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Antithrombotic Agent

Defibrotide for Sickle Cell 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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

This trial looks at whether it's safe to give the drug defibrotide to people who have sickle cell disease and are having a chest crisis.

Eligible Conditions
  • Sickle Cell Disease
  • Acute Chest Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with grade III/IV allergic reaction to defibrotide
Hemorrhage
Secondary outcome measures
Number of patients with improvement in clinical signs of Acute Chest Syndrome

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

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?

New York Medical CollegeLead Sponsor
69 Previous Clinical Trials
6,041 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,259 Previous Clinical Trials
14,820,633 Total Patients Enrolled
Mitchell S Cairo, MDPrincipal InvestigatorNew York Medical College
14 Previous Clinical Trials
1,148 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any prior examinations explored Defibrotide's efficacy?

"Presently, 4 clinical trials are evaluating the efficacy of Defibrotide. Unfortunately, none of these studies have reached Phase 3 yet. 9 medical sites scattered around Boston, Massachusetts host these investigations."

Answered by AI

Who is eligible to take part in this research initiative?

"This medical trial seeks to enrol 20 individuals aged between 2 and 40 who are suffering from acute chest syndrome. Eligible patients must possess two or more of the following symptoms: fever, respiratory discomfort, coughing, rapid breathing for their age group, pulmonary infiltration (evidenced by X-ray/CT scan) as well as a decreased oxygen saturation with or without supplemental O2; additionally, female participants within childbearing years will need to submit a negative pregnancy test result."

Answered by AI

Is the cohort for this research restricted to those under 60 years old?

"According to the requirements, potential trial subjects must be between 2 and 40 years old. 501 trials are available for minors while 1066 are aimed at senior citizens."

Answered by AI

Are there still openings for participants in this research endeavor?

"Per clinicaltrials.gov, this inquiry is not presently enrolling patients. The experiment commenced on the 12th of January 2018 and was last revised on 24th October 2022; nonetheless, at present there are 1,577 other medical trials actively recruiting participants."

Answered by AI

What is the current enrolment capacity for this trial?

"At the present moment, this clinical trial is not recruiting. When it was originally listed on December 1st 2018, its last update occured on October 24th 2022. For those interested in similar trials, 1573 studies are enrolling patients dealing with acute chest syndrome and 4 Defibrotide related ones as well."

Answered by AI

Does Defibrotide pose any risk to users?

"The safety of Defibrotide was assessed as a 2, since this clinical trial is still at Phase 2 and has yet to provide data on efficacy."

Answered by AI
~3 spots leftby Apr 2025