Chronic (viral) hepatitis B
Conditions
Interventions
1:TDF
2:PEG-IFN-a2b + TDF + GM-CSF+ HBV Vaccine
Sponsors
The First Affiliated Hospital,College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. signed the informed consent form; 2. HBsAg (+); 3. aged 18-65 years old male or female; 4. HBsAg titers less than or equal to 1500 IU / mL in the queue Inscript Study; 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. Including female and male patients female companion
Exclusion criteria
Exclusion criteria: 1. patients with a allergy history of interferon, nucleoside (acid)antiviral drugs, colony stimulating factor or hepatitis B vaccine; 2. patients with HAV, HCV, HDV, HEV, HIV co-infection; 3. patients with cirrhosis or a Child-Pugh score of more than 7 points; 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 a history of alcoholism or drug abuse within one year before screening into the trail; 7. neutrophil count <1.5 × 10^9/L or hemoglobin <100 g/L or platelet count <80 x 10^9/L; 8. patients with serum creatinine higher than normal limit during screening; 9. patient with a histroy of severe heart, brain, kidney, retina, muscle or other vital organs disease; 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. Chronic diseases that require long-term treatment, such as hypertension, diabetes, chronic obstructive pulmonary disease, etc.; 13. patients with malignancy; 14. B-ultrasonography detected suspicious liver malignancies in the screening group, or alpha-fetoprotein was greater than 100 ng/mL; or alpha-fetoprotein could not be stable within 3 months before the test; 15. History of important organ transplants; 16. Researchers consider other diseases that are not suitable for the study.
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
The First Affiliated Hospital, College of Medicine, Zhejiang University.
Outcome results
None listed