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

Chongqing Jiachen Biotechnology

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis B

Treatments: Biological: εPA-44

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02862106

71006.01-2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 209 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

1.Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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209 participants in 6 patient groups

εPA-44 900μg group-placebo

Experimental group

Description:

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

Treatment:

Biological: εPA-44

εPA-44 900μg group-εPA-44 600μg

Experimental group

Description:

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

Treatment:

Biological: εPA-44

εPA-44 900μg group-εPA-44 900μg

Experimental group

Description:

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

Treatment:

Biological: εPA-44

Follow-up group-placebo

No Intervention group

Description:

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

Follow-up group-εPA-44 600μg

No Intervention group

Description:

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

Follow-up group-εPA-44 900μg

No Intervention group

Description:

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