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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04777422
Other study ID # NYMC-204
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date February 24, 2021
Est. completion date June 2024

Study information

Verified date October 2023
Source New York Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2
Est. completion date June 2024
Est. primary completion date October 24, 2023
Accepts healthy volunteers No
Gender All
Age group 0 Years to 11 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Defibrotide
Defibrotide 6.25 mg/kg IV q6h up to 7 days

Locations

Country Name City State
United States Columbia University New York New York
United States New York University New York New York
United States Mitchell Cairo Valhalla New York

Sponsors (4)

Lead Sponsor Collaborator
New York Medical College Columbia University, Johns Hopkins University, New York University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with grade III/IV allergic reaction to defibrotide All patients will be monitored for allergic reaction probably or definitely related to defibrotide administration. 30 days
Primary Number of patients with grade III/IV hemorrhage attributable to defibrotide All patients will be monitored for hemorrhage probably or definitely related to defibrotide. 42 days
Secondary Number of patients with improvement in clinical progression/signs of Kawasaki disease Patients will have pre and post treatment assessments with imaging and blood tests to monitor clinical signs of Kawasaki disease 42 days
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