Antiviral Therapy in Infants With HBV Infection

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HBV
• Intervention / Treatment: Drug: Lamivudine; Drug: Interferon

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Junliang Fu, PhD, MD; Phone Number: 86-10-66933214; Email: fjunliang@163.com

Study Locations

• China
  • Beijing, China
    • The fifth medical center of PLA
    • Contact: Fu-Sheng Wang, PhD, MD; Phone Number: 86-10-66933328; Email: fswang302@163.com
    • Contact: Junliang Fu, PhD, MD; Phone Number: 86-10-66933214

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: the control group; synchronized follow-up visits without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of HBsAg loss	The rate of HBsAg loss in 12months after intervention, 2 years old	12months after intervention, 2 years old

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing 302 Hospital
• Investigators: Principal Investigator: Junliang Fu, The fifth medical center of PLA

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antineoplastic Agents; Interferons; Lamivudine
• Other Study ID Numbers: KY-2023-12-85-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No