Sickle Cell Disease Clinical Trial
Official title:
A Phase II Study to Determine the Safety of Defibrotide in Sickle Cell Disease-Related Acute Chest Syndrome
Verified date | December 2023 |
Source | New York Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the safety of defibrotide in subjects with sickle cell disease (SCD)-associated acute chest syndrome (ACS).
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 |
Country | Name | City | State |
---|---|---|---|
United States | New York Medical College | Valhalla | New York |
Lead Sponsor | Collaborator |
---|---|
New York Medical College | Johns Hopkins University |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02227472 -
Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease
|
||
Recruiting |
NCT06301893 -
Uganda Sickle Surveillance Study (US-3)
|
||
Recruiting |
NCT04398628 -
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
|
||
Completed |
NCT02522104 -
Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)
|
Phase 4 | |
Recruiting |
NCT04688411 -
An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease
|
N/A | |
Terminated |
NCT03615924 -
Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease
|
Phase 3 | |
Not yet recruiting |
NCT06300723 -
Clinical Study of BRL-101 in Severe SCD
|
N/A | |
Recruiting |
NCT03937817 -
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|
||
Completed |
NCT04134299 -
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease
|
N/A | |
Completed |
NCT04917783 -
Health Literacy - Neurocognitive Screening in Pediatric SCD
|
N/A | |
Completed |
NCT02580565 -
Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide and Analgesics in the Sickle-cell Disease
|
||
Recruiting |
NCT04754711 -
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
|
N/A | |
Completed |
NCT04388241 -
Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD
|
N/A | |
Recruiting |
NCT05431088 -
A Phase 2/3 Study in Adult and Pediatric Participants With SCD
|
Phase 2/Phase 3 | |
Completed |
NCT01158794 -
Genes Influencing Iron Overload State
|
||
Recruiting |
NCT03027258 -
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
|
N/A | |
Withdrawn |
NCT02960503 -
Macrolide Therapy to Improve Forced Expiratory Volume in 1 Second in Adults With Sickle Cell Disease
|
Phase 1/Phase 2 | |
Completed |
NCT02565082 -
Evaluation of the Hemostatic Potential in Sickle Cell Disease Patients
|
N/A | |
Completed |
NCT02567682 -
Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT02620488 -
A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease
|
N/A |