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

Study Overview
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Brief Summary
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This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.

Official Title
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A Phase 3, Randomized, Multi-center, Active-controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Chinese Chronic Hepatitis B Patients.

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Ypeginterferon alfa-2b
* Drug: Pegasys


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 65 years. Serum HBsAg or HBV DNA positive for at least 6 months. Serum HBsAg and HBeAg are both positive, HBV DNA ≥ 20,000IU/ml at screening. 2×ULN≤ ALT ≤10×ULN at screening (ULN=upper limit of normal). Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the treatment. 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. ANC < 1500/mm3, or PLT < 90,000/mm3. Co-infection with HAV, HIV, HCV, HDV, or HEV. Both of HBsAg and anti-HBs are positive, or both of HBeAg and anti-HBe are positive at screening. Child-Pugh ≥ B, or other evidence of hepatitis decompensation (e.g.: prothrombin time prolonged more than 3 seconds, TBil > 2ULN, Alb<35g/L). Chronic hepatitis caused by any other reason except hepatitis B. Hepatocarcinoma or suffering from any other malignant tumor. Not well-controlled endocrine diseases (e.g.: thyroid dysfunction, diabetes mellitus) Significant function damage in any major organs (e.g.: heart, lung, kidney). Other Conditions which in the opinion of the investigator precluding enrollment into the study (e.g.: poor compliance).

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: Ypeginterferon Alfa-2b<br> | Drug: Ypeginterferon alfa-2b<br>* sc, qw, 48 weeks.<br>|
| Active Comparator: Pegasys<br> | Drug: Pegasys<br>* sc, qw, 48 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with HBeAg seroconversion at week72 |  | 24 weeks after the cessation of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients with HBeAg seroconversion at week 12,24,48 |  | week 12, 24, 48 from treatment starting | 
| Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72. |  | week 4, 12, 24, 48 and 72 from treatment starting | 
| Average of HBV DNA decline level at week 12, 24,48 and 72 |  | week 12, 24, 48 and 72 from treatment starting | 
| Average of HBsAg decline level at week 12, 24, 48 and 72, and Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 12, 24, 48 and 72. |  | week 12, 24, 48 and 72 from treatment starting | 
| Proportion of patients with ALT normalization at week 12,24, 48 and 72. |  | week 12, 24, 48 and 72 from treatment starting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peginterferon, HBeAg Positive, Chronic hepatitis B