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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hepatitis C virus ribonucleic acid (HCV RNA) levels | HCV RNA levels in plasma | 60 months after completion of the 2D treatment in M12-536 or M13-004 study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Paritaprevir in Non-structural Viral Protein 3 (NS3) | For approximately 5 years | |
| Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Ombitasvir in Non-structural Viral Protein 5A (NS5A) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who were treated in Study M12-536 or M13-004 with 2D regimen (ombitasvir/ paritaprevir/ritonavir) and completed 48 weeks of follow-up.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya City University Hospital /ID# 157439 | Nagoya | Aichi-ken | 467-8602 | Japan | ||
| Matsuyama Red Cross Hospital /ID# 152125 |
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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| For approximately 5 years |
| Percentage of participants with hepatocellular carcinoma | Up to 60 month after completion of the 2D treatment in M12-536 or M13-004 |
| Number of participants with serious adverse events (SAEs) | All serious adverse events will be monitored during the observation period. | Up to 60 month after completion of the 2D treatment in M132-536 or M13-004 study |
| Hepatitis C virus ribonucleic acid (HCV RNA) levels | HCV RNA levels in plasma | 18, 24, 30, 36, 42, 48, 52 months after completion of the 2D treatment in M12-536 or M13-004 study |
| Matsuyama |
| Ehime |
| 790-8524 |
| Japan |
| National Hospital Organization Kyushu Medical Center /ID# 161759 | Fukuoka | Fukuoka | 810-8563 | Japan |
| Fukuoka University Hospital /ID# 155965 | Fukuoka | Fukuoka | 814-0180 | Japan |
| Kurume University Hospital /ID# 152123 | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Ogaki Municipal Hospital /ID# 158105 | Ogaki-shi | Gifu | 503-8502 | Japan |
| Gunma University Hospital /ID# 158118 | Maebashi | Gunma | 371-8511 | Japan |
| National Hospital Organization Takasaki General Medical Center /ID# 152128 | Takasaki-shi | Gunma | 370-0829 | Japan |
| Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 152178 | Hiroshima | Hiroshima | 730-8619 | Japan |
| Hiroshima University Hospital /ID# 152232 | Hiroshima | Hiroshima | 734-8551 | Japan |
| Obihiro kosei Hospital /ID# 157437 | Obihiro-shi | Hokkaido | 080-0024 | Japan |
| Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 153019 | Sapporo | Hokkaido | 060-0033 | Japan |
| Hitachi General Hospital /ID# 160800 | Hitachi-shi | Ibaraki | 317-0077 | Japan |
| Duplicate_Kanazawa University Hospital /ID# 152226 | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Kagawa University Hospital /ID# 153548 | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| Duplicate_Yokohama City University Medical Center /ID# 159474 | Yokohama | Kanagawa | 232-0024 | Japan |
| Yokohama City University Hospital /ID# 165252 | Yokohama | Kanagawa | 236-0004 | Japan |
| Kumamoto Shinto General Hospital /ID# 150061 | Kumamoto | Kumamoto | 8628655 | Japan |
| Okayama University Hospital /ID# 150060 | Okayama | Okayama-ken | 700-8558 | Japan |
| Osaka City General Hospital /ID# 152126 | Osaka | Osaka | 534-0021 | Japan |
| Japanese Red Cross Osaka Hospital /ID# 155964 | Osaka | Osaka | 543-8555 | Japan |
| Saga University Hospital /ID# 161757 | Saga | Saga-ken | 849-8501 | Japan |
| Saitama Medical University Hospital /ID# 153544 | Iruma-gun | Saitama | 350-0451 | Japan |
| Hamamatsu University Hospital /ID# 152176 | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Dokkyo Medical University Hospital /ID# 152225 | Shimotsuga-gun | Tochigi | 321-0293 | Japan |
| Jichi Medical University Hospital /ID# 153018 | Shimotsuke-shi | Tochigi | 329-0498 | Japan |
| Juntendo University Hospital /ID# 153545 | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| The University of Tokyo Hospital /ID# 158121 | Bunkyo-ku | Tokyo | 113-8655 | Japan |
| Toranomon Hospital /ID# 152124 | Minato-ku | Tokyo | 105-8470 | Japan |
| Kitasato University Kitasato Institute Hospital /ID# 152145 | Minato-ku | Tokyo | 108-8642 | Japan |
| Toyama Prefectural Central Hospital /ID# 164156 | Toyama | Toyama | 930-8550 | Japan |
| Yamaguchi University Hospital /ID# 166899 | Ube-shi | Yamaguchi | 755-8505 | Japan |
| University of Yamanashi Hospital /ID# 153547 | Chuo-shi | Yamanashi | 409-3821 | Japan |
| Asakura Medical Association Ho /ID# 155963 | Asakura | 838-0069 | Japan |
| Fukuiken Saiseikai Hospital /ID# 162898 | Fukui | 918-8235 | Japan |
| Gifu Municipal Hospital /ID# 152227 | Gifu | 500-8323 | Japan |
| Gifu Prefectural Genl Med Ctr /ID# 154796 | Gifu | 500-8727 | Japan |
| Ikeda Municipal Hospital /ID# 150062 | Ikeda | 563-8510 | Japan |
| Tokyo Med Uni Ibaraki Med Ctr /ID# 152127 | Inashiki | 300-0332 | Japan |
| Nippon Med Chiba Hokusoh Hosp /ID# 164155 | Inzai | 270-1613 | Japan |
| Kagoshima Uni Med and Dental /ID# 157438 | Kagoshima | 890-8520 | Japan |
| Toranomon Hospital Kajigaya /ID# 152129 | Kawasaki | 213-8587 | Japan |
| Kawasaki Municipal Tama Hospit /ID# 153546 | Kawasaki | 214-0021 | Japan |
| Ehime Prefectural Central Hosp /ID# 158106 | Matsuyama | 790-0024 | Japan |
| Kawasaki Hosp, Kawasaki Med /ID# 152180 | Okayama | 700-0821 | Japan |
| Osaka Hospital /ID# 152177 | Osaka | 572-0854 | Japan |
| Japanese Red Cross Saitama Hos /ID# 166898 | Saitama | 338-8553 | Japan |
| Saiseikai Suita Hospital /ID# 153549 | Suita | 564-0013 | Japan |
| Kagawa Prefectural Central Hos /ID# 152179 | Takamatsu | 760-0065 | Japan |
| Nat Hosp Org Minami Wakayama /ID# 153550 | Tanabe | 646-8558 | Japan |
| Toshiba General Hospital /ID# 152122 | Tokyo | 140-8522 | Japan |
| JP Red Cross Musashino Hosp /ID# 152175 | Tokyo | 180-8610 | Japan |
| Oita University Hospital /ID# 165274 | Yufu-shi | 879-5503 | Japan |
| ID | Term |
|---|---|
| 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 |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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