Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients

Phase 2 Completed 51 enrolled Bristol-Myers Squibb

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care

Timeline

Start: 2009-12
Primary completion: 2010-09
Completion: 2010-09

Publications

Murakami E, Imamura M, Hayes CN, Abe H, Hiraga N, Honda Y, Ono A, Kosaka K, Kawaoka T, Tsuge M, Aikata H, Takahashi S, Miki D, Ochi H, Matsui H, Kanai A, Inaba T, McPhee F, Chayama K. Ultradeep sequencing study of chronic hepatitis C virus genotype 1 infection in patients treated with daclatasvir, peginterferon, and ribavirin. Antimicrob Agents Chemother. 2014;58(4):2105-12. doi: 10.1128/AAC.02068-13. Epub 2014 Jan 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daclatasvir	Small molecule	10 mg	Oral
Subject	Daclatasvir	Small molecule	60 mg	Oral
Background	Peginterferon alfa-2b	Protein / enzyme biologic	180 ug	Subcutaneous
Background	Ribavirin	Small molecule	600 mg	Oral
Background	Ribavirin	Small molecule	1000 mg	Oral

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients

Summary

Timeline

Publications

Drugs

Indications