Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

Study Overview
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Brief Summary
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The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.

Official Title
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A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1

Conditions
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Hepatitis C Infection

Intervention / Treatment
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* Drug: Daclatasvir
* Drug: Daclatasvir
* Drug: Daclatasvir
* Drug: Placebo
* Drug: Peginterferon alpha-2a
* Drug: ribavirin


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Patients chronically infected with hepatitis C virus (HCV) genotype 1 HCV RNA viral load of ≥10*5* IU/mL (100,000 IU/mL) at screening Treatment naive Key Exclusion Criteria: Women of child-bearing potential Cirrhosis Coinfection with HIV or hepatitis B virus

Ages Eligible for Study
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Minimum Age: 18 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: Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)<br>Active Comparator | Drug: Daclatasvir<br>* Tablets, oral, 3 mg, Daily, 48 weeks<br>Drug: Peginterferon alpha-2a<br>* Syringe, subcutaneous, 180 µg, Weekly, 48 weeks<br>* Other names: Pegasys;Drug: ribavirin<br>* Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks<br>* Other names: Copegus;|
| Experimental: Daclatasvir, Peginterferon alpha-2a, ribavirin (B)<br>Active Comparator | Drug: Daclatasvir<br>* Tablets, oral, 10 mg, Daily, 48 weeks<br>Drug: Peginterferon alpha-2a<br>* Syringe, subcutaneous, 180 µg, Weekly, 48 weeks<br>* Other names: Pegasys;Drug: ribavirin<br>* Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks<br>* Other names: Copegus;|
| Experimental: Daclatasvir, Peginterferon alpha-2a, ribavirin (C)<br>Active Comparator | Drug: Daclatasvir<br>* Tablets, oral, 60 mg, Daily, 48 weeks<br>Drug: Peginterferon alpha-2a<br>* Syringe, subcutaneous, 180 µg, Weekly, 48 weeks<br>* Other names: Pegasys;Drug: ribavirin<br>* Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks<br>* Other names: Copegus;|
| Active Comparator: Placebo, Peginterferon alpha-2a, ribavirin (D)<br> | Drug: Placebo<br>* Tablet, oral, 0 mg, Daily 48 weeks<br>Drug: Peginterferon alpha-2a<br>* Syringe, subcutaneous, 180 µg, Weekly, 48 weeks<br>* Other names: Pegasys;Drug: ribavirin<br>* Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 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) at Weeks 4 and 12 | eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12. | A Weeks 4 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4. | At Week 4 | 
| Percentage of Participants With Early Virologic Response (EVR) at Week 12 | EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL. | At Week 12 | 
| Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12 | cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12 | At Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antivirals