A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.

Official Title
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A Phase 3 Japanese Study of BMS-790052 Plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who Are Non Response to Interferon Plus Ribavirin and Interferon Based Therapy Ineligible Naive/Intolerant

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: BMS-790052 (Daclatasvir)
* Drug: BMS-650032 (Asunaprevir)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic HCV-1b infected patient HCV RNA viral load of ≥ 100,000 IU/mL at screening Ages 20 to 75 years Non-responder to Interferon plus Ribavirin therapy Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy Exclusion Criteria: Patients who have - Hepatocellular carcinoma Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV) Severe or uncontrollable complication

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daclatasvir + Asunaprevir<br> | Drug: BMS-790052 (Daclatasvir)<br>* Tablets, Oral, 60mg, Once daily, 24 weeks<br>Drug: BMS-650032 (Asunaprevir)<br>* Capsules, Oral, 100mg, Twice daily, 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiviral activity, as determined by the proportion of subjects with SVR24 | SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment) | After 24 weeks of the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below lower limit of quantitation (LLOQ) target detected or not detected |  | Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12 | 
| Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected |  | Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24 | 
| Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), AEs by intensity and laboratory abnormalities by toxicity grade |  | End of treatment plus 7 days | 
| Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)] |  | Follow-up Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C Virus Infection