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NCT Number: NCT06503796

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.

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Key information

Conditions

HBV

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lamivudine

Drug

4mg/kg/d, oral

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.

Primary outcomes

  1. The rate of HBsAg loss

    Time frame: 12months after intervention, 2 years old

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

Secondary outcomes

  1. The rate of HBsAg seroconversion

    Time frame: 12months after intervention, 2 years old

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

  2. The rate of HBV DNA loss

    Time frame: 12months after intervention, 2 years old

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

  3. The rate of HBeAg loss

    Time frame: 12months after intervention, 2 years old

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

  4. The rate of HBeAg seroconversion

    Time frame: 12months after intervention, 2 years old

    The rate of HBeAg seroconversion in 12months after intervention, 2 years old

  5. ALT reversion rate

    Time frame: 12months after intervention, 2 years old

    ALT reversion rate in 12months after intervention, 2 years old

  6. Incidence of Treatment-Emergent Adverse Events

    Time frame: 12months after intervention, 2 years old

    Safety and Tolerability of Antiviral Therapy in infants

Study contacts

Contact information is provided by the study sponsor or research team.

Junliang Fu, PhD, MD

CONTACT

[email protected]

86-10-66933214

Sponsors and collaborators

Lead sponsor

Beijing 302 Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 16, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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