Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

Study Overview
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Brief Summary
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The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious

Official Title
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A Phase 2a Study of Daclatasvir in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Conditions
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Hepatitis C Infection

Intervention / Treatment
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* Drug: Daclatasvir
* Drug: Daclatasvir
* Drug: Placebo
* Drug: Peginterferon alfa-2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Subjects chronically infected with hepatitis C virus (HCV) genotype 1 HCV RNA viral load ≥ 10*5* IU/mL (100,000 IU/mL) at screening The current standard of care naïve or non-responder Key Exclusion Criteria: Cirrhosis HCC Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)<br>Treatment Naive | Drug: Daclatasvir<br>* Tablets, Oral, 10 mg, daily, 24-48 weeks<br>Drug: Peginterferon alfa-2a<br>* Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks<br>* Other names: Pegasys®;Drug: Ribavirin<br>* Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks<br>* Other names: Copegus®;|
| Experimental: Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)<br>Treatment Naive | Drug: Daclatasvir<br>* Tablets, Oral, 60 mg, daily, 24-48 weeks<br>Drug: Peginterferon alfa-2a<br>* Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks<br>* Other names: Pegasys®;Drug: Ribavirin<br>* Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks<br>* Other names: Copegus®;|
| Placebo Comparator: Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)<br>Treatment Naive | Drug: Placebo<br>* Tablets, Oral, 0 mg, daily, 48 weeks<br>Drug: Peginterferon alfa-2a<br>* Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks<br>* Other names: Pegasys®;Drug: Ribavirin<br>* Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks<br>* Other names: Copegus®;|
| Experimental: Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)<br>Non-Responder | Drug: Daclatasvir<br>* Tablets, Oral, 10 mg, daily, 24-48 weeks<br>Drug: Peginterferon alfa-2a<br>* Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks<br>* Other names: Pegasys®;Drug: Ribavirin<br>* Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks<br>* Other names: Copegus®;|
| Experimental: Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)<br>Non-Responder | Drug: Daclatasvir<br>* Tablets, Oral, 60 mg, daily, 24-48 weeks<br>Drug: Peginterferon alfa-2a<br>* Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks<br>* Other names: Pegasys®;Drug: Ribavirin<br>* Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks<br>* Other names: Copegus®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Extended Rapid Virologic Response (eRVR) | eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12. | From Week 4 up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Rapid Virologic Response (RVR) | RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4. | Week 4 | 
| Percentage of Participants With a Complete Early Virologic Response (cEVR) | cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12. | Week 12 | 
| Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 | SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24. | Follow up Week 12, Follow up Week 24 |