Antiviral Therapy in Infants With HBV Infection

NCT06503796 | Not Yet Recruiting Phase 4

• 1 other identifier: KY-2023-12-85-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HBV

Outcome Measures

Primary Outcomes (1)

• The rate of HBsAg loss

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

  12months after intervention, 2 years old

Secondary Outcomes (6)

• The rate of HBsAg seroconversion

  12months after intervention, 2 years old

• The rate of HBV DNA loss

  12months after intervention, 2 years old

• The rate of HBeAg loss

  12months after intervention, 2 years old

• The rate of HBeAg seroconversion

  12months after intervention, 2 years old

• ALT reversion rate

  12months after intervention, 2 years old

Study Arms (2)

the antiviral group

EXPERIMENTAL

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; Drug: Interferon

the control group

NO INTERVENTION

synchronized follow-up visits without intervention

Interventions

Lamivudine DRUG

4mg/kg/d, oral

the antiviral group

Interferon 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 antiviral group

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

the Fifth Medical Center of PLA

Beijing, China

Location

MeSH Terms

Interventions

Lamivudine; Interferons

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Junliang Fu

  The fifth medical center of PLA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junliang Fu, PhD, MD

CONTACT

86-10-66933214; fjunliang@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the antiviral group and the control group

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: August 1, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)