Chronic Hepatitis B
Conditions
Interventions
Experimental group:The experimental group will receive Qing'ao Granules (granule dosage form, 1 sachet each time, 3 times a day, taken after meals) for 24 weeks, PEG IFN a-2b (180 µg or 135 µg/week) v
Control group:The control group will receive PEG IFN a-2b (180 µg or 135 µg/week) via subcutaneous injection, and NAs (ETV/TDF/TAF/TMF) via oral administration for 48 weeks.
Sponsors
Hospital of Traditional Medicine LS.SC
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary enrollment, able to understand and voluntarily sign the informed consent form. 2.Aged 18 to 60 years (inclusive) at screening, regardless of gender. 3.History of HBsAg positivity for at least 6 months or other evidence indicating chronic hepatitis B (HBeAg positive/negative). 4.HBsAg <= 5000 IU/mL, HBeAg negative, and HBV DNA negative at screening. 5.Negative pregnancy test within 24 hours before the first medication (for women of childbearing potential); and subjects should adopt effective contraceptive measures during the study. 6.No contraindications to interferon or nucleos(t)ide analogue therapy, and willing to receive combined treatment with PEG-IFN and NAs.
Exclusion criteria
Exclusion criteria: 1.Individuals with contraindications to the traditional Chinese medicine components of Qing'ao Granules or allergies to its ingredients. 2.Those with evidence of acute severe liver injury: such as ALT > 10 times the upper limit of normal (ULN), or significantly elevated ALT accompanied by significantly elevated bilirubin. 3.Decompensated cirrhosis. 4.Individuals with peripheral blood white blood cell count and/or platelet count below the lower limit of normal, and those with neutrophil count < 1.5×10^9/L. 5.Individuals with severe organic diseases in vital organs (e.g., cardiovascular, pulmonary, renal, cerebral diseases) or fundus lesions. 6.Individuals with comorbid autoimmune diseases, mental disorders, diabetes, or thyroid dysfunction (hyperthyroidism or hypothyroidism). 7.Individuals with confirmed or suspected liver cancer or other malignant tumors. 8.Individuals post-organ transplantation or scheduled for organ transplantation. 9.Individuals currently using immunosuppressants. 10.Pregnant individuals or those planning to become pregnant within 2 years. 11.Individuals with alcoholism or drug addiction. 12.Individuals coinfected with hepatitis C virus or human immunodeficiency virus. 13.Other conditions deemed unsuitable for study inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of HBsAg seronegativity;Proportion of HBsAg seroconversion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of HBsAg seronegativity;Proportion of HBsAg seroconversion;The magnitude of HBsAg level decline from baseline;Proportion of HBV DNA below the lower limit of detection;Safety assessment; | — |
Countries
China
Contacts
Public ContactDing Xiangdi
Hospital of Traditional Medicine LS.SC
Outcome results
None listed