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NCT01506544 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics (PK) of Liquid Hydroxyurea in Pediatric Patients With Sickle Cell Anemia
A Phase 1 study of Sickle Cell Anemia, sponsored by Children's Mercy Hospital Kansas City.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 6
- Study locations
NCT01506544 is a Phase 1 study of Sickle Cell Anemia that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 39 participants, below the 99-participant average among 22 other Sickle Cell Anemia trials with a reported enrollment target (61% lower). The trial reports 6 study locations across 6 states.
The verdict
NCT01506544, a Phase 1 study of Sickle Cell Anemia, has completed, sponsored by Children's Mercy Hospital Kansas City.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 6
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 99-participant average among 22 other Sickle Cell Anemia trials with a reported enrollment target (61% lower). The listed sponsor is Children's Mercy Hospital Kansas City, which has 184 total studies on file at ClinicalTrials.gov.
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.
NCT01506544 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Alabama, Illinois, New York.
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.
What interventions are being tested in trial NCT01506544?
The interventions under investigation include: Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT01506544?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.