Chronic Hepatitis B
Conditions
Interventions
vaccine group:antigen-antibody immunocomplex therapeutic vaccine
placebo control group:alum
Sponsors
BEIJING DITAN HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patient with signed informed consent form; 2. Patients with chronic hepatitis B aged 18 to 65 years; 3. Patients with > 6 months HBsAg positive prior to study; 4. HBeAg positive, HBeAb negative, and HBV DNA 1*10**5 copies/ml; 5. Patient without anti-viral therapy prior to recruitment; 6. Patients with ALT abnormal (2-fold higher but 10-fold less than cutoff at baseline.)7.Preganency testing negative for female patients.
Exclusion criteria
Exclusion criteria: 1. Co-infection with hepatitis A, C, D and E virus, or HIV; 2. Taking antiviral, hepatotoxic or immunosuppressive drugs or products within the preceding 6 months; 3. Other causes of liver disease; 4. Serious medical or psychiatric illness; 5. Hepatic cirrhosis or AFP>100 ng/ml; 6. Abnormal serum creatinine, thrombocyte count, 7. Hematoglobin or serum total bilirubin abnormal; 8. And pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBeAg seroconversion; | — |
Countries
China
Contacts
Public ContactDAO-ZHEN XU
Outcome results
None listed