Pharmacokinetics (PK) of Liquid Hydroxyurea in Pediatric Patients With Sickle Cell Anemia

Clinical Trial
Study Details
Enrollment
39
Interventions
Description

20mg/kg of Hydroxyurea or the patient's standard daily dose

Name
Hydroxyurea
Type
Drug
Phase
Phase 1
Status
COMPLETED
Study ID #
NCT01506544
Study Type
Interventional
Summary

Hydroxyurea (HU) is approved by the United States Food and Drug Administration (FDA) to treat adults with sickle cell anemia. Hydroxyurea has also been tested and used with children with sickle cell anemia. However, there are not many studies describing the disposition of drug in children less than 5 years old. The FDA has requested this study to better understand how children ages 2 to 17 years with sickle anemia absorb and eliminate the drug (this is called pharmacokinetics). The investigators will measure how much Hydroxyurea (HU) gets into the bloodstream at different time points after taking this medication.

Study Overview
Conditions
Contacts and Locations
Locations
Facility

Children's Hospital of Alabama
Birmingham, Alabama 35233
United States

GeoPoint
33.52066, -86.80249
Facility

Children's Memorial Hospital (Northwestern University)
Chicago, Illinois 60614-3363
United States

GeoPoint
41.85003, -87.65005
Facility

Columbia University Medical Center
New York, New York 10032
United States

GeoPoint
40.71427, -74.00597
Facility

Duke University Medical Center
Durham, North Carolina 27710
United States

GeoPoint
35.99403, -78.89862
Facility

UT Southwestern University Hospital
Dallas, Texas 75390-9063
United States

GeoPoint
32.78306, -96.80667
Facility

Children's Hospital of Wisconsin
Wauwatosa, Wisconsin 53226
United States

GeoPoint
43.04946, -88.00759