Antiviral Therapy in Infants With HBV Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lamivudine, Interferon.
- Who it may be relevant to
- Registry conditions: HBV. Basic parameters: up to 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Lamivudine
4mg/kg/d, oral - Drug Interferon
Use only in children who remain positive for HBV-DNA and/or HBsAg after 1 year of age. Regular interferon (3 million U/m2 body surface area, intramuscular or subcutaneous, every other day, adjusted during treatment according to the child's specific tolerance) for 52 weeks.
Primary outcome measures
- The rate of HBsAg loss [Time frame: 12months after intervention, 2 years old]
Secondary outcome measures (6)
- The rate of HBsAg seroconversion [Time frame: 12months after intervention, 2 years old]
- The rate of HBV DNA loss [Time frame: 12months after intervention, 2 years old]
- The rate of HBeAg loss [Time frame: 12months after intervention, 2 years old]
- The rate of HBeAg seroconversion [Time frame: 12months after intervention, 2 years old]
- ALT reversion rate [Time frame: 12months after intervention, 2 years old]
- Incidence of Treatment-Emergent Adverse Events [Time frame: 12months after intervention, 2 years old]
Eligibility criteria
Inclusion criteria
- a. Age ≤ 1 year;
- b. HBsAg and HBV DNA positive;
- c. ALT ≤ 5 times the upper limit of normal (ULN) and no pathologic jaundice (two consecutive tests with an interval of 2 weeks - 3 months).
- d. Parents are willing to participate in the study and sign an informed consent form, for children without parents, all legal guardians of need to give informed consent.
Exclusion criteria
- a. Combined viral infections such as HAV, HCV, HDV, HEV, HIV, EBV, CMV, etc;
- b. Combination of other liver diseases, such as autoimmune hepatitis, drug-induced liver injury, Wilson's disease;
- c. WBC <9 × 10\^9/L, or PLT <90 × 10\^9/L;
- d. Combination of other systemic serious diseases or hereditary diseases, etc;
- e. Other conditions deemed by the investigator to be unsuitable for participation in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- the Fifth Medical Center of PLA — Beijing
Identifiers
NCT: NCT06503796 · KY-2023-12-85-1