A Phase II Study to Determine the Safety of Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome

About the study

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

Study point of contact

Mitchell S Cairo, MD
9145972150
[email protected]
Erin Morris, RN
7149645359
[email protected]

Locations

1 United States site

Age

2 Years - 40 Years

Genotypes

Hemoglobin SC

Phase

Phase 2

Study type

Interventional

Gender

All

Interventions

Drug

participation requirements

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.

participation restrictions

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

Locations

  • Valhalla, New York, United States, New York Medical College
Last updated 2021-11-18