Antiviral Therapy in Infants With HBV Infection

Phase 4

Not yet recruiting

• Conditions: HBV
• Interventions: Drug: Lamivudine; Drug: Interferon

• Registration Number: NCT06503796
• Lead Sponsor: Beijing 302 Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-16
• Last Update Submitted: 2024-07-21
• Last Update Posted: 2024-07-23
• Study Start: 2024-08
• Primary Completion: 2025-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the antiviral group	Interferon	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.
the antiviral group	Lamivudine	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.

Primary Outcome Measures

Name	Time	Method
The rate of HBsAg loss	12months after intervention, 2 years old	The rate of HBsAg loss in 12months after intervention, 2 years old

Secondary Outcome Measures

Name	Time	Method
The rate of HBsAg seroconversion	12months after intervention, 2 years old	The rate of HBsAg seroconversion in 12months after intervention, 2 years old
The rate of HBV DNA loss	12months after intervention, 2 years old	The rate of HBV DNA loss in 12months after intervention, 2 years old
The rate of HBeAg loss	12months after intervention, 2 years old	The rate of HBeAg loss in 12months after intervention, 2 years old
The rate of HBeAg seroconversion	12months after intervention, 2 years old	The rate of HBeAg seroconversion in 12months after intervention, 2 years old
ALT reversion rate	12months after intervention, 2 years old	ALT reversion rate in 12months after intervention, 2 years old
Incidence of Treatment-Emergent Adverse Events	12months after intervention, 2 years old	Safety and Tolerability of Antiviral Therapy in infants

Trial Locations

Locations (1)

the Fifth Medical Center of PLA; 🇨🇳 Beijing, China