This is a multicenter, prospective, real-world study. The study plans to include a total of 2000 patients who meet the inclusion and exclusion criteria, consisting of 1600 treatment-naive patients and 400 treatment-experienced patients. The effectiveness and safety of different treatment strategies will be evaluated in children aged 1-12 years with treatment-naive and treatment-experienced chronic hepatitis B (CHB) and chronic HBV infection.
Study Type
OBSERVATIONAL
Enrollment
2,000
Administer NAs \[LAM, ETV, TDF, TAF (TAF preferred for those aged 6 years and older)\] continuously for 48 weeks based on age.
IFNα monotherapy for 48 weeks (select conventional IFNα for ages ≥1 and \<3 years, select PEG-IFNα-2b for ages ≥3 years)
Receive NAs combined with IFNα treatment for 48 weeks.
HBsAg seroconversion rate
Time frame: Week 48,96
HBV DNA negative conversion rate
Time frame: Week 48,96
HBeAg negative conversion rate
Time frame: Week 48,96
HBeAg seroconversion rate
Time frame: Week 48,96
HBsAg seroconversion rate
Time frame: Week 48,96
ALT normalization rate
Time frame: Week 48,96
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Blank control observation for 48 weeks.
This group is the drug withdrawal observation group, which will strictly monitor virological indicators and biochemical results, and will reinitiate antiviral treatment if necessary based on antiviral treatment standards and the willingness of the child (or family members)
Ankang Central Hospital
Ankang, China
Anyang Fifth People's Hospital
Anyang, China
Beihai People's Hospital
Beihai, China
301 Hospital
Beijing, China
Binzhou Medical University Affiliated Hospital
Binzhou, China
Changzhi Medical College Affiliated Peace Hospital
Changzhi, China
Changzhou Third People's Hospital
Changzhou, China
Chengdu Public Health Clinical Medical Center
Chengdu, China
West China Second Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
...and 75 more locations