A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B

Exclusion Criteria

• •Women who are pregnant, breastfeeding or planning to pregnant during the study period.
• •Subjects with neuropsychiatric diseases and/or neuropsychiatric family history, especially depression, anxiety, or mania schizophrenia.
• •Co-infected with Hepatitis A, Hepatitis C, Hepatitis D, Hepatitis E, or HIV.
• •Chronic hepatitis other than hepatitis B, e.g. alcoholic hepatitis, drugs-induced hepatitis, or autoimmune hepatitis, etc.
• •Moderate to severe steatohepatitis.
• •Evidence of acute severe hepatitis, e.g. ALT\>10×ULN, significantly increasing in ALT accompanied by elevated bilirubin, etc.
• •Evidence of liver decompensation, e.g. total bilirubin higher than 2×ULN, albumin lower than 35g/L, prothrombin time is 3 seconds longer than the upper limit of normal, prothrombin activity lower than 60%, or history of decompensated liver cirrhosis, etc.
• •Evidence of hepatocellular carcinoma, or AFP\>1×ULN.
• •Significant kidney diseases, including acute nephritis, chronic nephritis, renal insufficiency, nephrotic syndrome, etc. or serum creatinine higher than upper limit of normal.
• •Neutrophil count less than 1.5×10\^9/L, or platelet count less than 90×10\^9/L at screening.
• •Serum phosphorus lower than 0.8mmol/L.
• •Antinuclear antibody (ANA) exceeds 1:100.
• •Autoimmune disease, including psoriasis, systemic lupus erythematosus, etc.
• •Subjects with endocrine system disease, including thyroid, Diabetes mellitus, etc.
• •Poorly controlled hypertension (blood pressure ≥140/90 mmHg).
• •Subjects with severe heart disease, especially those with unstable angina or poorly controlled heart disease within 6 months prior to screening.
• •Severe retinopathy or any other severe diseases in the eyes.
• •Subject who had ever received organ transplants or are planning to receive organ transplant.
• •For NAs-treated patients: who have received standard treatment of interferon products within 6 months prior to screening .
• •For treatment naive patients: who have ever received standard treatment of interferon products, or who have ever received NAs within 6 months prior to screening.
• •Subject who are allergic to interferon, tenofovir, or any excipients, or meet any of the contraindications described in the drug instructions.
• •Subjects who participated in any other interventional trials within 3 months prior to screening, or with any other conditions which in the opinion of the investigator precluding enrollment from the study.