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

Completed · Phase 1

Conditions studied: Sickle Cell Anemia

In brief

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.

Key facts

Study ID

NCT01506544

Run by

Children's Mercy Hospital Kansas City

People needed

39

Starts

2011-12-01

Expected to finish

2014-01-01

Last updated by the study team

2014-12-12

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A participant will not be eligible for inclusion in this study if any of the following criteria apply:
• Chronic transfusion therapy, or transfused within 3 months of study participation.
• Known renal impairment (creatinine greater than 1.5 times the upper limit of normal for age in the screening laboratory).
• Known hepatic impairment or elevated transaminases (greater than 3 times normal).
• Known presence of malignancy.
• The participant is unwilling and/or unable to abstain from use of tobacco- or nicotine-containing products for 24 hours prior to screening and for 24 hours prior to dosing until collection of the final PK sample during each treatment period.
• Diagnoses other than sickle cell anemia or sickle beta-zero thalassemia (i.e., other sickle cell variants or sickle hereditary persistence of fetal hemoglobin).
• Blood count parameters as follows: Hemoglobin less than 6.0 gm/dL, absolute reticulocyte count less than 80,000 mm-3, neutrophil count less than 1200 mm-3, platelet count less than 150,000 mm-3.
• The participant has used opiates, H2 blockers, proton pump inhibitors, antacids, other GI motility agents or any other medication that, in the opinion of the investigator and/or sponsor, will interfere with the study procedures or affect the interpretation of the results of the study for 3 days prior to the first dose of study.
• Use of over the counter non-steroidal anti-inflammatory agent or narcotic analgesic within 3 days.
• Participant has received an investigational drug within the past 30 days.
• Use of any illicit or illegal substances.
• The parent or guardian is unwilling or unable to provide a signed and dated written informed consent form prior to any study related procedures, or, when appropriate, the participant has refused to sign an assent to participate according to local IRB guidelines.
• Any other condition or chronic illness, which in the opinion of the Principal Investigator makes participation unadvised or unsafe.
• The caregiver is unwilling or unable to provide a completed study diary for a participant in the steady-state subset.

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States
• Children's Memorial Hospital (Northwestern University) — Chicago, Illinois, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• UT Southwestern University Hospital — Dallas, Texas, United States
• Children's Hospital of Wisconsin — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.