Chronic HBV infection
Conditions
Interventions
Nucleos(t)ide Monotherapy Group:None
Interferon Monotherapy Group:None
Sponsors
Guangzhou Eighth People’s Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 or above (including 18), any gender; 2. History of HBsAg positivity for at least 6 months; 3. HBsAg <=1500 IU/ml, and HBeAg negative; 4. HBV DNA <2000 IU/ml; 5. No antiviral treatment (including nucleos(t)ide analogues or interferon) in the year prior to enrollment; 6. Good compliance and voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals allergic to interferon; 2. ALT greater than 2 times the upper limit of normal, total bilirubin greater than 1.5 times the upper limit of normal; 3. Evidence of decompensated liver cirrhosis (Child-Pugh score >= Class B); 4. Co-infection with hepatitis A, C, D, E, or other viral infections; 5. Co-existing liver diseases (such as drug-induced, alcoholic, autoimmune, or hereditary metabolic liver diseases); 6. Presence of severe major organ diseases such as cardiovascular, pulmonary, renal, encephalopathy, or fundus lesions; 7. Co-existing autoimmune diseases, psychiatric disorders, diabetes, or thyroid diseases; 8. Confirmed or suspected liver cancer and other malignancies; 9. Post-organ transplantation or preparing for organ transplantation; 10. Peripheral white blood cell count 40g, women >20g) or drug addiction; 12. Currently using immunosuppressants; 13. Pregnant, breastfeeding, or planning pregnancy during the study; 14. Other conditions deemed unsuitable for enrollment by the study physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg clearance rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation indicators (adverse events, physical examination, vital signs, clinical laboratory tests, imaging examinations, drug exposure, early withdrawal, etc.); | — |
Countries
China
Contacts
Public ContactLi Jianping
Guangzhou Eighth People’s Hospital, Guangzhou Medical University
Outcome results
None listed