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To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-790052 + BMS-650032 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-790052 | Drug | Tablets, Oral, 60 mg, daily, 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: To assess safety and tolerability based on 4 weeks safety data, as measured by related serious adverse events (SAEs) and discontinuations due to related AEs | Week 4 | |
| Part 2: To determine the proportion of subjects who achieve SVR12 (i.e., HCV RNA < 15 IU/mL at follow-up Week 12) | Post-treatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of co-administration of BMS-790052 + BMS-650032 as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities | Weeks 4, 12, end of treatment and post-treatment Week 24 | |
| The proportion of subjects who achieve RVR (defined as HCV RNA < 15 IU/mL |
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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 | Hiroshima | Hiroshima | 734-0037 | Japan | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26683763 | Derived | Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24. | |
| 23183526 |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C549273 | daclatasvir |
| C571889 | asunaprevir |
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| BMS-650032 |
| Drug |
Tablets, Oral, 1200 mg, daily, 24 weeks |
|
| Week 4 |
| The proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL | at both Weeks 4 and 12 |
| The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL | at follow-up Week 24 |
| Resistant variants associated with clinical failure | Weeks 4, 12, end of treatment and post-treatment Week 24 |
| Sapporo |
| Hokkaido |
| 060-0033 |
| Japan |
| Local Institution | Kawasaki-Shi | Kanagawa | 2138587 | Japan |
| Local Institution | Minato-Ku | Tokyo | 105-0001 | Japan |
| Derived |
| Suzuki Y, Ikeda K, Suzuki F, Toyota J, Karino Y, Chayama K, Kawakami Y, Ishikawa H, Watanabe H, Hu W, Eley T, McPhee F, Hughes E, Kumada H. Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options. J Hepatol. 2013 Apr;58(4):655-62. doi: 10.1016/j.jhep.2012.09.037. Epub 2012 Nov 23. |
| 23178977 | Derived | Karino Y, Toyota J, Ikeda K, Suzuki F, Chayama K, Kawakami Y, Ishikawa H, Watanabe H, Hernandez D, Yu F, McPhee F, Kumada H. Characterization of virologic escape in hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir. J Hepatol. 2013 Apr;58(4):646-54. doi: 10.1016/j.jhep.2012.11.012. Epub 2012 Nov 22. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |