Pegylated Interferon Alfa-2b in Reducing Relapse Rates After Nucleos(t)ide Analogue Withdrawal in HBeAg-negative CHB Patients with Low Level HBsAg

Korábbi kezelés

• Received immunomodulators (including interferon, etc.) within 1 year before screening;

Más betegség

• Patients with hepatitis B cirrhosis in the compensatory and decompensated stage: patients with a clear history of cirrhosis (imaging or histological evidence) or Child-Pugh score ≥5 before NUC treatment, or complications of cirrhosis in the decompensated stage such as ascites, hepatic encephalopathy, esophageal variceal hemorrhage, etc.;
• Patients who are allergic to alpha interferon and its drug ingredients, and the researchers judge that alpha interferon is not suitable for patients;
• Combined with HAV, HCV, HDV, HEV, HIV infection, alcoholic liver disease, genetic metabolic liver disease, drug liver disease, non-alcoholic fatty liver disease and other chronic liver diseases;
• Combined with autoimmune diseases, including autoimmune liver disease, psoriasis, etc.
• Patients with primary liver cancer or screening with AFP greater than 100 ng/ml and imaging findings indicating the possibility of malignant liver occupation; Or AFP greater than 100 ng/ml for 3 months;
• Patients with other malignant tumors (excluding cured patients);
• Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs;
• Patients with severe neurological and psychiatric disorders (such as epilepsy, depression, mania, seizures, schizophrenia, etc.);
• Control unstable diabetes, hypertension, thyroid disease, etc.;

Laborértékek

• Neutrophil count \< 1.5 x 109 cells /L or platelet count \< 90 x 109 cells /L;
• Creatinine is 1.5 times higher than the upper limit of normal;

Egyéb

• HBsAb positive during screening;
• Pregnant and lactating women or patients who had pregnancy plans during the study period and did not want to use contraception;
• Participate in other clinical investigators;
• Patients who were not considered suitable for participation in this study by the investigators.

• Aged between 18 and 65 (inclusive), regardless of gender;
• Fibroscan ≤ 7.4kpa;
• HBeAg-negative CHB patients: HBsAg positive, HBeAg negative, HBsAb negative and HBeAb positive before receiving NUC treatment and during screening in this study;
• HBeAg-negative chronic hepatitis B patients without liver cirrhosis who have been viral-negative for more than 3 years after receiving NUC treatment, and they meet the 2017 EASL guideline discontinuation standard (HBV DNA is lower than the lower limit of detection, that is, \<20 IU/ml);
• HBsAg≤1000 IU/ml;
• Have the intention to stop taking the drug, and sign a written informed consent.