A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Treatment-Naive and IFN Experienced Subjects With Genotype 1 Chronic Hepatitis C
A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Treatment-Naive and IFN Experienced Subjects With Genotype 1 Chronic Hepatitis C
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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Inclusion Criteria:
Exclusion Criteria:
Kurume-shi, Fukuoka 8300011, Japan
Ogaki-shi, Gifu 5038502, Japan
Kawasaki-shi, Kanagawa 2138587, Japan
Suita-shi, Osaka 5650871, Japan
Iruma-gun, Saitama 3500495, Japan
Bunkyo-ku, Tokyo 1138655, Japan
Minato-ku, Tokyo 1058470, Japan
Musashino-shi, Tokyo 1808610, Japan
Shinjuku-Ku, Tokyo 1608582, Japan
Chuo-shi, Yamanashi 4093898, Japan
Nishinomiya-shi, 6638501, Japan