Chronic type B hepatitis with HBeAg(+)
Conditions
Interventions
Control group:Placebo
Vaccine group:Injection vaccine (YIC)
Sponsors
Institute of Biological Products of Beijing and Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 56 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 56, male or female; 2. Patients with HBsAg(+) longer than 6 month; 3. Patients with HBeAg(+), HBeAb (-), HBV- DNA PCR >=105u/ml; 4. Patients did not receive any antivirual therapy; 5. The ALT is not normal, greater than or equal to 2 times of the normal upper limited value and lower than 10 times of the normal upper limited value. The ALT of the patient was abnormal 6 months before enter the trial, and the abnormality existed more than 1 month; 6. The urine or blood pregnancy test of reproductive aged women are negative. All reproductive period patients must take contraception from the start of the screening period to 3 months after the trial.
Exclusion criteria
Exclusion criteria: 1. pregnant or lactated women; 2. mother-baby transmitter or suspect mother-baby transmitter; 3. patients suffered the severe chronic hepatitis in 2 years; 4. patients received antiviral or powerful immunomodulator systematically; 5. patients have one of other following virus infection: anti-HAV, IgM, anti-HDV,anti-HEV, anti-HIV; 6. patients had vaccine allergy history or had autoimmune disease history; 7. patients had taken the hepatotoxicity drugs 6 month before including for a long time; 8. liver cirrhosis suspected or compensation stage of liver cirrhosis; 9. primary hepatic carcinoma suspected or AFP>100ug/ml; 10. patients with liver disease caused by other fators: chronic alcoholic hepatitis, drug induced hepatitis, autoimmune hepatitis, Wilson disease and hemachromatosis; 11. patients have other severe disease except hepatitis: uncontrolled heart, lung, kidney, digestion, nerve, mental disorder, metabolic disease, malignant tumor,and so on; 12. patients with serum creatinine more than 1.5 times than normal upper limit value; 13. blood platelets count <80*10^9/L; 14. white cell count <3*10^9/L; 15. hemoglobin <11.5g/dL (female), <12.5g/dL (male); 16. serum total bilirubin more than 2 times of the mormal upper limit value; 17. had drug addiction (including alchol) evidence 1 year before entering the trial; 18. patients took part in clinical trial of other drugs 3 months before entering the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virological response; | — |
Secondary
| Measure | Time frame |
|---|---|
| liver function; | — |
Countries
China
Contacts
Public ContactDaozhen Xu
Outcome results
None listed