Defibrotide in Children With High Risk Kawasaki Disease

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Brief Title

Defibrotide in Children With High Risk Kawasaki Disease

Official Title

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

Brief Summary

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


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of patients with grade III/IV allergic reaction to defibrotide

Secondary Outcome

 Number of patients with improvement in clinical progression/signs of Kawasaki disease

Condition

Kawasaki Disease

Intervention

Defibrotide

Study Arms / Comparison Groups

 Interventional
Description:  Defibrotide 6.25 mg/kg IV q6h

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

February 24, 2021

Completion Date

June 2024

Primary Completion Date

March 2024

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

          -  Patients must be ineligible for or refused to participate in the Kawasaki Disease
             Comparative Effectiveness (KIDCARE) study.

          -  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
      

Gender

All

Ages

0 Years - 11 Years

Accepts Healthy Volunteers

No

Contacts

, 914-594-2150, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04777422

Organization ID

NYMC-204


Responsible Party

Sponsor

Study Sponsor

New York Medical College

Collaborators

 Johns Hopkins University

Study Sponsor

, , 


Verification Date

October 2021