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Sponsored by: |
FDA Office of Orphan Products Development |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00412464 |
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.
Condition | Intervention | Phase |
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Thrombosis Heparin-Induced Thrombocytopenia |
Drug: Fondaparinux |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Pilot Dose-Finding and Pharmacokinetic Study of Fondaparinux in Children With Deep Vein Thrombosis or Heparin-Induced Thrombocytopenia |
Estimated Enrollment: | 24 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
This clinical trial will assess the pharmacokinetics and safety of the novel anticoagulant, fondaparinux sodium (Arixtra) in pediatric patients with thromboembolism. Currently available anticoagulants have significant limitations especially as it applies to the pediatric population. Thus novel agents with improved pharmacologic properties are needed to improve the care of this increasingly recognized complication in children. Furthermore, the only available agent for long-term anticoagulation in children with heparin-induced thrombocytopenia is warfarin. Anticoagulation with warfarin in the pediatric population is problematic due to its narrow therapeutic index and the numerous drug and food interactions necessitating frequent laboratory monitoring. In addition, oral administration of warfarin (which cannot be compounded to a liquid) is difficult in young children. Thus a novel agent for this condition is needed and fondaparinux does not cross-react with heparin antibodies. The aims of the study are to determine the proper dosing regimen (dose and interval) and safety in patients less than 18 years of age with thrombosis or heparin-induced thrombocytopenia. Another aim is to assess the utility of thromboelastography as a monitoring tool for patients on fondaparinux. This will be a pilot study which will enroll 24 patients in 3 age cohorts. Patients will receive an initial dose of 0.1mg/kg subcutaneoulsy daily.
After the first dose, fondaparinux levels will be drawn at 2,4,12, and 24 hours after administration. Dose adjustments will be made based on the 4 hour (peak) level and trough levels at 12 and 24 hours will determine if daily dosing is feasible. Thromboelastography will be performed at 2 or 4 hours and 24 hours with the results correlated with the plasma activity level. Safety will be assessed by physical examination, laboratory testing, and if necessary diagnostic imaging to determine the incidence of minor and major bleeding. Pharmacokinetic analyses as well as safety and efficacy determinations will be made which will provide valuable information on this promising new anticoagulant for pediatric patients.
Ages Eligible for Study: | 1 Year to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Guy Young, MD | 323-361-5507 | gyoung@chla.usc.edu |
Contact: Rachna Khanna | 323-361-2207 | rkhanna@chla.usc.edu |
United States, California | |
Children's Hospital Los Angeles | Recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Guy Young, MD 323-361-5507 gyoung@chla.usc.edu | |
Contact: Rachna Khanna 323-361-5507 rkhanna@chla.usc.edu | |
Principal Investigator: Guy Young, MD | |
Children's Hospital of Orange County | Recruiting |
Orange, California, United States, 92868 | |
Contact: Kathie Birschbach 714-532-8744 kjb0@choc.org | |
Principal Investigator: Diane J Nugent, MD | |
United States, Ohio | |
Nationwide Children's Hospital | Recruiting |
Columbus, Ohio, United States, 43205 | |
Contact: Sarah O'Brien, MD 614-722-6885 obriens@pediatrics.ohio-state.edu | |
Contact: Kami Perdue (614) 722-6885 kami.perdue@nationwidechildrens.org | |
United States, Texas | |
Texas Children's Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Donald Yee 832-824-4216 dlyee@txccc.org | |
Contact: Sarah McVey, BSN 832-824-4216 sjmcvey@txccc.org |
Principal Investigator: | Guy Young, MD | Children’s Hospital of Orange County |
Responsible Party: | Children's Hospital Los Angeles ( Guy Young ) |
Study ID Numbers: | 3091 |
Study First Received: | December 15, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00412464 History of Changes |
Health Authority: | United States: Food and Drug Administration |
fondaparinux thrombosis heparin-induced thrombocytopenia pediatrics |
Anticoagulants Hematologic Diseases Heparin Induced Thrombocytopenia Blood Platelet Disorders Vascular Diseases Fibrinolytic Agents Fondaparinux Cardiovascular Agents Thrombosis Org 31540 |
Calcium heparin Signs and Symptoms Thrombocytopathy Fibrin Modulating Agents Embolism and Thrombosis Thrombocytopenia Embolism Venous Thrombosis Heparin |
Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Diseases Blood Platelet Disorders Hematologic Agents Vascular Diseases Fibrinolytic Agents Fondaparinux Cardiovascular Agents |
Thrombosis Org 31540 Pharmacologic Actions Fibrin Modulating Agents Embolism and Thrombosis Thrombocytopenia Therapeutic Uses Cardiovascular Diseases |