Phase 1
Completed N=24
Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis
Source: ClinicalTrials.gov NCT00412464 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: Number of Abnormal Lab Results Resulting in Adverse Events. — 0 Adverse Events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Abnormal Lab Results Resulting in Adverse Events. |
— | — |
| PRIMARY Therapeutic Plasma Concentration of Fondaparinux at 21 Days |
24 | — |
| PRIMARY Bleeding Events |
2 | — |
| PRIMARY Adverse Events |
— | — |
| PRIMARY Thrombocytopenic Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- Children between 1 year and 18 years of age.
- The presence of documented venous or arterial thrombosis confirmed by diagnostic imaging.
- Weight greater than 8.3 kg.
- Signed informed consent/assent.
Exclusion Criteria
- Patients with active bleeding.
- Patients with planned invasive procedures less than 2 weeks from the time of enrollment.
- Patients with a contraindication to anticoagulation.
- Patients receiving thrombolytic agents.
- Patients with an INR>1.5 or an activated partial thromboplastin time (PTT)>40 seconds.
- Patients with a creatinine level above 1.2 times the upper limit of normal expected for age.
- Children <1 year of age.
Data sourced from ClinicalTrials.gov (NCT00412464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.