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Antithrombotic Agent

Defibrotide for Kawasaki Disease

Phase 2
Waitlist Available
Led By Mitchell S. Cairo, MD
Research Sponsored by New York Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of KD and initiation of defibrotide within 96 hours from the conclusion of IVIG treatment
Age: 0 - 11 years old
Must not have
Current systemic anti-coagulant therapy and/or fibrinolytic therapy, excluding aspirin (5 mg/kg/dose maximum)
History of Grade III or IV hemorrhage or active bleeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether defibrotide is safe to use with IVIG to treat children with Kawasaki disease who are at high risk for complications.

Who is the study for?
This trial is for children aged 0-11 with high-risk Kawasaki Disease, which can include boys, those under 6 months or over 8 years old, resistance to standard treatment (IVIG), prolonged fever before diagnosis, heart artery issues, or severe inflammation markers. They must not be on other experimental treatments for Kawasaki Disease and have no history of severe bleeding or hypersensitivity to defibrotide.
What is being tested?
The study tests the safety of using defibrotide in combination with IVIG therapy in children at high risk for complications from Kawasaki Disease. The goal is to see if this new approach improves outcomes compared to current treatments.
What are the potential side effects?
Potential side effects of defibrotide may include bleeding problems due to its effect on blood clotting. There's also a chance of allergic reactions since it's a biological agent. Specific side effects will be monitored closely given the young age group.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with Kawasaki Disease and started defibrotide within 4 days after my IVIG treatment ended.
Select...
I am 11 years old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am on blood thinners, but not taking more than 5 mg/kg of aspirin.
Select...
I have had severe bleeding in the past or have ongoing bleeding issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients with grade III/IV allergic reaction to defibrotide
Number of patients with grade III/IV hemorrhage attributable to defibrotide
Secondary study objectives
Number of patients with improvement in clinical progression/signs of Kawasaki disease

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT02876601
81%
Headache
38%
Flu-like Symptoms
19%
Chills
13%
Nausea
13%
Arthralgia
6%
Precollapse
6%
Dizziness
6%
Vertigo
100%
80%
60%
40%
20%
0%
Study treatment Arm
Defibrotide Plus LPS
Placebo Plus LPS
Defibrotide Plus Placebo
Placebo/Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionalExperimental Treatment1 Intervention
Defibrotide 6.25 mg/kg IV q6h
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Defibrotide
2018
Completed Phase 4
~2490

Find a Location

Who is running the clinical trial?

Columbia UniversityOTHER
1,491 Previous Clinical Trials
2,664,450 Total Patients Enrolled
New York UniversityOTHER
241 Previous Clinical Trials
220,321 Total Patients Enrolled
New York Medical CollegeLead Sponsor
71 Previous Clinical Trials
6,152 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,332 Previous Clinical Trials
14,874,898 Total Patients Enrolled
Mitchell S. Cairo, MDPrincipal InvestigatorNew York Medical College
2 Previous Clinical Trials
1,164 Total Patients Enrolled

Media Library

Defibrotide (Antithrombotic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04777422 — Phase 2
Kawasaki Disease Research Study Groups: Interventional
Kawasaki Disease Clinical Trial 2023: Defibrotide Highlights & Side Effects. Trial Name: NCT04777422 — Phase 2
Defibrotide (Antithrombotic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04777422 — Phase 2
~0 spots leftby Dec 2025
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