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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
209
subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
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
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)
Time frame: Endpoint (LOCF), up to 144 weeks
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
Time frame: week95,108,120,144
The Proportion of Patients With Both Negative HBeAg and HBeAb.
Time frame: week95,108,120,144
The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144
Time frame: week95,108,120,144
The Proportion of Patients With Both Negative HBsAg and HBsAb.
Time frame: week95,108,120,144
The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit
Time frame: week95,108,120,144
Change From Baseline by Visit for Serum HBV DNA
Time frame: 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;
Time frame: 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
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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
Time frame: week95,108,120,144