A Prospective Study of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis B

Exclusion Criteria

• •Pregnant or lactating females
• •Interferon treatment history, or using nucleos(t)ide analogues for chronic hepatitis B treatment within the previous 6 months, or any evidence of nucleosi(t)ide analogues resistance .
• •Receiving strong immunomodulatory agents (e.g., steroids, thymosin) for more than two weeks 6 months prior to screening.
• •Receiving hepatotoxicity agents (e.g., aczone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than two weeks 6 months prior to screening.
• •Co-infected with active hepatitis A, hepatitis C, hepatitis D, and/or human immunodeficiency virus (HIV).
• •History or evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., autoimmune hepatitis, alcoholic liver disease, toxin exposures.
• •Suffering from any other acute or chronic infectious disease.
• •Mental disorder or physical disability, or family history of neurological and psychiatric disorders.
• •Neutrophil count \<1500 cells/mm3, or platelet count \<90000 cells/mm3 at screening.
• •Child-Pugh≥B, or other evidence of liver decompensation (e.g. serum albumin\<35g/L , prothrombin time\>3 seconds prolonged, serum bilirubin\>2ULN, prothrombin activity \<60%, history of liver decompensation).
• •Serum creatinine level \>ULN in screening period.
• •Serum creatine kinase level \>2ULN except for physiological factors (e.g., exercise).
• •AFP\>100ng/L. If 50ng/L\<AFP\<100ng/L at screening, retest 2 weeks later, and if AFP \<50ng/L can enrolled, vs, excluded.
• •Hepatocarcinoma or suffering from any other malignant tumor.
• •Autoimmune disease(e.g., psoriasis, systemic lupus erythematosus).
• •Moderate or severe hypertension, or mild hypertension without well controlled.
• •With not well- controlled endocrine disease (e.g., thyroid dysfunction, diabetes mellitus).
• •Drug abusing, or alcoholism.
• •HBeAb positive or HBsAb positive at screening.
• •Allergic to interferon, or GM-CSF, or any fragment of the study drug.
• •Other conditions which in the opinion of the investigator precluding enrollment into the study(e.g., low compliance).