Status:
UNKNOWN
Defibrotide in Children With High Risk Kawasaki Disease
Lead Sponsor:
New York Medical College
Collaborating Sponsors:
Johns Hopkins University
Columbia University
Conditions:
Kawasaki Disease
Eligibility:
All Genders
Up to 11 years
Phase:
PHASE2
Brief Summary
This study evaluates the safety of defibrotide with IVIG in children with high risk Kawasaki disease.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04777422
Start Date
February 24 2021
End Date
June 1 2024
Last Update
October 26 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University
New York, New York, United States, 10032
2
New York University
New York, New York, United States, 10032
3
Mitchell Cairo
Valhalla, New York, United States, 10595-1524