Antiviral Therapy in Infants With HBV Infection

Beijing 302 Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: HBV

Treatments: Drug: Lamivudine; Drug: Interferon

Study type: Interventional

Funder types: Other

Identifiers

NCT06503796

KY-2023-12-85-1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

the antiviral group

Experimental group

Description:

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.

Treatment:

Drug: Interferon

Drug: Lamivudine

the control group

No Intervention group

Description:

synchronized follow-up visits without intervention