Status:
COMPLETED
Phase 2 Trial of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
Lead Sponsor:
Chongqing Jiachen Biotechnology Ltd.
Collaborating Sponsors:
Third Military Medical University
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose is to evaluate efficacy and safety of therapeutic Hepatitis B Virus（HBV） vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and prov...
Detailed Description
First stage(0-76 weeks): Eligible subjects are enrolled and assigned to 3 groups randomly in a 1:1:1 ratio： 1. εPA-44 600μg group：Subcutaneous inject εPA-44 600μg at week 0, 4, 8, 12, 20, 28；Polyene...
Eligibility Criteria
Inclusion
- Aged 18-65 years, male or female
- Conforms to diagnosis standard of chronic hepatitis B according to"2005 Guideline for Prevention and Treatment of Hepatitis B", (with positive HBsAg for more than 6 months), and HBV-DNA more than 100000 copies/ml;HBeAg (+),HBsAb(-); Alanine aminotransferase（ALT） within 2 to 10 times of ULN (upper limit of normal)
- HLA-A2 positive
- Compensatory liver disease having following hematological and biochemical indicators:WBC≥3.5E+9/L; ANC≥1.5E+9/L; PLT≥80E+9/L; Hb≥110g/L; TBil≤1.5ULN; ALB ≥ lower limit of normal value; BUN (Urea)≤upper limit of normal value; Cr≤upper limit of normal value; prothrombin time(PT) elongation≤3 sec; Activated partial thromboplastin time（APTT） within normal value; Fasting blood glucose≤7.0mmol/L
- TSH within normal value
- AFP ≤20ng/ml
- 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
- Antibody of HAV IgM, HCV, HDV IgM or HEV IgM is positive
- Antibody of CMV IgM, EBV IgM or HIV is positive
- Antinuclear antibody titer\>1:160
- Hepatocarcinoma, suspected hepatocarcinoma or hepatic cirrhosis
- Has any of the following illnesses or has a severe disease inappropriate for participation in the study based on the investigator's judgment, such as: Cardiovascular system: instable or significant cardiovascular illness such as angina pectoris, heart attack of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or abnormal ECG etc.; Respiratory system: bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc.; Endocrine, metabolism diseases: diabetes mellitus, uncontrolled thyroid diseases, etc.; Others: autoimmune disorder, active tuberculosis, malignancies (e.g.tumor), neuropathic or metal illness history,etc.
- Has used anti-HBV drug (Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine) and immunomodulator (Thymic peptide,etc ) 6 months prior to the administration of study medication
- Has participated in any other drug clinical investigations within the past 3 months
- Has allergy habitus or has suspected allergy to study drug
- Female who is in pregnancy, in lactation or planning to become pregnant during the course of the study
- Has a history of alcohol abuse (Alcohol consumption for more than 5 years, with daily consumption over 40g for males and over 20g for females) and known drug dependence
- Has a history of organ transplant (except external corneal transplantation and hair transplantation)
- Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00869778
Start Date
April 1 2009
End Date
May 1 2013
Last Update
October 1 2019
Active Locations (15)
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1
The PLA Beijing Military General Hospital
Beijing, Beijing Municipality, China
2
The 2nd Affiliated Hosptial of Harbin Medical University
Harbin, Heilongjiang, China
3
Renmin Hosptial of Wuhan University
Wuhan, Hubei, China
4
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China