Antiviral Therapy in Infants With HBV Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HBV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

the antiviral group and the control group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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the antiviral group

HBV-infected infants in the treatment group were treated with LAM (4 mg/kg/d) before 1 year of age, and then combined with regular interferon (intramuscular or subcutaneous injection, 3-6 million U/m2 body surface area, every other day, with a starting dose of 3 million U/m2 body surface area, which was adjusted according to the specific tolerances of the children during the course of the treatment) if they were still HBV DNA and/or HBsAg-positive at the end of the 1st year of age. The course of interferon treatment is 52 weeks.

Group Type EXPERIMENTAL

Lamivudine

Intervention Type DRUG

4mg/kg/d, oral

Interferon

Intervention Type DRUG

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.

the control group

synchronized follow-up visits without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lamivudine

4mg/kg/d, oral

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No