Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B

Study Overview
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Brief Summary
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The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.

Detailed Description
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Second stage(76-144 weeks): In this follow-up stage the trial is open designed, and all the subjects completed the first stage study(0-76 weeks) Subjects with virological response but no serological response/with serological response but no virological response/neither virological nor serological response in the first stage, and be willing to continue the this follow-up study, will be treated by εPA-44 900 μg at week 80,83,86,89,92,95,98,101,104,108,112,116,120,124,128. Subjects with both virological and serological response, will be followed-up to 144 weeks with no Adefovir Dipivoxil or εPA-44 900 μg treatment. The definition of response as below: Virological response: HBV DNA<2.93×10∧3IU/ml at 76 weeks; Serological response: serological conversion of HBeAg at 76 weeks.

Official Title
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Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Biological: εPA-44


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subjects completed the first stage study(0-76 weeks) and willing to willing to participate in the trial Uses effective contraception for subject with child-bearing potential (including females and female partners of males) Understands and signs ICF approved by EC Willing to comply with the study procedures and complete the study Exclusion Criteria: 1.Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: εPA-44 900μg group-placebo<br>These subjects from the placebo group of protocol 71006.01 InjectεPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 | Biological: εPA-44<br>* subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128<br>* Other names: Therapeutic HBV vaccine;|
| Experimental: εPA-44 900μg group-εPA-44 600μg<br>These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 | Biological: εPA-44<br>* subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128<br>* Other names: Therapeutic HBV vaccine;|
| Experimental: εPA-44 900μg group-εPA-44 900μg<br>These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 | Biological: εPA-44<br>* subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128<br>* Other names: Therapeutic HBV vaccine;|
| No Intervention: Follow-up group-placebo<br>These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only | |
| No Intervention: Follow-up group-εPA-44 600μg<br>These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only | |
| No Intervention: Follow-up group-εPA-44 900μg<br>These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period | Primary endpoint data were summarised under End of Study,using the last available post-baseline observation(Last Observation Carried Forward,LOCF) | Endpoint (LOCF), up to 144 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144 |  | week95,108,120,144 | 
| The Proportion of Patients With Both Negative HBeAg and HBeAb. |  | week95,108,120,144 | 
| The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144 |  | week95,108,120,144 | 
| The Proportion of Patients With Both Negative HBsAg and HBsAb. |  | week95,108,120,144 | 
| The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit |  | week95,108,120,144 | 
| Change From Baseline by Visit for Serum HBV DNA |  | week95,108,120,144 | 
| Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales; |  | week95,108,120,144 | 
| Change From Baseline by Vsit for HBeAg Titer. | Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values | week95,108,120,144 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis B, HBeAg positive, Therapeutic HBV Vaccine, HBV-specific Cytotoxic T Lymphocyte