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

Phase 2

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
εPA-44 900μg group-εPA-44 900μg	εPA-44	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
εPA-44 900μg group-placebo	εPA-44	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
εPA-44 900μg group-εPA-44 600μg	εPA-44	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline by Vsit for HBeAg Titer.	week95,108,120,144	Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values
The Proportion of Patients With Both Negative HBeAg and HBeAb.	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
The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144	week95,108,120,144
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144	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

Locations (9): Renmin Hosptial of Wuhan University
🇨🇳
WuHan, Hubei, China
The Second Xiangya Hospital of Central South University
🇨🇳
Changsha, Hunan, China
Xiangya Hospital Central South University
🇨🇳
ChangSha, Hunan, China
81th Hospital of PLA
🇨🇳
NanJing, Jiangsu, China
TangDu Hospital
🇨🇳
XiAn, Shanxi, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳
WenZhou, Zhejiang, China
302 Militray Hosptial of China
🇨🇳
Beijing, China
Hepatitis Institute of Peking University People's Hospital
🇨🇳
Beijing, China
Southwest Hospital
🇨🇳
ChongQing, China