Chronic Hepatitis B
Conditions
Interventions
Oral Traditional Chinese Medicine (TCM) Combined with Peg-IFN-a-2b Group:Administer oral traditional Chinese medicine (TCM) in combination with pegylated interferon alpha-2b.
Peg-IFN-a-2b Group:Administer pegylated interferon alpha-2b therapy.
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age greater than 18 years, regardless of gender; 2. Patients diagnosed with chronic hepatitis B according to the Chinese "Guidelines for the Prevention and Treatment of Chronic Hepatitis B" (2022 edition); 3. Hepatitis B surface antigen positive, withHepatitis B surface antigen quantification < 1500 IU/mL; Hepatitis B e antigen negative, with serum Hepatitis B Virus DNA quantification < 2000 IU/mL; 4. Based on real-world clinical practice needs, patients who are treatment-naïve to pegylated interferon alpha-2b or are restarting pegylated interferon alpha-2b treatment; 5. No contraindications to interferon therapy; 6. Good compliance and voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: 1)Individuals allergic to interferon 2)Patients with clinical evidence of liver cirrhosis 3)Patients coinfected with Hepatitis A Virus, Hepatitis C Virus, Hepatitis D Virus, Hepatitis E Virus, or Human Immunodeficiency Virus 4)Patients with other liver diseases (e.g., drug-induced, alcoholic, autoimmune, or genetic metabolic liver diseases 5)Patients with severe diseases of major organs such as the heart, lungs, kidneys, or brain, or with retinal lesions 6)Patients with autoimmune diseases such as diabetes or thyroid disorders 7)Patients diagnosed with or suspected of having hepatocellular carcinoma or other malignant tumors 8)Patients who have undergone organ transplantation or are preparing for organ transplantation 9)Patients with peripheral blood white blood cell count 40 g/day for men, >20 g/day for women) or drug addiction 13)Patients with a history of mental or psychological disorders 14)Other conditions deemed by the investigator as unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatitis B surface antigen clearance rate at end of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hepatitis B surface antigen seroconversion rate at end of treatment;Hepatitis B surface antigen levels and magnitude of decline from baseline;Magnitude of Hepatitis B Virus DNA decline from baseline and proportion of patients with levels below the lower limit of detection at end of treatment;Hepatitis B surface antigen clearance rate at end of follow-up; Hepatitis B surface antigen seroconversion rate and sustained response rate of Hepatitis B surface antigen clearance at end of follow-up; | — |
Countries
China
Contacts
Public ContactMin Dai
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed