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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: Completed Phase 1 study of Sickle Cell Anemia, sponsored by Children's Mercy Hospital Kansas City.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cmax, Area Under Curve, Tmax. Also, the following pharmacokinetic parameters will be derived for each participant using standard techniques: Apparent absorption rate constant, Apparent terminal elimination rate constant, Apparent steady state volume of distribution, Apparent plasma clearance. A compartment, model-based, classical fitting paradigm of the plasma concentration vs. time data will be applied to each subjects' data. Standard goodness of fit criteria will be employed. Subjects aged gre
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 |
What the finished NCT01506544 record still lists
NCT01506544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 99-participant average among 22 other Sickle Cell Anemia trials with a reported enrollment target (61% lower).
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 lists 6 locations in 6 states (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.
Learn More About Clinical Trials
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Where NCT01506544's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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