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NCT07686770
Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease
Conditions: Kawasaki Disease
Sex: All
Ages: 29 Days – 17 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 90
Sponsor: Children's Hospital of Fudan University
Location: Jiangxi Provincial Children's Hospital Nanchang Jiangxi
Summary
This study evaluates the efficacy and safety of the addition of Firsekibart to standard initial treatment (intravenous immunoglobulin \[IVIG\] plus aspirin) in children with Acute Kawasaki Disease (KD) .
Eligibility Criteria
Inclusion Criteria:
1. Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2024
2. Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)
3. Not treated with IVIG yet
4. Age \>28 days，\ 3 times the upper limit of normal) prior to treatment
9. Unwillingness to provide written informed consent;
10. Unlikely to complete at least 3 months of follow-up;
11. Any other conditions deemed unsuitable for enrolment by investigators.
Source: ClinicalTrials.gov (NCT07686770). StuddyBuddy aggregates publicly available trial information.
