At a glance
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A Pilot Dose-finding and Pharmacokinetic Study of Fondaparinux in Children With Deep Vein Thrombosis or Heparin-induced Thrombocytopenia
In Brief
A Phase 1 clinical trial evaluating Fondaparinux for Thrombosis and Heparin-induced Thrombocytopenia. Completed, enrolled 24 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
Fondaparinux 0.1 mg/kg (up to 7.5 mg max initial dose) once daily for up to 21 days.