Defibrotide in Children With High Risk Kawasaki Disease

Kawasaki Disease Clinical Trial

Official title:

A Pilot Study to Determine the Safety of Defibrotide in Children With High Risk Kawasaki Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04777422
• Other study ID #: NYMC-204
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

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