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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03805581
Other study ID # NYMC-192
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 12, 2018
Est. completion date November 7, 2023

Study information

Verified date December 2023
Source New York Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the safety of defibrotide in subjects with sickle cell disease (SCD)-associated acute chest syndrome (ACS).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 7, 2023
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years to 40 Years
Eligibility Inclusion Criteria: - SCD-associated ACS with the presence of any two or more of the following signs not explained by other etiologies: Fever, Chest pain, Cough, Dyspnea, Tachypnea for age, Pulmonary infiltrate on CXR and/or Chest CT scan, Decreased O2 saturation with or without oxygen supplement; - Age 2 to 40 years of age; - Homozygous Hemoglobin S Disease, Hemoglobin SC Disease or Hemoglobin S 0/+ thalassemia; - Informed consent/assent; - Consent of patient/parent within =72 hours after inpatient admission for SCD-associated ACS. - Females of childbearing age will have a negative pregnancy test. Exclusion Criteria: - Current Grade III or IV hemorrhage; - Previous hypersensitivity reaction to defibrotide; - Current systemic anti-coagulant therapy and/or fibrinolytic therapy; - Consent of patient/parent greater than 72 hours of inpatient admission for SCD-associated ACS; - No signed informed consent

Study Design


Intervention

Drug:
Defibrotide
Defibrotide 6.25 mg/kg IV q6h up to 7 days

Locations

Country Name City State
United States New York Medical College Valhalla New York

Sponsors (2)

Lead Sponsor Collaborator
New York Medical College Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with grade III/IV allergic reaction to defibrotide All patients will be monitored for allergic reaction probably or definitely related to defibrotide administration. 30 days
Primary Number of patients with grade III/IV hemorrhage All patients will be monitored for hemorrhage probably or definitely related to defibrotide. 30 days
Secondary Number of patients with improvement in clinical signs of Acute Chest Syndrome Patients will have pre and post treatment assessments with imaging and blood tests to monitor clinical signs of ACS 30 days
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