Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B (EPCP)
Hepatitis B, Chronic
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic
Eligibility Criteria
Inclusion Criteria: Age 18 to 60 years, both sexes (both 18 and 60 years) HBsAg positive for more than 6 months; NAs treated patients on continuous NA therapy for more than 6 months with HBsAg ≥ 1500 IU/ml and HBV-DNA < 500 IU/ml at enrolment; Primary treated patients with surface antigen >1500 IU, unlimited E antigen and unlimited HBV DNA at enrolment, meeting the treatment indications of the 2019 edition of the guidelines for the prevention and treatment of chronic hepatitis B. negative urine or serum pregnancy test within 24 hours prior to the first dose (for women of childbearing age) Exclusion Criteria: Combined active hepatitis A, C, D, E and/or HIV infection; Patients who are on future and intend to continue to use tibivudine methaemoglobin greater than 100ng/ml at screening; or methaemoglobin that has not remained stable for 3 months prior to the trial and/or liver imaging suggestive of liver tumours; decompensated liver disease (Child-Pugh score ≥ 7), meaning that patients will be excluded if one of the following is met: prolonged prothrombin time ≥ 3 seconds, serum bilirubin > 34umol/L, history of hepatic encephalopathy, history of oesophageal variceal bleeding, ascites; pregnant or lactating women or patients with planned pregnancy during the study period and unwilling to use contraception Neutrophil count < 1.5 x 10^9/L or platelet count < 90 x 10^9/L and creatinine > 1.5 ULN History of severe psychiatric illness, especially depression. Major psychosis defined as major depressive disorder or psychosis, suicide attempts, hospitalisation for psychosis or incapacity for a period of time due to psychosis; history of immune-mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies Patients with severe combined diseases of the heart, lungs, kidneys, brain, blood and other vital organs, combined with other malignancies History of severe epilepsy or current treatment with anti-epileptic drugs. Unstable control of diabetes mellitus, hypertension, thyroid disease, etc. Patients with a history of severe retinopathy or as indicated by other evidence of retinopathy; History of any organ transplantation and existing functional grafts (except corneal or hair transplants); Patients who are allergic to interferon and its drug components and who, in the judgment of the investigator, are unsuitable for interferon application Patients who, in the opinion of the investigator, are not suitable for participation in this study.
Sites / Locations
- The First Affiliated Hospital of Anhui Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Continuous Combination Therapy Cohort
Pulsed Combination Therapy Cohort
Patients with primary CHB with HBsAg ≥ 1500 IU/ml and HBV-DNA < 500 IU/ml and patients with CHB after treatment with NAs will be enrolled. After fully informed consent, pegylated interferon alpha-2b 180µg will be administered by subcutaneous injection once a week for up to 96 weeks.
Patients with primary CHB with HBsAg ≥ 1500 IU/ml and HBV-DNA < 500 IU/ml and patients with CHB after treatment with NAs will be enrolled. After fully informed consent, pegylated interferon alpha-2b 180µg will be administered by subcutaneous injection once weekly for 8 weeks of treatment and discontinued for 4 weeks up to 96 weeks.