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Pharmacokinetics (PK) of Liquid Hydroxyurea in Pediatric Patients With Sickle Cell Anemia
NCT01506544 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Hydroxyurea
Study Locations (6)
Alabama
- Children's Hospital of Alabama — Birmingham
Illinois
- Children's Memorial Hospital (Northwestern University) — Chicago
New York
- Columbia University Medical Center — New York
North Carolina
- Duke University Medical Center — Durham
Texas
- UT Southwestern University Hospital — Dallas
Wisconsin
- Children's Hospital of Wisconsin — Wauwatosa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01506544
The ClinicalTrials.gov registry entry for NCT01506544 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Mercy Hospital Kansas City, which has 93 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Sickle Cell Anemia appearing as the primary indexed condition, and to 1 intervention — of which Hydroxyurea is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01506544 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Alabama, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01506544 about?
NCT01506544 is a clinical study titled "Pharmacokinetics (PK) of Liquid Hydroxyurea in Pediatric Patients With Sickle Cell Anemia". 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 ...
What is the current status of trial NCT01506544?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2011-12. Estimated completion is 2014-01.
What conditions does trial NCT01506544 study?
This clinical trial studies the following conditions: Sickle Cell Anemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01506544?
The interventions under investigation include: Hydroxyurea (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01506544?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 93 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01506544 being conducted?
This trial has 6 study locations across Alabama, Illinois, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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