Hepatitis C
Conditions
Brief summary
To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.
Detailed description
Masking is Double blind for RBV: two or more parties are unaware of the intervention assignment.
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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 * Subjects with compensated cirrhosis * HCV RNA ≥ 10,000 IU/mL at screening * Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV Direct Acting Antivirals (DAA) (protease, polymerase inhibitor, etc.) * Treatment-experienced subjects are eligible including exposure to anti-HCV agents of a mechanistic class other than those contained in the Daclatasvir (DCV) / Asunaprevir (ASV) /BMS-791325 triple regimen is permitted. Examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5B (NS5B) polymerase, inhibitors of cyclophilin, or inhibitors of microRNA.
Exclusion criteria
* Subjects without cirrhosis * Liver or any other organ transplant * Current or known history of cancer within 5 years prior to screening * Documented or suspected hepatocellular carcinoma(HCC) * Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12) | Post treatment 12 week | SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) \< Limit of Quantification (LOQ) target detected or target not detected (LOQ TD/TND) |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects in each arm who achieve HCV RNA < LOQ TD/TND | Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24) |
| Proportion of subjects in each arm who achieve HCV RNA < LOQ TND | Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8), 12 (SVR12) and 24 (SVR24) |
| Safety as measured by frequency of Serious Adverse Events(SAEs)and discontinuations due to Adverse Events(AEs) | Up to end of treatment (week 12) + 7 days |
| Proportion of treated subjects in each of the experienced arms with SVR12 | Post treatment 12 Week |
| Differences in rates of selected Grade 3 - 4 laboratory test result abnormalities | Up to end of treatment (week 12) + 7 days |
| Proportion of subjects achieving SVR12 associated with HCV geno subtype 1a vs 1b | Post treatment 12 Week |
| Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype) | Post treatment 12 Week |
| Proportion of subjects with anemia defined as Hg < 10 g/dL on-treatment and Hg ≥ 10 g/dL at baseline in each arm within each cohort | Up to end of treatment (week 12) + 7 days |
Countries
Australia, Canada, France, United States
Outcome results
None listed