Defibrotide in Children With High Risk Kawasaki Disease

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York Medical College
• Collaborators: Columbia University; Johns Hopkins University; New York University
• Treatments: Defibrotide

Criteria

Inclusion Criteria:

• 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

• Patients must be ineligible for or refused to participate in the Kawasaki Disease Comparative Effectiveness (KIDCARE) study.

• PT and PTT within institutional normal limits

• Platelet count ≥100,000/mm3

Exclusion Criteria:

• 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