EICHORCondition: Kawasaki Disease · Sponsor: Children's Hospital of Fudan University
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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) .
This description comes directly from the study's public registry record.
Fang Liu, MD · +86 021-64932800 · liufang@fudan.edu.cn
Lan He, MD · +8602164932026 · helan0361@163.com
There is no obligation to join — the study team can answer your questions about taking part.
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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，\<18 years Exclusion Criteria: 1. Receiving steroids or other immunosuppressive agents in the previous 30 days; 2. With a previous history of KD; 3. Afebrile before enrolment; 4. Contraindications for subcutaneous injection, including severe local skin infection, ulceration, etc; 5. Known hypersensitivity to immunoglobulins, Firsekibart, or any of the excipients; 6. With suspected infectious diseases including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza, etc; 7. With serious immune diseases, such as immunodeficiency, or chromosomal abnormalities; 8. With severe hepatic dysfunction (ALT \> 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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Jiangxi Provincial Children's Hospital | Nanchang, Jiangxi, China | — |
| Children's Hospital of Fudan University | Shanghai, Shanghai Municipality, China | — |
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Source record: clinicaltrials.gov/study/NCT07686770