Chronic (viral) hepatitis B
Conditions
Interventions
1-1:INF-a2b
1-2:INF-a2b+ADV
1-3:INF-a2b+ADV+GM-CSF
1-4:INF-a2b+ADV+GM-CSF+HBV Vaccine
2-1:Primary nucleoside acid anti-virus therapy
2-2:Primary nucleoside acid anti-virus therapy + INF-a2b
2-3:NA+INF-a2b+GM-CSF
2-4:Primary nucleoside acid anti-virus therapy + INF-a2b+GM-CSF
Sponsors
Zhejiang 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 1500 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, 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, the treating patients inclusion criteria: 1. signed the informed consent form; 2. HBsAg (+), and HBsAg titers less than or equal to 1000IU/mL; 3. aged 18 to 65 years old, male or female; 4. HBeAg-positive chronic hepatitis B patients with antiviral therapy by nucleoside analogues (lamivudine, adefovir dipivoxil, entecavir single-agent or combination therapy) has reached HBeAg seroconversion, HBV DNA <1000copies/mL (or 200IU/mL), ALT/AST normalization and consolidation therapy for 1 year; 5. 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.
Exclusion criteria
Exclusion criteria: Naive patients exclusion criteria: 1. patients whose known interferon, nucleoside (acid) class of antiviral drugs, colony stimulating factor, hepatitis B vaccine allergy history; 2. patients with previous nucleoside (acid), interferon treatment history of anti-hepatitis B virus; 3. patients with HAV, HCV, HDV, HEV, HIV-infection; 4. patients with cirrhosis or Child-Pugh score 7 points and above; 5. 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.); 6. pregnant or lactating women; 7. patients with history of alcoholism or drug addiction before the screening of the trials enrolled a yea; 8. neutrophil count =7 points; 12. patients with endocrine system or autoimmune disease history, such as thyroid disease, diabetes, systemic lupus erythematosus, sarcoidosis, autoimmune thrombocytopenic purpura, etc.; 13. patients with chronic diseases needing long-term treatment , such as hypertension, diabetes, chronic obstructive pulmonary disease, etc.; 14. patients with malignancy; 15. 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; 16. patients with important history of organ transplantation; 17. patients with diseases which researchers believe that does not fit into the study. The treating patients exclusion criteria: 1. patients whose known interferon, nucleoside (acid) class of antiviral drugs, colony stimulating factor, hepatitis B vaccine allergy history; 2. patients with HAV, HCV, HDV, HEV, HIV-infection; 3. patients with cirrhosis or Child-Pugh score 7 points and above; 4. 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.); 5. pregnant or lactating women; 6. patients with history of alcoholism or drug addiction before the screening of the trials enrolled a yea; 7. neutrophil count <1.5 × 109 / L or hemoglobin <100 g / L or platelet count <80 x 109 / L; 8. patients with serum creatinine above the upper limit of normal when trial enrolled screening; 9. patients with serious heart, brain, kidney, retina, muscle and other vital organs, tissue disease history; 10. patients with history of mental illness or a family history of mental illness, or Hamilton depression scale score = 7 points; 11. patients with endocrine system or autoimmune disease history, such as thyroid disease, diabetes, systemic lupus erythematosus, sarcoidosis, autoimmune thrombocytopenic purpura, etc.; 12. patients with chronic diseases needing long-term treatment , such as hypertension, diabetes, chronic obstructive pulmonary disease, etc.; 13. patients with malignancy; 14. patients with trial into the group screened B-suspicious hepatic malignancies, or alpha-fetoprotein greater than 100ng/mL, or al
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV-DNA;HBV M test;Liver pathology examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical examination;Liver function test; | — |
Countries
China
Contacts
Public ContactYida Yang
Outcome results
None listed