Chronic Hepatitis B (CHB) with Comorbid Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)
Conditions
Interventions
Peginterferon Group (Peginterferon alfa-2b Injection,Nucleos(t)ide Analogues):None
Control Group [Nucleos(t)ide Analogues]:None
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Subjects must demonstrate comprehension of the study protocol (including requirements, constraints, and potential adverse reactions), voluntarily sign the informed consent form (ICF) prior to study initiation, and commit to complete all scheduled follow-ups. 2.Age >= 18 and = 6 months (or other evidence confirming CHB diagnosis), with ongoing nucleos(t)ide analogue (NAs) therapy for >= 6 months prior to screening and undetectable HBV DNA at screening. 4.Ultrasound-confirmed hepatic steatosis at screening, with Controlled Attenuation Parameter (CAP) >= 248 dB/m or MRI-PDFF >= 8%. 5.Meet the diagnostic criteria for MAFLD per the *Chinese Guidelines for the Prevention and Treatment of Metabolic-Associated (Non-Alcoholic) Fatty Liver Disease (2024 Edition)*.
Exclusion criteria
Exclusion criteria: 1.Received standard interferon therapy within 6 months prior to screening (defined as >3 consecutive months of interferon use). 2.Pregnancy, lactation, or plans for pregnancy during the study period. 3.Active co-infections with chronic hepatitis A/C/D/E, or HIV. 4.Current use of medications known to cause steatosis/steatohepatitis (e.g., tamoxifen, methotrexate, corticosteroids >= 5 mg/day prednisone equivalent for >3 months). 5.Use of weight-loss medications (e.g., GLP-1 agonists), history of bariatric surgery, or planned bariatric surgery during the study. 6.Other concurrent liver diseases, including but not limited to: Drug-induced liver injury (DILI) Alcohol-associated liver disease (ALD) Autoimmune hepatitis (AIH) Hemochromatosis Wilson disease Suspected or confirmed hepatocellular carcinoma (HCC); 7.Excessive alcohol consumption (>20 g/day for women, >30 g/day for men) for >= 3 consecutive months within 1 year prior to screening, or uncontrolled alcohol use. 8.Uncontrolled metabolic disorders, including: Poorly controlled diabetes (HbA1c >8.5%) Uncontrolled hypertension (BP >160/100 mmHg on medication) Clinically significant thyroid dysfunction; 9.Severe psychiatric disorders (particularly major depression) or related history requiring hospitalization. 10.Severe hepatic impairment (Child-Pugh B/C) or decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy). 11.Severe ophthalmologic diseases (e.g., retinopathy, optic neuritis). 12.Severe organ dysfunction (e.g., CKD stage 4-5, NYHA class III-IV heart failure). 13.Known hypersensitivity to interferon or excipients. 14.Participation in other interventional trials within 3 months prior to screening or planned during this study. 15.Any condition deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg Clearance Rate;Liver Stiffness Measurement (LSM); | — |
Secondary
| Measure | Time frame |
|---|---|
| Controlled Attenuation Parameter (CAP);Blood Lipids;BMI;weight;Fasting Blood Glucose (FBG);ALT;Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF);AST;Insulin;HBeAg Seroconversion Rate;Liver Enzymes;HBeAg Seroclearance Rate; | — |
Countries
China
Contacts
Public ContactHuiying RAO
Peking University People's Hospital
Outcome results
None listed