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Clinical Trials in China / NCT06503796
Starting soon Phase 4

Antiviral Therapy in Infants With HBV Infection

NCT06503796 · tracked via the Priya Life Science China tracker
Sponsor
Beijing 302 Hospital
Phase
Phase 4
Started
2024-08
Last updated
2024-07-23

Condition(s) studied

HBV

Investigational drug(s) / intervention(s)

Lamivudine →Interferon →

Lamivudine: 4mg/kg/d, oral

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.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
1 Year
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
the Fifth Medical Center of PLA Beijing China

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Other trials for the same condition

Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy Starting soon
Real-world Study on Liver Cancer Risk in Chronic Hepatitis B Patients With Family History of Liver Cancer Starting soon
Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA. Recruiting
A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B Starting soon
Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients With Chronic Hepatitis B Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06503796 on ClinicalTrials.gov ↗ ← All trials in China