Chronic hepatitis B
Conditions
Interventions
Peg-IFN-a group:None
Patients received no treatment group:None
Sponsors
The Second Affiliated Hospital of Xi’an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years, with no restriction on gender; 2. Diagnosed with chronic hepatitis B virus (HBV) infection, defined as serum HBsAg positivity for more than 6 months; 3. Serum HBeAg negative, with anti-HBe negative or positive, and HBV DNA =3 consecutive normal results within 1 year, with at least 3-month intervals); 5. No previous antiviral therapy, including nucleos(t)ide analogues (NAs), interferon-a (IFN-a), or pegylated interferon-a (Peg-IFN-a); 6. Liver stiffness measurement (LSM) < 12.0 kPa; 7.No radiological evidence of liver cirrhosis (LC) on upper abdominal computed tomography (CT); 8. No contraindications to Peg-IFN-a treatment; 9.Negative urine or serum pregnancy test within 24 hours before the first dose (for women of childbearing potential); 10.Willingness to participate in the study and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with compensated or decompensated liver cirrhosis secondary to hepatitis B; 2. Coinfection with human immunodeficiency virus (HIV) or other hepatitis viruses, including hepatitis A, C, D, or E virus (HAV, HCV, HDV, HEV); 3. History or evidence of other chronic liver diseases unrelated to viral hepatitis, such as hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure, or thalassemia; 4. Presence of hepatocellular carcinoma (HCC), defined as a-fetoprotein (AFP) > 100 ng/mL at screening with imaging findings suggestive of malignancy, or persistent AFP > 100 ng/mL for more than 3 months; 5. White blood cell count 1.5 × upper limit of normal (ULN); 8. Coexisting thyroid disease, psoriasis, or neurogenic deafness; 9.Severe retinopathy or other clinically significant ophthalmic disorders (e.g., hypertensive or diabetic retinopathy, macular degeneration, high myopia, fundus hemorrhage); 10. Severe neurological or psychiatric disorders (e.g., depression, mania, schizophrenia); 11. Uncontrolled epilepsy, diabetes mellitus, or hypertension; 12.Positive antinuclear antibody (ANA) titer > 1:100 or a history of autoimmune diseases (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis); 13. Presence of other malignant tumors, except those considered cured; 14. Hemoglobin < 110 g/L for females or < 120 g/L for males; 15. Pregnant or lactating women, or women planning pregnancy or unwilling to use effective contraception during the study period; 16. History of alcohol abuse or drug addiction; 17. Participation in another clinical study simultaneously; 18. Deemed unsuitable for participation by the investigator or attending physician; 19. Unwilling or unable to provide written informed consent or comply with study requirements; 20. Known hypersensitivity to interferon-a (IFN-a) or any of its components, or judged unsuitable for IFN-a treatment; 21. Any other contraindication listed in the product labeling of the investigational drug not covered by the above criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative HBV Serological Markers (HBV Five Items); Quantitative HBV DNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nucleic acid: pg RNA,cccDNA;Omics differences: immunogenomics, immunoproteomics, and immunoinformatics;Imaging indicators: Upper Abdominal CT, Ultrasonography, or MRI; | — |
Countries
China
Contacts
Public ContactWu Fengping
The Second Affiliated Hospital of Xi’an Jiaotong University
Outcome results
None listed