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

Korábbi kezelés

• Antinuclear antibody (ANA) exceeds 1:100.
• Subjects with severe heart disease, especially those with unstable angina or poorly controlled heart disease within 6 months prior to screening.
• 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.
• 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.

Más betegség

• 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.
• 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).
• Severe retinopathy or any other severe diseases in the eyes.
• Subject who are allergic to interferon, tenofovir, or any excipients, or meet any of the contraindications described in the drug instructions.

Laborértékek

• 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.

Egyéb

• Women who are pregnant, breastfeeding or planning to pregnant during the study period.
• Moderate to severe steatohepatitis.

• Understand and sign the informed consent form voluntarily.
• Age between 18 and 65 years (including 18 and 65), no gender limit.
• HBsAg-positive for at least 6 months or other evidence supporting chronic infection with hepatitis B virus.
• HBsAg positive at screening.
• For NAs treated patients: Who should have continuously taken NAs for at least 9 months prior to screening, and are currently receiving the NAs. Simultaneously, the patients should have achieved the following criteria: HBsAg\<1500IU/mL, HBV DNA\<100IU/ml, HBeAg\<10s/co at screening.
• For treatment naive patients: HBV DNA≥1×10\^4IU/ml, and 2×ULN (upper limit of normal) ≤ALT≤10×ULN at screening.
• Pregnancy test of female of childbearing must be negative within 24 hours before the first medication, and the subjects (male and female) should take effective contraceptive measures during the whole study period.