HBeAg positive chronic hepatitis B
Conditions
Interventions
Test Group :Anti-HBV Placenta Transfer Factor Injection: 2mg/4ml, intramuscular injection, the 0-24 week, once every other day
week 24-48, 2 times / week
entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks
Control:Physiological saline injection: 2mg/4ml, intramuscular injection,the 0-24 week, once every other day, week 24-48, 2 times / week
entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 week
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-65, sex not limited; 2. patients with HBeAg positive chronic hepatitis B: Screening HBsAg positive for more than 6 months; screening HBeAg positive; screening serum HBV DNA >=1.0*10^5U/ml; 3. 2*ULN (2 times the upper limit of normal value) <ALT<10*ULN (10 times the upper limit of normal value); 4. total bilirubin <51umol/L; 5. hepatitis B virus resistance gene sequencing negative; 6. agree in the process of the study, do not participate in any other clinical studies or other anti HBV therapy; 7. before the beginning of the study, understand and sign the informed consent form approved by the ethics committee, and cooperate to conduct clinical research according to the requirements for the study.
Exclusion criteria
Exclusion criteria: 1. by the following evidences prompt suspected hepatocellular carcinoma: B ultrasound or imaging examination discover occupying lesion;B ultrasound normal but serum alpha fetoprotein (AFP) level has a continuous increasing trend; AFP >100ng/ml, and no any change after review; 2. with liver disease acute exacerbation cause a transient liver function decompensation disease or baseline with clinical performance of decompensated liver disease; 3. serum creatinine >=1.5mg/dl (>=130umol/l); 4. the serum amylase >2 times the normal reference upper limit value; 5. hemoglobin (male 1:160) or activite liver disease caused by other known or unknown reason; 7. investigators consider that may interfere with the treatment,evaluation or compliance of the subjects, including any uncontrolled clinical significance of kidneys, heart, lungs, blood vessels, neurogenic, digestive system, metabolic diseases (diabetes, hyperthyroidism, adrenal disease), immune function disorder or tumor; 8. subjects with a history of alcoholism or drug abuse,investigators consider the subjects cannot comply with this protocol or affect the results analysis; 9. pregnancy,lactation or female subjects plan to conceive or the companions of male subjects plan to conceive during the study; 10. 6 months before the study medication used immunosuppressants,immunomodulators (thymosin alpha), cytotoxic drugs; 11. 6 months before the study medication used anti HBV drug therapy (interferon, Lamivudine, Adefovir, Entecavir and Telbivudine, Tenofovir,etc); 12. plan or have had liver transplantation; 13. received other study drug treatment within 3 months prior to screening; 14. drug allergy history or allergic for Nucleoside or Nucleotide drug; 15. the subjects non compliance with the protocol or subjects exist any situation which investigators considered not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The HBeAg serum conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects for each observation point in HBV DNA titer decreased 2 logarithmic;The HBeAg disappearance rate;Normalization rate of the HBV DNA;The changes of HBeAg and HBsAg titer;The quantitative changes of anti -HBc;ALT concentration;The seroconversion rate, resistance mutation and virological breakthrough cumulative incidence rate of HBsAb and HBeAb in each observation point;The changes of relative immune parameters of the transfer factor in peripheral blood; | — |
Countries
China
Contacts
Public ContactWang Guiqiang
Outcome results
None listed