Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose is to evaluate efficacy and safety of therapeutic hepatitis B virus (HBV) vaccine (mimogen-based)) Joint entecavir treatment in chronic hepatitis B patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chongqing Jiachen Biotechnology Ltd.
• Collaborator: Third Military Medical University
• Treatments: Entecavir; Vaccines

Criteria

Inclusion Criteria:

1. Aged 18-65 years, male or female;

2. Conforming 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), never have systemic treatment of anti-HBV viral ,and

• HBV-DNA ≥ 1.72×10^4 IU/ml；

• HBeAg (+), HBeAb (-)；

• ALT within 2 to 10 times of ULN (upper limits of normal);

3. HLA-A2 positive;

4. Compensatory liver disease having following hematological and biochemical parameters:

• WBC ≥ 3.5×10^9/L;

• ANC ≥ 1.5×10^9/L;

• PLT ≥ 80×10^9/L;

• Hb ≥ 100g/L;

• TBil ≤ 1.5 ULN;

• ALB not lower than low limit of normal value;

• BUN no more than high limit of normal value;

• Cr ≤ 1.5 ULN high limit of normal value;

• PT elongation ≤ 3 sec, APTT in normal value;

• Fasting blood glucose ≤ 7.0mmol/L;

5. TSH in normal value;

6. AFP test result no more than high limit of normal value;

7. Take effective contraception for subject with child-bearing potential (including females and female partners of males);

8. Understand and sign ICF approved by EC;

9. Willing to comply with the study procedures and complete the study.

Exclusion Criteria:

1. Antibodies of HCV, HDV or HIV is positive;

2. ANA titer > 1:100;

3. Decompensated liver disease (such as gullet and pylorus varicose veins, hepatic encephalopathy);

4. Have the following illness or with severe disease inappropriate to participate in the study in the view of the investigator, in 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: bronchiectasia, 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, metal, acute or chronic pancreatitis illness history, etc.

5. Have used anti-HBV drug ( Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine ) and immunomodulator ( Thymic peptide, etc ) to the administration of study medication;

6. Have allergic diathesis or have suspected allergy to εPA-44;

7. Female in pregnancy, lactation or those who plan to pregnancy during the course of the study;

8. Have 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;

9. Have history of organ transplantation (except corneal transplantation and hair transplantation);

10. Have participated in any other drug clinical investigations within 3 months;

11. Any other factors inappropriate for enroll in the study or study completion in the view of the investigator.