 |
| Verified date | June 2020 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 449 |
| Est. completion date | July 26, 2019 |
| Est. primary completion date | July 26, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Kato Michio Hepatology Clinic /ID# 159476 | Amagasaki, Hyogo | |
| Japan | Aomori Prefectural Central Hos /ID# 160822 | Aomori-shi | |
| Japan | Mantani Clinic /ID# 168353 | Arida | |
| Japan | Japanese Red Cross Asahikawa /ID# 165265 | Asahikawa | |
| Japan | Asahikawa City Hospital /ID# 167703 | Asahikawa-shi | |
| Japan | Chiba University Hospital /ID# 160875 | Chiba | |
| Japan | National Hospital Organization /ID# 168346 | Chiba | |
| Japan | Seirei Sakura Citizen Hospital /ID# 166896 | Chiba | |
| Japan | Kenseido-iin /ID# 164166 | Chichibu | |
| Japan | University of Yamanashi Hospital /ID# 161770 | Chuo-shi | Yamanashi |
| Japan | Fuji City General Hospital /ID# 165278 | Fuji | |
| Japan | Kusunoki Hospital /ID# 158119 | Fujioka | Gunma |
| Japan | Fukui Prefectural Hospital /ID# 168344 | Fukui | |
| Japan | Fukui Prefectural Hospital /ID# 169552 | Fukui | |
| Japan | University of Fukui Hospital /ID# 166933 | Fukui | |
| Japan | Chihaya Hospital /ID# 161893 | Fukuoka | |
| Japan | NHO Kyushu Medical Center /ID# 162956 | Fukuoka-shi | Fukuoka |
| Japan | Morichika Internal Medicine /ID# 168351 | Fukuyama | |
| Japan | Fukuyama City Hospital /ID# 161889 | Fukuyama-shi | Hiroshima |
| Japan | NHO Fukuyama Medical Center /ID# 162909 | Fukuyama-shi | Hiroshima |
| Japan | Gifu Municipal Hospital /ID# 165287 | Gifu | |
| Japan | Shiroyama Hospital /ID# 164963 | Habikino-osaka | |
| Japan | Aomori Rosai Hospital /ID# 167702 | Hachinohe | |
| Japan | Hamamatsu University Hospital /ID# 171048 | Hamamatsu | Shizuoka |
| Japan | Tamakoshi Clinic /ID# 165282 | Hamamatsu | |
| Japan | Higashihiroshima Medical Ctr /ID# 168343 | Higashihiroshima | |
| Japan | Mito Medical Center /ID# 171046 | Higashiibaraki-gun | |
| Japan | Higashiomicity Notogawa Hosp /ID# 161891 | Higashiomi, Shiga | |
| Japan | Shin-ishikiri Clinic /ID# 169643 | Higashiosaka | |
| Japan | Wakakusa Daiichi Hospital /ID# 166882 | Higashiosaka | |
| Japan | Hiroshima Red Cross Hosp Atomi /ID# 162912 | Hiroshima | |
| Japan | Hiroshima University Hospital /ID# 160815 | Hiroshima | |
| Japan | Hiroshima-Nishi Medical Center /ID# 169642 | Hiroshima | |
| Japan | Koyo New Town Hospital /ID# 161890 | Hiroshima | |
| Japan | Taishi Hospital /ID# 165291 | Hyogo | |
| Japan | Iizuka Hospital /ID# 161886 | Iizuka | |
| Japan | Ikeda Municipal Hospital /ID# 160814 | Ikeda | |
| Japan | Tokyo Med Uni Ibaraki Med Ctr /ID# 162955 | Inashiki | |
| Japan | Nippon Med Chiba Hokusoh Hosp /ID# 162902 | Inzai | |
| Japan | Saitama Medical University Hos /ID# 161768 | Iruma-gun | |
| Japan | Itoigawa Sogo Hospital /ID# 166884 | Itoigawa | |
| Japan | Kamiiwade Internal Med-Neuro /ID# 166881 | Iwade | |
| Japan | Nanpuh Hospital /ID# 168348 | Kagoshima-shi | Kagoshima |
| Japan | Kaizuka City Hospital /ID# 165256 | Kaizuka | |
| Japan | Kamisu Saiseikai Hospital /ID# 167701 | Kamisu | |
| Japan | Hiratsuka City Hospital /ID# 161884 | Kanagawa | |
| Japan | Kiyokawa Hospital /ID# 164961 | Kanagawa | |
| Japan | Niwa Hospital /ID# 167684 | Kanagawa | |
| Japan | Fuji Clinic /ID# 160820 | Kanonji | |
| Japan | Ibaraki Prefectural Cent. Hosp /ID# 164962 | Kasama | |
| Japan | The Jikei Univ. Kashiwa Hosp. /ID# 166888 | Kashiwa-shi | |
| Japan | Kashiwazaki General Hospital a /ID# 168352 | Kashiwazaki | |
| Japan | Kawase Clinic /ID# 164957 | Kasugai | |
| Japan | Hirose Clinic /ID# 167699 | Kawagoe | |
| Japan | Sekishindo Hospital /ID# 162960 | Kawagoe | |
| Japan | Saitama Medical Center, Saitama Medical University /ID# 162911 | Kawagoe-shi | Saitama |
| Japan | Kawaguchi Municipal Medical Ce /ID# 165270 | Kawaguchi | |
| Japan | Kawasaki Municipal Tama Hospit /ID# 165267 | Kawasaki | |
| Japan | St. Marianna University School of Medicine Hospital /ID# 160876 | Kawasaki | Kanagawa |
| Japan | Kanto Rosai Hospital /ID# 165258 | Kawasaki-shi, Kanagawa | |
| Japan | Kishiwada Tokushukai Hospital /ID# 164964 | Kishiwada, Osaka | |
| Japan | Kokura Kinen Hospital /ID# 164969 | Kitakyusyu | |
| Japan | Kitasato University Medical Ce /ID# 158120 | Kitamoto | |
| Japan | Kobe Adventist Hospital /ID# 161897 | Kobe | |
| Japan | Kobe Asahi Hospital /ID# 161896 | Kobe | |
| Japan | Tokyo Jikei Daisan Hospital /ID# 164159 | Komae-shi | Tokyo |
| Japan | Konan Kosei Hospital /ID# 165277 | Konan-shi | |
| Japan | Cosmos Clinic /ID# 164161 | Koriyama | |
| Japan | Ishida Medical Clinic /ID# 166887 | Koriyama | |
| Japan | Dokkyo Medical University Saitama Medical Center /ID# 162907 | Koshigaya | Saitama |
| Japan | Hanada Internal Medicine Clin /ID# 165266 | Koshigaya, Saitam | |
| Japan | Kumamoto Shinto General Hospital /ID# 165275 | Kumamoto-shi | Kumamoto |
| Japan | Kumamoto University Hospital /ID# 167048 | Kumamoto-shi | Kumamoto |
| Japan | Kawasaki Medical School Hosp /ID# 162906 | Kurashiki | |
| Japan | National Hosp Org Kure Med Cen /ID# 167689 | Kure, Hiroshima | |
| Japan | Kurihara Central Hospital /ID# 171047 | Kurihara | |
| Japan | Kuroishi Hospital /ID# 164971 | Kuroishi-aomori | |
| Japan | Koga Hospital 21 /ID# 167698 | Kurume | |
| Japan | Shin Koga Clinic /ID# 164972 | Kurume | |
| Japan | Kurume University Hospital /ID# 164158 | Kurume-shi | Fukuoka |
| Japan | Hori Internal Medicine Clinic /ID# 167696 | Kushiro | |
| Japan | Matsuzaki Internal Medicine Cl /ID# 164970 | Kyoto | |
| Japan | NHO Kyoto Medical Center /ID# 162910 | Kyoto | |
| Japan | Gibo Hepatorogy Clinic /ID# 161766 | Matsumoto | |
| Japan | Matsuyama Red Cross Hosp /ID# 162953 | Matsuyama | Ehime |
