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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-03-31

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.

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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)

1. 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.
2. 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:

1. Virological response: HBV DNA\<2.93×10∧3IU/ml at 76 weeks;
2. Serological response: serological conversion of HBeAg at 76 weeks.

Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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εPA-44 900μg group-placebo

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

Group Type EXPERIMENTAL

εPA-44

Intervention Type BIOLOGICAL

subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128

εPA-44 900μg group-εPA-44 600μg

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

Group Type EXPERIMENTAL

εPA-44

Intervention Type BIOLOGICAL

subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128

εPA-44 900μg group-εPA-44 900μg

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

Group Type EXPERIMENTAL

εPA-44

Intervention Type BIOLOGICAL

subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128

Follow-up group-placebo

These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only

Group Type NO_INTERVENTION

No interventions assigned to this group

Follow-up group-εPA-44 600μg

These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only

Group Type NO_INTERVENTION

No interventions assigned to this group

Follow-up group-εPA-44 900μg

These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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εPA-44

subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128

Intervention Type BIOLOGICAL

Other Intervention Names

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Therapeutic HBV vaccine

Eligibility Criteria

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Inclusion Criteria

1. The subjects completed the first stage study(0-76 weeks) and willing to willing to participate in the trial
2. Uses effective contraception for subject with child-bearing potential (including females and female partners of males)
3. Understands and signs ICF approved by EC
4. Willing to comply with the study procedures and complete the study