Hepatitis C
Conditions
Brief summary
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects chronically infected with HCV genotype 1 * HCV RNA ≥ 10,000 IU/mL at screening * Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.) * Treatment-experienced subjects are eligible
Exclusion criteria
* Evidence of cirrhosis * Liver or any other organ transplant * Current or known history of cancer within 5 years prior to enrollment * Documented or suspected HCC * Evidence of decompensated liver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12 | Post-Treatment Week 12 | SVR12 is defined as HCV ribonucleic acid (RNA) \< limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND | On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24) |
| Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND | On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24 |
| Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort | Up to post treatment week 4 (±7 days) |
| Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort | Up to post treatment week 4 (±7 days) |
| Proportion of subjects in the experienced cohort with SVR12 | Follow up Week 12 |
| Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b | Post treatment week 12 |
| Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype) | Post treatment week 12 |
| Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis | Post treatment week 12 |
| Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort | Up to post treatment week 4 (±7 days) |
Countries
Australia, Canada, France, Puerto Rico, United States
Outcome results
None listed