A Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG Treatment

Recruiting Phase 3 Interventional Study
Kawasaki Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
3 Months – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
84 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
Kawasaki disease (KD) is the most frequent vasculitis in younger children \<5years, and the first cause of acquired ischemic myocardiopathy in childhood. Exceptionally, KD may cause early death during the acute phase by myocardial infarction, but may compromise the long-term cardiovascular outcome by accelerating atherosclerotic disease. The incidence of KD is high in far-Eastern countries and Ha…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Children, male and female, from 3 months to \<18 years old * Patient ≥ 5 kg * Patient with KD according to the American Heart Association definition for complete or incomplete KD. (Fever ≥ 5 days (or at least 3 days if KD with American Heart Association criteria since the thir…
Contacts

Isabelle Koné-Paut, Pr

00 33 1 45 21 32 46

isabelle.kone-paut@aphp.fr

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