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The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC).
Limit of Quantitation (LOQ)
Ribonucleic acid (RNA)
End of Treatment (EOT)
Triple Direct Acting Antivirals (3DAA)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV | Experimental | DCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind) |
|
| Arm 2: DCV/ASV + Placebo for DCV 3DAA | Active Comparator | Daclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind) |
|
| DCV 3DAA | Experimental | DCV 3DAA (open label) Tablet orally twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug |
| ||
| Asunaprevir |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12 | After 12 weeks of the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV | Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 | |
| The proportion of Interferon (IFN) experienced subjects who achieve SVR12 with DCV/ASV/BMS-791325 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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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 | 466-8560 | Japan | ||
| Local Institution |
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|
| DCV 3DAA | Drug |
|
|
| Placebo for DCV 3DAA | Other |
|
| Placebo for Daclatasvir | Other |
|
| Placebo for Asunaprevir | Other |
|
| Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 |
| The proportion of subjects who achieve HCV RNA < LOQ TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24) | Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 |
| The proportion of subjects who achieve HCV RNA < LOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4, 8, 12 and 24 | Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 |
| On-treatment safety as measured by the frequency of Serious Adverse Event (SAEs), discontinuations due to Adverse Event (AEs), and selected Grade 3 - 4 laboratory abnormalities | based on the US National Institutes of Health Division of AIDs (DAIDS) criteria | Approximately 48 weeks |
| The proportion of subjects with anemia defined as Hb < 10 g/dL on-treatment who had Hb ≥ 10 g/dL at baseline | Approximately 48 weeks |
| The proportion of subjects in each cohort who achieve SVR12 associated with HCV genotype subtype 1a vs 1b | Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 |
| The proportion of subjects in each cohort who achieve SVR12 associated with IL28B Single Nucleotide Polymorphisms (SNP) status | Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 |
| The proportion of cirrhotic and non-cirrhotic subjects who achieve SVR12 | Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24 |
| On-treatment safety of non-cirrhotic vs cirrhotic subjects, as measured by the frequency of SAEs, discontinuations due to AEs, and selected Grade 3 - 4 laboratory abnormalities on DAIDS criteria | Approximately 48 weeks |
| Nagoya |
| Aichi-ken |
| 4678602 |
| Japan |
| Local Institution | Fukui-shi | Fukui | 9188503 | Japan |
| Local Institution | Fukuoka | Fukuoka | 8108563 | Japan |
| Local Institution | Kurume-shi | 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 | 7348551 | Japan |
| Local Institution | Sapporo | Hokkaido | 0600033 | Japan |
| Local Institution | Sapporo | Hokkaido | 0608648 | Japan |
| Local Institution | Kobe | Hyōgo | 6500047 | Japan |
| Local Institution | Kanazawa | Ishikawa-ken | 9208641 | Japan |
| Local Institution | Takamatsu | Kagawa-ken | 7608557 | Japan |
| Local Institution | Kagoshima | Kagoshima-ken | 8908520 | Japan |
| Local Institution | Kawasaki-shi | Kanagawa | 2138587 | Japan |
| Local Institution | Yokohama | Kanagawa | 2320024 | Japan |
| Local Institution | Kumamoto | Kumamoto | 8628655 | Japan |
| Local Institution | Kyoto | Kyoto | 6028566 | Japan |
| Local Institution | Miyazaki | Miyazaki | 8800003 | Japan |
| Local Institution | Kashihara | Nara | 6348522 | Japan |
| Local Institution | Okayama | Okayama-ken | 7008558 | Japan |
| Local Institution | Osaka | Osaka | 5438555 | Japan |
| Local Institution | Osaka | Osaka | 5458586 | Japan |
| Local Institution | Suita | Osaka | 5640013 | Japan |
| Local Institution | Suita-shi | Osaka | 5650871 | Japan |
| Local Institution | Saga | Saga-ken | 8408571 | Japan |
| Local Institution | Iruma-gun | Saitama | 3500495 | Japan |
| Local Institution | Bunkyo-ku | Tokyo | 1138655 | Japan |
| Local Institution | Minato-ku | Tokyo | 1058470 | Japan |
| Local Institution | Musashino-shi | Tokyo | 1808610 | Japan |
| Local Institution | Shinjuku-Ku | Tokyo | 1608582 | Japan |
| Local Institution | Yamagata | Yamagata | 9909585 | Japan |
| Local Institution | Chuo-shi | Yamanashi | 4093898 | 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 |
| C587012 | 8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide |
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