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This study was a multicenter, prospective randomized controlled clinical study. A total of 60 HBV-infected infants with ALT ≤5 times the upper limit of normal (ULN) and without pathological jaundice were enrolled and randomized 1:1 into two groups: the control group and the antiviral treatment group. HBV-infected infants in the treatment group were treated with LAM before the age of 1 year and then combined with regular interferon for 52 weeks if they were still positive for HBV DNA and/or HBsAg after reaching the age of 1 year. The control group was followed up synchronously. Follow-up was conducted every 3 months during the study period. The main efficacy evaluation indexes: HBsAg conversion (functional cure) rate, HBeAg conversion rate, HBeAg seroconversion rate, HBV DNA conversion rate, HBsAg seroconversion rate, and ALT reversion rate at the end of 12 months of treatment and at 2 years of age.
Age
0 - 1 years
Sex
ALL
Healthy Volunteers
No
the Fifth Medical Center of PLA
Beijing, China
Start Date
August 1, 2024
Primary Completion Date
November 1, 2025
Completion Date
November 1, 2026
Last Updated
July 23, 2024
60
ESTIMATED participants
Lamivudine
DRUG
Interferon
DRUG
Lead Sponsor
Beijing 302 Hospital
NCT06671093
NCT07275554
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