Clinical trial
A Pilot Study to Determine the Safety of Defibrotide in Children With High Risk Kawasaki Disease
Name
NYMC-204
Description
This study evaluates the safety of defibrotide with IVIG in children with high risk Kawasaki disease.
Trial arms
Trial start
2021-02-24
Estimated PCD
2023-10-24
Trial end
2024-06-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Defibrotide
Defibrotide 6.25 mg/kg IV q6h up to 7 days
Arms:
Interventional
Other names:
Defitelio®
Size
2
Primary endpoint
Number of patients with grade III/IV allergic reaction to defibrotide
30 days
Number of patients with grade III/IV hemorrhage attributable to defibrotide
42 days
Eligibility 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
* 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2, 'type': 'ACTUAL'}}
Updated at
2023-10-26
1 organization
1 product
1 indication
Organization
New York Medical CollegeProduct
DefibrotideIndication
Kawasaki Disease