A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

Study Overview
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Brief Summary
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This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.

Official Title
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A Study on Optimizing the Treatment in HBeAg Positive CHB Patients With Response Guide Treatment (RGT) Method.

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: Adefovir
* Drug: peginterferon alfa-2a [PEGASYS]
* Drug: peginterferon alfa-2a [PEGASYS]
* Drug: peginterferon alfa-2a [PEGASYS]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients >/=18 years of age HBeAg positive chronic hepatitis B Compensated liver disease Exclusion Criteria: Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start Antiviral, anti-neoplastic or immunomodulatory treatment Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV Evidence of decompensated liver disease Chronic liver disease other than viral hepatitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: A<br> | Drug: peginterferon alfa-2a [PEGASYS]<br>* Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks<br>|
| Experimental: B<br> | Drug: peginterferon alfa-2a [PEGASYS]<br>* Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks<br>|
| Experimental: C<br> | Drug: peginterferon alfa-2a [PEGASYS]<br>* Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks<br>|
| Experimental: D<br> | Drug: Adefovir<br>* Adefovir 10 mg po once daily for 36 weeks<br>Drug: peginterferon alfa-2a [PEGASYS]<br>* Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction) |  | Weeks 72, 96, 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml |  | Weeks 24, 48, 72, 96, 120 | 
| Safety: Adverse Events |  | From baseline to Week 120 |