Hepatitis C Virus Infection
Conditions
Brief summary
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).
Detailed description
Limit of Quantitation (LOQ) Ribonucleic acid (RNA) End of Treatment (EOT) Triple Direct Acting Antivirals (3DAA)
Interventions
DRUGDaclatasvir
DRUGAsunaprevir
DRUGDCV 3DAA
OTHERPlacebo for DCV 3DAA
OTHERPlacebo for Daclatasvir
OTHERPlacebo for Asunaprevir
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Males and females, ≥ 20 years of age * Subjects chronically infected with HCV GT-1 * HCV RNA viral load of ≥ 100,000 IU/mL
Exclusion criteria
* Hepatocellular carcinoma * Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV) * Severe or uncontrollable complication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | After 12 weeks of the last dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV | 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 | 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) | 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 | Approximately 48 weeks | based on the US National Institutes of Health Division of AIDs (DAIDS) criteria |
| 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 | 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 HCV genotype subtype 1a vs 1b | 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 | 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 | 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 | 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 | Approximately 48 weeks | — |
Countries
Japan
Outcome results
None listed