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Defibrotide for Kawasaki Disease
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 4 trial • 20 Patients • NCT02876601Trial Design
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Who is running the clinical trial?
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- You are currently participating in a research study for Kawasaki disease.I was diagnosed with Kawasaki Disease and started defibrotide within 4 days after my IVIG treatment ended.You have symptoms that suggest Kawasaki disease, as defined by the American Heart Association.Your platelet count is at least 100,000 per cubic millimeter.I am on blood thinners, but not taking more than 5 mg/kg of aspirin.I have had severe bleeding in the past or have ongoing bleeding issues.I am considered high risk due to having at least two specific health factors.You had a moderate to severe allergic reaction to defibrotide before.I am 11 years old or younger.Your blood clotting tests are within the normal range at the hospital.
- Group 1: Interventional
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What type of participants is best suited for this clinical investigation?
"To be eligible for admission, patients must have mucocutaneous lymph node syndrome and lie within the 0-11 age range. A total of 20 participants are being accepted into this clinical trial."
Has the FDA authorized Defibrotide for medical use?
"Defibrotide's safety is supported by some clinical data, thus earning a score of 2 on our team at Power's numerical scale. Unfortunately, there has not been any studies conducted to determine its efficacy."
Is the research protocol inclusive of geriatric individuals?
"The age qualifications for this experimental therapy are between infancy and pre-adolescence. There is also a total of 8 trials available to minors, as well as two clinical studies specifically designed for geriatric patients."
Are there any other research initiatives that have explored the effects of Defibrotide?
"Presently, 4 trial studies revolving around Defibrotide are in progress. None of these investigations have reached Phase 3 yet and most take place in Boston, however 9 sites across the world are participating."
What is the upper bound to participant enrollment in this trial?
"Affirmative. The clinical trial's page on clinicaltrials.gov confirms that this clinical investigation is presently recruiting participants, which began being sought after the 24th of February 2021 and was last updated near the end of October 2021. 20 individuals across 3 sites need to be enrolled in order for the study to commence its operations."
Is it still possible to join this research endeavor?
"Affirmative. Data hosted on clinicaltrials.gov attests to this medical trial's active recruitment of participants, which commenced on February 24th 2021 and was recently updated October 29th 2021. 20 individuals are required from 3 distinct research centres."
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