Defibrotide in Children With High Risk Kawasaki Disease

Status unconfirmed · Phase 2

Conditions studied: Kawasaki Disease

In brief

This study evaluates the safety of defibrotide with IVIG in children with high risk Kawasaki disease.

Key facts

Study ID

NCT04777422

Run by

New York Medical College

People needed

2

Starts

2021-02-24

Expected to finish

2024-06-01

Last updated by the study team

2023-10-26

Who can join

Age: any, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Kawasaki disease presumptive diagnosis defined according AHA criteria;
• Signed informed consent and patient assent (if applicable)
• Diagnosis of KD and initiation of defibrotide within 96 hours from the conclusion of IVIG treatment
• Age: 0 - 11 years old
• High risk category defined as patient meeting ≥2 of the following criteria: male, age <6 months or >8yrs, IVIG-resistance, Fever lasting greater than 10 days, prior to diagnosis, Coronary artery aneurysms, and/or Laboratory tests indicating worse systemic inflammation
• PT and PTT within institutional normal limits
• Platelet count ≥100,000/mm3

You may not qualify if…

• History of Grade III or IV hemorrhage or active bleeding;
• Previous Grade II-IV hypersensitivity to defibrotide
• Current systemic anti-coagulant therapy and/or fibrinolytic therapy, excluding aspirin (5 mg/kg/dose maximum).
• Patients on an active experimental trial for Kawasaki disease

Where it is running

• Columbia University — New York, New York, United States
• New York University — New York, New York, United States
• Mitchell Cairo — Valhalla, New York, United States

Full record on ClinicalTrials.gov

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