Chronic hepatitis B
Conditions
Interventions
Continuous combined therapy:NAs combined with interferon will be continued for 48 weeks with unlimited NAs drugs, given as pegylated interferon alpha-2b 180 µg administered once a week for 48 weeks. A
Pulse combined therapy:Continuous treatment of NAs combined with interferon for 48 weeks, with no restrictions on NAs medication and administration of pegylated interferon a- 2b 180 µ g once a week, t
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 to 60 years old, male or female (both 18 and 60 years old); 2) HBsAg positive for more than 6 months; 3) NAs treated patients with continuous treatment with NA for more than 6 months and HBsAg = 1500 IU/ml and HBV-DNA 1500 IU, unlimited E antigen and unlimited HBV DNA at enrollment, meeting the treatment indications of the 2019 edition of the guidelines for the prevention and treatment of chronic hepatitis B. 5) Negative urine or serum pregnancy test within 24 hours prior to the first dose (for women of childbearing age); 6) Willingness to accept treatment and sign an informed consent form;
Exclusion criteria
Exclusion criteria: 1) Combined active hepatitis A, C, D, E, and/or HIV infection; 2) Patients who are on future and intend to continue to use tibivudine 3) Methemoglobin greater than 100 ng/ml at screening; or methemoglobin that has not remained stable for 3 months prior to the trial and/or liver imaging suggestive of liver tumor; 4) 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 bleeding esophageal varices, ascites; 5) Pregnant or lactating women or patients with planned pregnancy during the study period and unwilling to use contraception 6) Neutrophil count 1.5 ULN 7) History of severe psychiatric disorders, especially depression. Major psychiatric disorder defined as major depressive disorder or psychosis, suicide attempt, hospitalization for psychiatric disorder, or loss of capacity for a period of time due to psychiatric disorder; 8) History of immune-mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies; 9) Patients with severe combined heart, lung, kidney, brain, blood and other important organ diseases, combined with other malignant tumors 10) 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; 11) History of any organ transplantation and existing functional grafts (except corneal or hair transplants) 12) Patients who are allergic to interferon and its drug components and who, in the judgment of the investigator, are not suitable for interferon application 13) Patients who, in the judgment of the investigator, are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg negative rate and HBsAb seroconversion rate at 96 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBeAg negative rate and HBeAg seroconversion rate at 96 weeks of treatment; | — |
Countries
China
Contacts
Public ContactJiabin Li
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed