Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B

Study Overview
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Brief Summary
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This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys 180mcg/week as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate pharmacokinetic data of Ypeginterferon alfa-2b in hepatitis B patients to satisfy regulatory requirements.

Official Title
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A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Patients With Chronic Hepatitis B

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Ypeginterferon alfa-2b
* Drug: Peginterferon alfa-2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:18 60 years. Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment. Serum HBsAg positive for at least 6 months. Serum HBeAg positive with HBV DNA ≥20,000IU/ml. 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal). Exclusion Criteria: Pregnant or lactating women. Mental disorder or physical disability. Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months. WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3. Co-infection with HAV, HIV, HCV, HDV, HEV. Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening. Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease. Evidence of hepatic decompensation. History of hypothyroidism or current treatment for thyroid disease. Uncontrolled significant chronic medical conditions other than chronic hepatitis B, or other conditions which in the opinion of the investigator preclude enrollment into the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Group 1<br>Ypeginterferon alfa-2b 90mcg per week | Drug: Ypeginterferon alfa-2b<br>* sc, qw, for 48 weeks.<br>|
| Experimental: Group 2<br>Ypeginterferon alfa-2b 135mcg per week | Drug: Ypeginterferon alfa-2b<br>* sc, qw, for 48 weeks.<br>|
| Experimental: Group 3<br>Ypeginterferon alfa-2b 180mcg per week | Drug: Ypeginterferon alfa-2b<br>* sc, qw, for 48 weeks.<br>|
| Active Comparator: Group 4<br>Pegasys 180mcg per week | Drug: Peginterferon alfa-2a<br>* sc, qw, for 48 weeks.<br>* Other names: Pegasys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Average of HBV DAN decline level at week 24. Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24. | week 24 from treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Average of HBV DNA decline level at week 12, 48 and 72. Proportion of patients with HBV DNA undetectable at week 48 and 72. Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 48 and 72. Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 48 and 72. Proportion of patients with ALT normalization at week 24 and 48. | week 12, 24, 48 from treatment start and week 24 after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peginterferon, interferon, Pegasys, HBV, Hepatitis B, HBeAg positive