Clinical trial NCT02862106: Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
Official title: Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis B
Keywords: Chronic Hepatitis B
HBeAg positive
Therapeutic HBV Vaccine
HBV-specific Cytotoxic T Lymphocyte
Lead sponsor: Chongqing Jiachen Biotechnology Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Third Military Medical University
First posted: 2016-08-10
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period
timeFrame: Endpoint (LOCF), up to 144 weeks
Secondary outcomes:
measure: The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
timeFrame: week95,108,120,144
measure: The Proportion of Patients With Both Negative HBeAg and HBeAb.
timeFrame: week95,108,120,144
measure: The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144
timeFrame: week95,108,120,144
measure: The Proportion of Patients With Both Negative HBsAg and HBsAb.
timeFrame: week95,108,120,144
measure: The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit
timeFrame: week95,108,120,144
measure: Change From Baseline by Visit for Serum HBV DNA
timeFrame: week95,108,120,144
measure: Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales;
timeFrame: week95,108,120,144
measure: Change From Baseline by Vsit for HBeAg Titer.
timeFrame: week95,108,120,144
Other outcomes:
Locations:
city: WuHan
country: China
facility: Renmin Hosptial of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: ChangSha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: NanJing
country: China
facility: 81th Hospital of PLA
state: Jiangsu
city: XiAn
country: China
facility: TangDu Hospital
state: Shanxi
city: WenZhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: 302 Militray Hosptial of China
city: Beijing
country: China
facility: Hepatitis Institute of Peking University People's Hospital
city: ChongQing
country: China
facility: Southwest Hospital
Study officials:
affiliation: Hepatitis Institute of Peking University People's Hospital
name: Lai Wei, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: