NCT03805581CompletedPhase 2
Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome
A Phase II Study to Determine the Safety of Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome
Source: ClinicalTrials.gov · Last updated 8 Dec 2023
Brief summary (registry, in English)
This study evaluates the safety of defibrotide in subjects with sickle cell disease (SCD)-associated acute chest syndrome (ACS).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 18 Dec 2018
- Start date
- 12 Jan 2018
- Primary completion date
- 1 Jul 2022
- Lead sponsor
- New York Medical College
- Diseases
- Sickle cell disease
- NCT number
- NCT03805581
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- From 12 Jan 2018 to the primary completion date, 1 Jul 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous hypersensitivity reaction to defibrotide;
- Current systemic anti-coagulant therapy and/or fibrinolytic therapy;
Other illness
- Current Grade III or IV hemorrhage;
Other
- Consent of patient/parent greater than 72 hours of inpatient admission for SCD-associated ACS;
- No signed informed consent
Who the study is looking for
- 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.
Age in the registry: 2 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| New York Medical College Coordinator of this site? Confirm its status | Valhalla | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.