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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
297
Proportion of treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12
Time frame: After 12 weeks of the last dose
The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV
Time frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
The proportion of Interferon (IFN) experienced subjects who achieve SVR12 with DCV/ASV/BMS-791325
Time frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
The proportion of subjects who achieve HCV RNA < LOQ TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)
Time frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
The proportion of subjects who achieve HCV RNA < LOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4, 8, 12 and 24
Time frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
On-treatment safety as measured by the frequency of Serious Adverse Event (SAEs), discontinuations due to Adverse Event (AEs), and selected Grade 3 - 4 laboratory abnormalities
based on the US National Institutes of Health Division of AIDs (DAIDS) criteria
Time frame: Approximately 48 weeks
The proportion of subjects with anemia defined as Hb < 10 g/dL on-treatment who had Hb ≥ 10 g/dL at baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Fukui-shi, Fukui, Japan
Local Institution
Fukuoka, Fukuoka, Japan
Local Institution
Kurume-shi, Fukuoka, Japan
Local Institution
Gifu, Gifu, Japan
Local Institution
Ogaki-shi, Gifu, Japan
Local Institution
Takasaki, Gunma, Japan
Local Institution
Hiroshima, Hiroshima, Japan
Local Institution
Sapporo, Hokkaido, Japan
...and 25 more locations
Time frame: Approximately 48 weeks
The proportion of subjects in each cohort who achieve SVR12 associated with HCV genotype subtype 1a vs 1b
Time frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
The proportion of subjects in each cohort who achieve SVR12 associated with IL28B Single Nucleotide Polymorphisms (SNP) status
Time frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
The proportion of cirrhotic and non-cirrhotic subjects who achieve SVR12
Time frame: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24
On-treatment safety of non-cirrhotic vs cirrhotic subjects, as measured by the frequency of SAEs, discontinuations due to AEs, and selected Grade 3 - 4 laboratory abnormalities on DAIDS criteria
Time frame: Approximately 48 weeks