A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B

Sponsor
Beijing 302 Hospital
Study ID
NCT06926647
Status
Not Yet Recruiting

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Conditions

  • Chronic Hepatitis b
  • HBV

Eligibility Criteria

Sex
ALL
Age
1 Year - 13 Years
Healthy Volunteers
Not accepted

Interventions

  • Nucleos(t)ide Analogues — DRUG
    Administer NAs \[LAM, ETV, TDF, TAF (TAF preferred for those aged 6 years and older)\] continuously for 48 weeks based on age.
  • Interferon alfa — DRUG
    IFNα monotherapy for 48 weeks (select conventional IFNα for ages ≥1 and \<3 years, select PEG-IFNα-2b for ages ≥3 years)
  • NAs combined with IFNα — DRUG
    Receive NAs combined with IFNα treatment for 48 weeks.
  • comparative observation — OTHER
    Blank control observation for 48 weeks.
  • drug withdrawal observation — OTHER
    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)

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Apr 2025
Primary completion
Dec 15, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: Initial Treatment Cohort 1
  • Arm: Previously Treated Cohort 1

Primary Outcome Measure

HBsAg seroconversion rate [ Time Frame: Week 48,96 ]

Central Contacts

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