Chronic hepatitis B
Conditions
Interventions
test group:Therapeutic Vaccinc for hepatitis B (ePA-44)
Control group:Entecavir capsules
Sponsors
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-65 years (including boundary value), regardless of gender; 2. In line with the 2018 edition of the American Academy of Hepatology research guidelines for chronic hepatitis B and the 2019 version of the guideline for chronic hepatitis B, the diagnostic criteria for chronic hepatitis B (Hepatitis B surface Antigen (HBsAg) were positive for more than 6 months), and: Hepatitis B virus DNA (HBV-DNA) was more than 2.0 x 10^4 IU/mL (105copies/mL) Hepatitis B e antigen (Hepatitis B e Antigen, HBeAg) positive, anti -HBs negative; Alanine aminotransferase (ALT) was 2-10 times of the upper limit of normal value; 3. HLA-A2 positive subjects; 4. Subjects with compensatory liver disease with the following hematological and biochemical indexes: WBC >= 3.5 x 10^9/L Neutrophils >= 1.5 x 10^9/L Platelets >= the lower limit of normal value; Hemoglobin >= 110g / L; Total bilirubin <= 1.5 times the upper limit of normal value; Albumin was not lower than the lower limit of normal value; Blood urea nitrogen did not exceed the upper limit of normal value; Creatinine did not exceed the upper limit of normal value; Prothrombin time prolongation <= 3 sec, partial thromboplastin time in the normal range; Fasting blood glucose <= 7.0mmol/l; 5. Subjects with thyroid stimulating hormone (TSH) in normal range; 6. Subjects whose alpha fetoprotein is within the normal range; 7. Subjects who understand and voluntarily sign the informed consent approved by the Ethics Committee; 8. Subjects who are able to comply with the research procedures and visit plans specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Those subjects with positive anti havigm, anti HCV, anti hdvigm or anti HEV IgM; 2. Anti cmvigm, anti ebvigm or anti HIV positive subjects; 3. Subjects whose antinuclear antibody titer is higher than the upper limit of central detection, or they are qualitatively positive; 4. Subjects of childbearing age with positive pregnancy test; 5. Subjects with liver cancer, suspected liver cancer, cirrhosis or moderate to severe liver fibrosis; 6. Subjects with the following systemic diseases or past history, or with serious diseases considered unsuitable by researchers to participate in this trial, such as: Cardiovascular system: unstable or obvious cardiovascular diseases, such as angina pectoris, recent myocardial infarction, congestive heart failure, severe hypertension, obvious arrhythmia or abnormal ECG, etc; Respiratory system: bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc; Endocrine and metabolic diseases: diabetes, poorly controlled thyroid diseases, etc. Others: autoimmune diseases, active tuberculosis, malignant diseases (such as tumor), history of nervous or mental diseases, etc. 7. Subjects who had used anti HBV drugs before the trial drugs (interferon, lamivudine, adefovir dipivoxil, entecavir and telbivudine) and immunomodulators (thymosin) were used in the first 6 months. 8. Subjects who have participated in any drug / device clinical study within 3 months before receiving the trial drug; 9. Subjects with allergic constitution or suspected allergic to the drugs used in this test; 10. Female subjects who were in pregnancy or lactation or did not take appropriate contraceptive measures 2 weeks before screening; 11. Subjects who have family planning or sperm donation or egg donation plans or are unwilling to take effective contraceptive measures (Appendix 1) during the screening period, the trial period and within 6 months after the end of the trial; 12. Subjects who had been drinking alcohol for more than five years before the screening period, and whose daily alcohol content was more than 40g for men and 20g for women, and those who had known drug dependence; 13. Subjects with a history of organ transplantation (except corneal transplantation and hair implantation); 14. There are any other factors that the researcher thinks are not suitable for this study or completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with HBeAg/anti-HBe seroconversion was followed up to the 60th week.; | — |
Countries
China
Contacts
Public ContactYi Jin
Novel Peptide Bioscience Inc.
Outcome results
None listed