Pharmacokinetics (PK) of Liquid Hydroxyurea in Pediatric Patients With Sickle Cell Anemia
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)