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The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subject.
The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese Hepatitis C virus (HCV) subjects
Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Daclatasvir + Asunaprevir | Experimental | Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Naive cohort |
|
| Arm 2: Telaprevir + pegIFNα-2b + Ribavirin | Active Comparator | Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly & Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks - Naive cohort |
|
| Arm 3: Daclatasvir + Asunaprevir | Experimental | Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Relapser cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug |
| ||
| Asunaprevir |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort |
| After 12 weeks of the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with hemoglobin < 10g/dL | First 12 weeks of treatment | |
| Proportion of subjects with rash-related dermatologic events | First 12 weeks of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have;
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Nagoya | Aichi-ken | 4668560 | Japan | ||
| Local Institution |
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| Drug |
|
| Ribavirin | Drug |
|
| pegIFNα-2b | Biological |
|
| Telaprevir | Drug |
|
| Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort |
EOT = End of treatment |
| At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and post-treatment Week 24 |
| Proportion of subjects with HCV RNA target not detected in the naive cohort | eRVR = Extended rapid virologic response | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24 |
| Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort | At post-treatment Week 12 |
| Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and Week 24 |
| Proportion of subjects with HCV RNA target not detected in the relapser cohort | At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24 |
| On treatment safety, as measured by the frequency of Severe adverse events (SAEs), discontinuation and dose modification/interruption due to Adverse events (AEs), Grade 3-4 abnormalities observed from clinical laboratory tests for each treatment group | End of treatment (24 weeks) plus 7days |
| Toyoake Shi |
| Aichi-ken |
| 4701192 |
| Japan |
| Local Institution | Chiba | Chiba | 2608677 | Japan |
| Local Institution | Fukui-shi | Fukui | 9188503 | Japan |
| Local Institution | Fukuoka | Fukuoka | 8108563 | Japan |
| Local Institution | Fukuoka | Fukuoka | 8140180 | Japan |
| Local Institution | Fukuoka | Fukuoka | 8158555 | Japan |
| Local Institution | Kurume | Fukuoka | 8300011 | Japan |
| Local Institution | Gifu | Gifu | 5008513 | Japan |
| Local Institution | Ogaki-shi | Gifu | 5038502 | Japan |
| Local Institution | Takasaki | Gunma | 3700829 | Japan |
| Local Institution | Hiroshima | Hiroshima | 7340037 | Japan |
| Local Institution | Obihiro-shi | Hokkaido | 080-0016 | Japan |
| Local Institution | Sapporo | Hokkaido | 0600033 | Japan |
| Local Institution | Sapporo | Hokkaido | 0608648 | Japan |
| Local Institution | Takamatsu | Kagawa-ken | 760-8557 | Japan |
| Local Institution | Kagoshima | Kagoshima-ken | 8908520 | Japan |
| Local Institution | Kawasaki-shi | Kanagawa | 2138587 | Japan |
| Local Institution | Yokohama | Kanagawa | 2360004 | Japan |
| Local Institution | Kumamoto | Kumamoto | 8608556 | Japan |
| Local Institution | Kumamoto | Kumamoto | 8628655 | Japan |
| Local Institution | Kyoto | Kyoto | 6028566 | Japan |
| Local Institution | Sendai | Miyagi | 9808574 | Japan |
| Local Institution | Matsumoto | Nagano | 3908621 | Japan |
| Local Institution | Nagasaki | Nagasaki | 8528501 | Japan |
| Local Institution | Ōmura | Nagasaki | 8568562 | Japan |
| Local Institution | Kashihara | Nara | 6348522 | Japan |
| Local Institution | Yufu | Oita Prefecture | 8795593 | Japan |
| Local Institution | Okayama | Okayama-ken | 7008558 | Japan |
| Local Institution | Osaka | Osaka | 5400006 | Japan |
| Local Institution | Osaka | Osaka | 5438555 | Japan |
| Local Institution | Osaka | Osaka | 5458586 | Japan |
| Local Institution | Osaka-sayama-shi | Osaka | 5898511 | Japan |
| Local Institution | Suita | Osaka | 5640013 | Japan |
| Local Institution | Suita-shi | Osaka | 5650871 | Japan |
| Local Institution | Iruma-gun | Saitama | 3500495 | Japan |
| Local Institution | Saitama | Saitama | 3380001 | Japan |
| Local Institution | Izunokuni | Shizuoka | 4102295 | Japan |
| Local Institution | Shimotsuke-shi | Tochigi | 3290498 | Japan |
| Local Institution | Bunkyo-ku | Tokyo | 1138519 | Japan |
| Local Institution | Bunkyo-ku | Tokyo | 1138655 | Japan |
| Local Institution | Minato-ku | Tokyo | 1058470 | Japan |
| Local Institution | Musashino-shi | Tokyo | 1808610 | Japan |
| Local Institution | Shinagawa-ku | Tokyo | 1428666 | Japan |
| Local Institution | Yamagata | Yamagata | 9909585 | Japan |
| Local Institution | Chuo-shi | Yamanashi | 4093898 | Japan |
| Local Institution | Nagoya | 4678602 | Japan |
| Local Institution | Nishinomiya-shi | 6638501 | 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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| ID | Term |
|---|---|
| C549273 | daclatasvir |
| C571889 | asunaprevir |
| D012254 | Ribavirin |
| C486464 | telaprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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