Defibrotide in Children With High Risk Kawasaki Disease

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04777422

Enrollment

Registered

2021-03-02

Start date

2021-02-24

Completion date

2024-06-30

Last updated

2023-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kawasaki Disease

Keywords

Kawasaki, Children, Defibrotide

Brief summary

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

Interventions

DRUGDefibrotide

Defibrotide 6.25 mg/kg IV q6h up to 7 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Years to 11 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with grade III/IV allergic reaction to defibrotide	30 days	All patients will be monitored for allergic reaction probably or definitely related to defibrotide administration.
Number of patients with grade III/IV hemorrhage attributable to defibrotide	42 days	All patients will be monitored for hemorrhage probably or definitely related to defibrotide.

Secondary

Measure	Time frame	Description
Number of patients with improvement in clinical progression/signs of Kawasaki disease	42 days	Patients will have pre and post treatment assessments with imaging and blood tests to monitor clinical signs of Kawasaki disease

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026