Chronic hepatitis B
Conditions
Interventions
NAs combined with PegIFNa2b treatment group:None
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily enroll in the study with the ability to understand and sign the informed consent form; 2.Aged 18–65 years (inclusive) at the time of signing informed consent, regardless of gender; 3.HBsAg-positive at screening, with a documented history of HBsAg positivity =6 months or other evidence indicating CHB; 4.HBsAg <=1500 IU/mL and HBeAg-negative at screening; 5.No prior use of interferon or other immunomodulators within 6 months before treatment initiation; 6.Non-pregnant status (for women of childbearing potential) confirmed by the participant, with agreement to use effective contraception during the study period.
Exclusion criteria
Exclusion criteria: 1.Concurrent autoimmune liver disease, alcoholic hepatitis, drug-induced hepatitis, other viral hepatitis, moderate-to-severe steatohepatitis, decompensated liver disease, or hepatocellular carcinoma 2.History of significant organ diseases, including severe cardiac disorders, uncontrolled diabetes mellitus, hypertension, thyroid disorders, retinopathy, psychiatric disorders, autoimmune diseases, or epilepsy 3.Autoimmune diseases such as psoriasis or systemic lupus erythematosus 4.Diagnosed or suspected hepatocellular carcinoma or other malignancies 5.Active alcohol or substance abuse without sustained abstinence 6.Women who are breastfeeding or planning pregnancy within the next 2 years 7.History of organ transplantation or planned organ transplantation 8.Current use of immunosuppressive therapy 9.Serum ALT >10ULN or total bilirubin >2ULN (after discontinuation of hepatoprotective drugs for at least 2 weeks) 10.Neutrophil count <1.5×10^9/L and/or platelet count <50×10^9/L 11.Hypersensitivity to study drugs including PegIFNa or NAs.or any component 12.Presence of any contraindication listed in the prescribing information of study drugs 13.Active coinfection with hepatitis A, C, D, E, or HIV 14.Any other condition deemed ineligible for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA;HBV markers(including HBsAg,HBsAb,HBeAg,HBeAb,HBcAb);Precise quantification of HBsAg;Abdominal ultrasound indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in therapeutic drugs;Adverse reaction;AFP; | — |
Countries
China
Contacts
Public ContactEnqiang Chen
West China Hospital, Sichuan University
Outcome results
None listed