| Japan | Kizawa Memorial Hospital /ID# 162957 | Minokamo | |
| Japan | Sumiyoshi Clinic Hospital /ID# 164163 | Mito | |
| Japan | South Miyagi Medical Center /ID# 164965 | Miyagi | |
| Japan | National Hospital Organization /ID# 168345 | Miyakonojo | |
| Japan | Miyazaki Medical Center Hospit /ID# 165279 | Miyazaki | |
| Japan | University of Miyazaki Hosp /ID# 166880 | Miyazaki-shi | |
| Japan | Matsushita Memorial Hospital /ID# 167693 | Moriguchi-shi | |
| Japan | Aichi Medical University Hosp /ID# 161892 | Nagakute | Aichi |
| Japan | Suzuki Clinic /ID# 165264 | Nagareyama | |
| Japan | Aikawa Minnano-shinryojo /ID# 164168 | Nagoya | |
| Japan | Meitetsu Hospital /ID# 165288 | Nagoya | |
| Japan | Meijo Hospital /ID# 164966 | Nagoya-aichi | |
| Japan | Nagoya Central Hospital /ID# 166879 | Nagoya-shi | |
| Japan | Nara City Hospital /ID# 162959 | Nara | |
| Japan | Tani Internal Medicine Clinic /ID# 164974 | Nayoro | |
| Japan | Ooka Clinic /ID# 161887 | Nishinomiya | |
| Japan | The Hospital of Hyogo College of Medicine /ID# 162913 | Nishinomiya-shi | Hyogo |
| Japan | Noshiro Yamamoto Med. Assoc. /ID# 162964 | Noshiro | |
| Japan | Manna Clinic /ID# 169548 | Odawara | |
| Japan | Oita Midical Center /ID# 164960 | Oita | |
| Japan | Okayama Saiseikai Outpatient Center Hospital /ID# 159475 | Okayama | |
| Japan | Okayama University Hospital /ID# 165268 | Okayama-shi | Okayama |
| Japan | Omuta City Hospital /ID# 164967 | Omuta | |
| Japan | Kita-harima Medical Center /ID# 164165 | ONO | |
| Japan | Onomichi Central General Hospi /ID# 162903 | Onomichi | |
| Japan | Asai Naika /ID# 167691 | Osaka | |
| Japan | Asai Naika Iin /ID# 164955 | Osaka | |
| Japan | Kenporen Osaka Central Hospita /ID# 164956 | Osaka | |
| Japan | Osaka Hospital /ID# 164157 | Osaka | |
| Japan | Osaka Inter. Cancer Institute /ID# 166889 | Osaka | |
| Japan | Osaka Police Hospital /ID# 161769 | Osaka | |
| Japan | Tamai Clinic /ID# 164162 | Osaka | |
| Japan | Utajima Ueda Clinic /ID# 161894 | Osaka | |
| Japan | Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 167688 | Osaka-shi | Osaka |
| Japan | Osaka City University Hospital /ID# 165290 | Osaka-shi | Osaka |
| Japan | Osaka Red Cross Hospital /ID# 161888 | Osaka-shi | Osaka |
| Japan | Seko Internal Medicine Clinic /ID# 164169 | Otsu | |
| Japan | Kawazoe Internal Medicine Clin /ID# 165292 | Saga | |
| Japan | Honda Internal Clinic /ID# 161767 | Saitama | |
| Japan | Sainokuni Higashiomiya Medical /ID# 167700 | Saitama | |
| Japan | Saitama Citizens Medical Ctr /ID# 169550 | Saitama | |
| Japan | Saitama Cooperative Hospital /ID# 167697 | Saitama | |
| Japan | Minamitani Clinic /ID# 160821 | Sakai | |
| Japan | Kaisei Hospital /ID# 164973 | Sapporo | |
| Japan | Sendai Kousei Hospital /ID# 162961 | Sendai | |
| Japan | Tokyo Women's Medical University Hospital /ID# 167685 | Shinjuku-ku | Tokyo |
| Japan | Saka General Hospital /ID# 162962 | Shiogama-miyagi | |
| Japan | Saiseikai Suita Hospital /ID# 165289 | Suita | |
| Japan | Suita Municipal Hospital /ID# 164958 | Suita-osaka | |
| Japan | Kagawa Prefectural Central Hos /ID# 160816 | Takamatsu | |
| Japan | Sawada Hepatology & Gastro /ID# 165255 | Takaraduka | |
| Japan | National Hospital Organization Takasaki General Medical Center /ID# 160877 | Takasaki-shi | Gunma |
| Japan | Tenjin Tanaka Internal Medicin /ID# 166883 | Takatsuki | |
| Japan | Osaka Medical College Hospital /ID# 162908 | Takatsuki -shi | Osaka |
| Japan | Hamada Clinic /ID# 171045 | Tatebayashi | |
| Japan | Todachuo General Hospital /ID# 165280 | Toda-shi, Saitama | |
| Japan | Eastern Chiba Medical Center /ID# 165257 | Togane, Chiba | |
| Japan | Delta Clinic /ID# 164167 | Tokorozawa | |
| Japan | Abbott Japan /ID# 144983 | Tokyo | |
| Japan | JP Red Cross Musashino Hosp /ID# 162904 | Tokyo | |
| Japan | Juntendo Univ Nerima Hosp /ID# 164160 | Tokyo | |
| Japan | Juntendo University Hospital /ID# 161771 | Tokyo | |
| Japan | Nippon Medical School Hospital /ID# 164164 | Tokyo | |
| Japan | Ohashi Medical Office /ID# 164968 | Tokyo | |
| Japan | The Jikei University Hospital /ID# 169547 | Tokyo | |
| Japan | Tokyo Metropolitan Bokutoh Hos /ID# 167686 | Tokyo | |
| Japan | Ehime University Hospital /ID# 161885 | Toon | |
| Japan | Toyama University Hospital /ID# 169551 | Toyoma | |
| Japan | Toyonaka Municipal Hospital /ID# 167692 | Toyonaka | |
| Japan | Mie Syokaki Clinic /ID# 161895 | Tsu, Mie | |
| Japan | Saiseikai Utsunomiya Hospital /ID# 162958 | Utsunomiya | |
| Japan | Seike Clinic /ID# 166890 | Uwajima | |
| Japan | Saiseikai Wakayama Hospital /ID# 162954 | Wakayama | |
| Japan | Wakayama Rosai Hospital /ID# 165254 | Wakayama-shi | |
| Japan | Tokyo Women's Medical Universi /ID# 167694 | Yachiyo | |
| Japan | Tohoku Central Hospital /ID# 166897 | Yamagata | |
| Japan | Okuda Gastrointestinal Medicin /ID# 168349 | Yamaguchi | |
| Japan | Kainan Hospital /ID# 164959 | Yatomi-shi | |
| Japan | Kumamoto Rosai Hospital /ID# 167695 | Yatsushiro-shi | |
| Japan | Mie Prefectural General Medica /ID# 162963 | Yokkaichi | |
| Japan | Yokohama City Univ Medical Ctr /ID# 162905 | Yokohama | Kanagawa |
| Japan | Showa Univ Fujigaoka Hosp /ID# 162952 | Yokohama-shi | |
| Japan | Oita University Hospital /ID# 169549 | Yufu-shi | |
| Japan | Yamaguchi Surgery Clinic /ID# 167704 | Yugawara | |
| Japan | Josai Hospital /ID# 168347 | Yuki |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | |
| Secondary | 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 | |
| Secondary | Percentage of Participants with Virologic Failure After Treatment (relapse) | 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 | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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