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NCT00412464 · ClinicalTrials.gov registry record · Phase 1
Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis
A Phase 1 study, sponsored by Children's Hospital Los Angeles.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00412464 is a Phase 1 study that has completed, run by Children's Hospital Los Angeles. The registered enrollment target is 24 participants.
The verdict
NCT00412464, a Phase 1 study, has completed, sponsored by Children's Hospital Los Angeles.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study will evaluate the use of a blood thinner, fondaparinux, which is approved for use in adults (not in children) in a children aged 1-18 years. Subject with a blood clot (thrombosis) or heparin-induced thrombocytopenia who need to be on a blood thinner will be eligible to participate. Subjects will receive a once daily dose of fondaparinux followed by blood tests at 2, 4, 12, and 24 hours after the first dose in order to determine the proper dose for this age group. The hypothesis is that children receiving fondaparinux will be able to receive a once daily dose. The currently available alternative agent, enoxaparin, needs to be given twice daily. In addition, an evaluation of the safety of this medication will be made by assessing for side effects, especially bleeding.
Interventions
- DRUG Fondaparinux
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00412464
The ClinicalTrials.gov registry entry for NCT00412464 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fondaparinux is the first listed.
NCT00412464 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00412464 about?
NCT00412464 is a clinical study titled "Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis". This study will evaluate the use of a blood thinner, fondaparinux, which is approved for use in adults (not in children) in a children aged 1-18 years. Subject with a blood clot (thrombosis) or heparin-induced thrombocytopenia who need to be on a blood thinner will be eligible to participate. Subjec...
What is the current status of trial NCT00412464?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2006-09. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00412464?
The interventions under investigation include: Fondaparinux (DRUG).
Who is sponsoring clinical trial NCT00412464?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
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