Defibrotide in Children With High Risk Kawasaki Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2024-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Kawasaki Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional

Defibrotide 6.25 mg/kg IV q6h

Group Type EXPERIMENTAL

Defibrotide

Intervention Type DRUG

Defibrotide 6.25 mg/kg IV q6h up to 7 days

Interventions

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Defibrotide

Defibrotide 6.25 mg/kg IV q6h up to 7 days

Intervention Type DRUG

Other Intervention Names

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Defitelio®

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No