drugset / Trial / NCT01497834
A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.
Timeline
- Start
- 2012-01
- Primary completion
- 2013-04
- Completion
- 2013-06
Publications
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asunaprevir | Small molecule | 100 mg | Oral |
| Subject | Daclatasvir | Small molecule | 60 mg | Oral |