Key Project Foundation of Health Department of Anhui Province
Conditions
Interventions
Group A:Entecavir
Group B :Interleukin-2
Sponsors
The first affiliated hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Males or females with age from 18 to 65 years old; 2. Chronic HBV infected patients based on diagnostic criteria of 2010 China clinical practice guidelines of chronic hepatitis B (updated) with: (1) CHB patients have finished the treatment of PEG-IFN alpha-2a,and the percentage of Treg as well as CD4+CD25+T cells in PBMC do not increase after stimulated with IL-2; (2) positive HBsAg, positive HBeAg and serum HBV DNA level >=2*10^4 IU/ml; (3) ALT level >= 2-10 ULN; or ALT level >=1-2 ULN and histological proved hepatic inflammation or fibrosis >= Grade 2; 3. compensated liver disease with hematological indicators below: (1) WBC >=3.5*10^9/L; (2) neutrophil >=1.5*10^9/L; (3) PLT >=60*10^9/L; (4) Hb >=100g/L; (5) TBil =LLN; (7) BUN <=ULN; (8) Cr <=ULN; (9) PT prolonged <=3 sec, APTT in normal range; 4. TSH in normal range; 5. AFP <=ULN; 6. subjects (female or female partner of male patient) in child-bearing period could take effective contraception; 7. To be able to understand and sign the informed consent; 8. good medical compliance.
Exclusion criteria
Exclusion criteria: 1. positive anti-HCV, positive anti-HDV IgM or positive anti-HIV; 2. ANA titer >1:160; 3. decompensated liver diseases (rupture of esophageal and gastric varices, hepatic encephalopathy, etc.); 4. existing disease or history as bellows: (1) cardiac vascular system: unstable or obvious cardiacvascular diseases; (2) respiratory system: bronchiectasis, bronchial Asthma, COPD, respiratory failure, etc.; (3) endocrinic and metabolic disease: uncontrolled thyropathy and DM, etc.; (4) others: autoimmune disease, active tuberculosis, malignant diseases, history of neurological and mental diseases, acute or chronic pancreatitis, etc.; 5. anti-virus treatment or immunomodulator taken within 6 months before inclusion; 6. allergic constitution or might allergic to drugs involved in this study; 7. pregnant subject or in lactation, female subject or female partner plan to be pregnant; 8. alcohol abuse (male >40g/day, female >20g/day, last over 5 years) and drug dependence; 9. history of organ transplantation (except corneal transplantation and hair implantation); 10. subject involved in any other clinical trial in recent 3 months; 11. any factor not appropriate for subject to be involved into or to finish this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum HBsAg quantitation;serum HBeAg quantitation, seroclearance rate and seroconversion rate;HBV DNA quantitation;liver function;phenotype and function change of immunocyte;renal function;phenotype and function change of immunocyte; | — |
Countries
China
Contacts
Public ContactLi Jiabin
University of Science and Technology of China
Outcome results
None listed