Antiviral Therapy in Infants With HBV Infection

Launched by BEIJING 302 HOSPITAL · Jul 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of antiviral therapy in infants who have a hepatitis B virus (HBV) infection. The main goal is to see if treating these young patients with a specific medication, called LAM, can help improve their health by reducing the virus in their bodies. The study will involve 60 infants under the age of one who have tested positive for HBV but are not severely ill. Eligible infants must also have normal liver function levels and no serious liver conditions or other infections.

Participants in the trial will be divided into two groups: one group will receive the antiviral treatment, while the other group will not receive any treatment during the study period. Both groups will be monitored closely every three months for a year. The researchers will look at several important health markers to determine how effective the treatment is. Parents or guardians of eligible infants who choose to participate will need to give their consent for their child to be part of the study. This trial is not yet recruiting participants but aims to help improve treatment options for infants with HBV infection.

Gender

ALL

Eligibility criteria

• 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.