Chronic Hepatitis B
Conditions
Interventions
CHB combined with MAFLD:None
CHB without MAFLD:None
Sponsors
The Sixth People's Hospital of Shenyang
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who can understand the content, requirements, and restrictions of the protocol, fully comprehend the possible adverse reactions during the study, are willing to complete the follow-up visits as required, and voluntarily sign the Informed Consent Form (ICF) prior to any study procedures. 2. Aged between 18 and 65 years old (inclusive) at the time of signing the ICF, regardless of gender. 3. Positive for Hepatitis B surface antigen (HBsAg) for at least 6 months or other evidence indicating chronic hepatitis B, and HBsAg = 1000 IU/mL at screening. 4. Meets the diagnostic criteria for Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) according to the Guidelines for the Prevention and Treatment of Metabolic Associated (Non-Alcoholic) Fatty Liver Disease (2024 Edition). 5. Negative pregnancy test result at screening (for women of childbearing potential), and subjects (both male and female) agree to use effective contraceptive measures during the study period.
Exclusion criteria
Exclusion criteria: 1. Received standard treatment with interferon-based products within six months prior to screening. 2. Pregnant or lactating women, or individuals planning pregnancy during the study period. 3. Co-infection with chronic infectious diseases such as hepatitis A, C, D, E, or HIV. 4. Liver imaging at screening suggests the presence of a liver tumor. 5. Patients diagnosed with hepatitis B-related cirrhosis. 6. Neutrophil count 1.5 times the upper limit of normal. 7. Personal or family history (in parents, siblings, etc.) of severe psychiatric disorders, especially depression. 8. History of immune-mediated diseases (inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoantibodies. 9. Patients with severe diseases of vital organs (heart, lung, kidney, brain, blood, etc.), or with other malignant tumors. 10. History of severe epilepsy or current use of anti-epileptic drugs; poorly controlled diabetes, hypertension, thyroid disease, etc.; history of severe retinopathy or evidence of retinopathy. 11. History of any organ transplantation or presence of a functional graft (except for corneal or hair transplantation). 12. Known or suspected allergy to interferon or its excipients. 13. Participation in other interventional clinical trials within 3 months prior to screening, or planning to participate in other clinical trials during the study period. 14. Any other condition deemed by the investigator as inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg clearance rate at week 48; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in liver stiffness measurement (LSM) from baseline at 24 weeks after treatment cessation;HBsAg clearance rates at different treatment time points;Liver function at different treatment time points;Adverse events; | — |
Countries
China
Contacts
Public ContactFang Yang
The Sixth People's Hospital of Shenyang
Outcome results
None listed