Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclatasvir + Asunaprevir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-790052 (Daclatasvir) | Drug | Tablets, Oral, 60mg, Once daily, 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Antiviral activity, as determined by the proportion of subjects with SVR24 | SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment) | After 24 weeks of the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below lower limit of quantitation (LLOQ) target detected or not detected | Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12 | |
| Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients who have -
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27287851 | Derived | Hernandez D, Yu F, Huang X, Kirov S, Pant S, McPhee F. Impact of Pre-existing NS5A-L31 or -Y93H Minor Variants on Response Rates in Patients Infected with HCV Genotype-1b Treated with Daclatasvir/Asunaprevir. Adv Ther. 2016 Jul;33(7):1169-79. doi: 10.1007/s12325-016-0354-1. Epub 2016 Jun 10. | |
| 26683763 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BMS-650032 (Asunaprevir) |
| Drug |
Capsules, Oral, 100mg, Twice daily, 24 weeks |
|
| Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24 |
| Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), AEs by intensity and laboratory abnormalities by toxicity grade | End of treatment plus 7 days |
| Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)] | Follow-up Week 24 |
| Chiba |
| Chiba |
| 2608677 |
| Japan |
| Local Institution | Fukuoka | Fukuoka | 8108563 | Japan |
| Local Institution | Kurume | Fukuoka | 8300011 | Japan |
| Local Institution | Ogaki-shi | Gifu | 5038502 | Japan |
| Local Institution | Hiroshima | Hiroshima | 7340037 | Japan |
| Local Institution | Sapporo | Hokkaido | 0600033 | Japan |
| Local Institution | Amagasaki-shi | Hyōgo | 6608511 | 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 | Sendai | Miyagi | 9808574 | Japan |
| Local Institution | Okayama | Okayama-ken | 7008558 | 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 | 350-0495 | 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 | Chuo-shi | Yamanashi | 4093898 | Japan |
| 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. |
| 24604476 | Derived | Kumada H, Suzuki Y, Ikeda K, Toyota J, Karino Y, Chayama K, Kawakami Y, Ido A, Yamamoto K, Takaguchi K, Izumi N, Koike K, Takehara T, Kawada N, Sata M, Miyagoshi H, Eley T, McPhee F, Damokosh A, Ishikawa H, Hughes E. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology. 2014 Jun;59(6):2083-91. doi: 10.1002/hep.27113. Epub 2014 Apr 1. |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C549273 | daclatasvir |
| C571889 | asunaprevir |
Not provided
Not provided
Not provided