A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B

Launched by BEIJING 302 HOSPITAL · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well different antiviral treatments work for children aged 1 to 12 years who have chronic hepatitis B (a long-lasting infection caused by the hepatitis B virus, or HBV). The study will enroll a total of 2,000 children, including those who have never been treated before (1,600 kids) and those who have been treated (400 kids). The goal is to see which treatments are most effective and safe for these young patients.

To participate, children must meet specific requirements. They should be between 1 and 12 years old, have tested positive for the hepatitis B virus for more than six months, and, for the treatment group, have been on antiviral medication for more than a year. Parents or guardians must provide consent for their child to join, and if the child is 8 years or older, they will need to sign as well. The trial is not yet recruiting participants, but it will provide valuable insights into managing chronic hepatitis B in children, helping doctors make better treatment decisions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Initial Treatment Group:
• • 1. The guardian understands and signs the informed consent form (both parents must sign), and adheres to the relevant requirements of this study. If the participant is 8 years old or older, they must also sign the informed consent form. For participants under 8 years old who can express consent, their consent must be clearly documented.
• • 2. Age: ≥1 year and \<13 years, either sex;
• • 3. Positive for HBsAg and/or HBV DNA for more than 6 months;
• • 4. No prior antiviral treatment.
• * Treated Group:
• • 1. The guardian understands and signs the informed consent form (both parents must sign), and adheres to the relevant requirements of this study. If the participant is 8 years old or older, they must also sign the informed consent form. For participants under 8 years old who can express consent, their consent must be clearly documented.
• • 2. Age: ≥3 years and \<13 years, either sex;
• • 3. Previously diagnosed with chronic hepatitis B and received antiviral treatment with NAs for more than 1 year and currently on treatment;
• • 4. No history of IFNα use in the past 6 months;
• • 5. Negative for HBV DNA;
• • 6. HBsAg quantification \<10,000 IU/ml (HBsAg can be negative in the drug discontinuation observation group);
• • 7. The drug discontinuation observation group must also achieve negative HBV DNA and HBeAg seroconversion for at least 1 year (based on continuous results from three consecutive reviews), and HBsAg \<10,000 IU/ml; NAs will be discontinued after enrollment.
• Exclusion Criteria:
• • 1.In the interferon group, blood white blood cell count \<3.5×10\^9/L, or platelet count \<80×10\^9/L, or prothrombin activity \<60%, or total bilirubin \>34μmol/L, or serum albumin \<35g/L, or serum creatinine \>133μmol/L; 2.Coexistence of other active infections; 3. Coexistence of other chronic liver diseases or active liver diseases, such as autoimmune liver disease, drug-induced liver injury, Wilson's disease, decompensated cirrhosis, liver cancer; 4. Coexistence of other severe systemic diseases or malignant tumors, etc.; 5. History of allergy to nucleoside analogues or interferon; 6. Subjects whom the investigator deems to have poor compliance, unable or unwilling to provide informed consent, or unable to adhere to the study requirements, or other conditions not suitable for participation in this study.