Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B.

Study Overview
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Brief Summary
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Evaluate the safety and efficacy of Peginterferon alfa-2a following Entecavir compared with Peginterferon alfa-2a monotherapy in patient with HBeAg positive chronic hepatitis B. Increased HBeAg seroconversion rate Increased HBsAg loss rate To define the best treatment condition for chronic HBV hepatitis patients

Official Title
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A Randomized, Multi Center, Phase IIIb Open-label Study to Evaluate the Efficacy of Sequential Therapy of Peginterferon Alfa-2a(Pegasys(TM)) Following Entercavir Compared With Peginterferon Alfa-2a Monotherapy in Patient With HBeAg Positive Chronic Hepatitis B.

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: Entecavir and Pegylated interferon α-2a Sequential Treatment Group
* Drug: Pegylated interferon α-2a Monotreatment Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic hepatitis B patients with HBeAg positive, HBsAg positive, HBV DNA > 100,000 copies/ml and anti-HBs negative, serum ALT exceeding 2 X ULN but less than 10 X ULN. Exclusion Criteria: Patient infected concurrently with HCV, HDV and HIV or patient with a history of antiviral treatment for Hepatitis B or patient with hepatic decompensation.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential therapy<br>Entecavir/Baraclude(TM), 0.5mg, oral administration, once daily, for the first 12 weeks Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, from week 4 to 52 for 48 weeks | Drug: Entecavir and Pegylated interferon α-2a Sequential Treatment Group<br>* Entecavir/Baraclude(TM), 0.5mg, oral administration, once daily, for the first 12 weeks Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, from week 4 to 52 for 48 weeks<br>* Other names: Generic/Brand name: Entecavir/Baraclude(TM);|
| Active Comparator: Peginterferon alfa-2a monotherapy<br>Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks | Drug: Pegylated interferon α-2a Monotreatment Group<br>* Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks<br>* Other names: Generic/Brand name: Pegylated interferon α-2a/Pegasys(TM);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBeAg seroconversion |  | 24 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of HBsAg titer |  | 24 weeks after treatment | 
| the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml |  | 24 weeks after treatment | 
| The rate of serum HBV DNA < 300 copies |  | 24 weeks after treatment | 
| The rate of ALT normalization |  | 24 weeks after treatment | 
| The rate of HBsAg loss |  | 24 weeks after treatment |