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The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pegIFNα 2a + Ribavirin + Placebo | Experimental | pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 48 weeks Ribavirin 200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 48 weeks Placebo 0 mg Tablets, by mouth, Once daily, 24 weeks |
|
| pegIFNα 2a + Ribavirin + Daclatasvir | Experimental | pegIFNα 2a 180 µg, Solution for injection, Subcutaneous, Once weekly, 24 or 48 weeks depending on response Ribavirin 1000-1200 mg Tablets, by mouth, 400-600mg AM, 600 mg PM, 24 or 48 weeks depending on response Daclatasvir 60 mg Tablets, by mouth, Once daily, 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa 2a | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort | Week 24 post treatment follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Genotype (GT) 4 subjects with SVR24 | Week 24 post treatment follow up visit | |
| Proportion of GT 1 & 4 subjects who achieve HCV RNA < LOQ or undetectable | Week 24 post treatment follow up visit and Week 48 post treatment follow up visit for subjects who achieve Virologic response [VR] (4&12) |
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Inclusion Criteria:
Exclusion Criteria:
Infected with HCV other than GT 1 or 4
Evidence of decompensated liver disease
Documented or suspected Hepatocellular carcinoma (HCC) as evidenced by previously obtained imaging studies or liver biopsy
Evidence of a medical condition contributing to chronic liver disease other than HCV
History of chronic Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
Current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
Laboratory values:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Ribavirin | Drug |
|
|
| Placebo matching Daclatasvir | Drug |
|
| Daclatasvir | Drug |
|
|
| Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs) | Up to 48 weeks plus 30 days |
| Discontinuations due to Adverse Events (AEs) | Up to 48 weeks plus 7 days |
| Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene | Up to 72 weeks |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| C549273 | daclatasvir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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