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Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease
Sponsor: Children's Hospital of Fudan University
Summary
This study evaluates the efficacy and safety of the addition of Firsekibart to conventional initial treatment (intravenous immunoglobulin \[IVIG\] plus aspirin) in children with Acute Kawasaki Disease (KD) .
Official title: Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease: An Exploratory Randomized Controlled Study
Key Details
Gender
All
Age Range
29 Days - 17 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-08-01
Completion Date
2028-02-01
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
IVIG
IVIG 2g/kg once, given within 8 to 12 hours, with the maximum dose of 60g.
Aspirin
Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
Firsekibart
Firsekibart 3 mg/kg by a single subcutaneous injection prior to IVIG infusion. After a 30-minute observation period confirming the absence of adverse reactions, the IVIG infusion is initiated.
Locations (2)
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China