chronic (viral) hepatitis B
Conditions
Interventions
group A:PEG-IFN alfa-2b+GM-CSF+HBV vaccine
group B:PegIFN-alfa-2b+GM-CSF
group C:PegIFN-alfa-2b
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Naive patients inclusion criteria: 1. signed the informed consent form; 2. HBsAg (+), and the duration of HBsAg (+) for more than six months, and HBsAg titers less than or equal to 50000 IU/mL; 3. HBeAg (+); 4. aged 18-65 years oldmale or female; 5. ALT >=2 times the upper limit of normal(ULN) or liver biopsy showing above G2 inflammation or S2 fibrosis stage, and HBVDNA>=105 copies/mL (or HBVDNA >=2*10^4 IU/mL); 6. pregnancy test should be negative in childbearing age female patients before the treatment, and can take effective contraceptive measures during treatment and within six months after the end of treatment. (including female and male patients' female companion).
Exclusion criteria
Exclusion criteria: Naive patients exclusion criteria: 1. patients with previous nucleoside (acid), interferon treatment history of anti-hepatitis B virus before the enrolled screening of the trials 6 months; 2. ALT>=10 times the upper limit of normal(ULN) or total bilirubin>=2 times the upper limit of normal(ULN); 3. patients whose known interferon, colony stimulating factor, hepatitis B vaccine allergy history; 4. patients with HAV, HCV, HDV, HEV, HIV-infection; 5. patients with cirrhosis diagnosed by imaging or histology or Child-Pugh score 7 points and above; 6. patients with medical history or evidence of other liver disease (such as autoimmune liver disease, alcoholic liver disease, nonalcoholic fatty liver disease, drug-induced hepatitis, Wilson degeneration, etc.); 7. pregnant or lactating women; 8. patients with history of alcoholism or drug addiction before the enrolled screening of the trials a year; 9. neutrophil count = 7 points; 13. patients with endocrine system or autoimmune disease history, such as thyroid disease, diabetes, systemic lupus erythematosus, sarcoidosis, autoimmune thrombocytopenic purpura, etc.; 14. patients with chronic diseases needing long-term treatment, such as hypertension, diabetes, chronic obstructive pulmonary disease, etc.; 15. patients with malignancy; 16. patients with trial into the group screened B-suspicious hepatic malignancies, or alpha-fetoprotein greater than 100ng/mL, or alpha-fetoprotein in the three months before the test can not be stable; 17. patients with important history of organ transplantation; 18. patients with diseases which researchers believe that does not fit into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBeAg seroconversion rate at Week 72; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBeAg seroconversion rate at week 48;HBsAg seroconversion at week 48 and week 72;HBsAg loss rate at week 48 and week 72;HBeAg loss rate at week 48 and week 72;cumulative rate of undetectable HBV DNA level at week 48 and week 72;cumulative rate of ALT normalization at week 48 and week 72; | — |
Countries
China
Contacts
Public ContactJiming ZHANG
Outcome results
None listed