Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Paediatric Subjects with an Indwelling Central Venous Catheter
- Conditions
- Venous ThromboembolismVein blockage due to clot10014523
- Registration Number
- NL-OMON36556
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 4
1) Signed Written Informed Consent obtained from subject or subject*s legally acceptable representative (parents or guardians) according to local regulations and if mentally capable, assent from subject if required locally.
2) Subjects with stable disease with any type of functioning CVC in the upper or
lower venous system (e.g., jugular, subclavian; femoral vein) that is anticipated to
remain in the subject for the treatment portion of the study.
3) Male and female subjects > 37 weeks to <18 years of age
1) Current or recent (within 3 months of study drug administration) gastrointestinal
disease or gastrointestinal surgery that could impact the absorption of the study drug (i.e. severe diarrhoea, ileus, or malabsorption syndrome).
2) Inability to tolerate oral medication or administration of medication via an enteral
tube
3) Inability to tolerate central venous access.
4) Heparin-coated CVC
5) History or evidence of abnormal bleeding or coagulation disorder including those
in a first-degree relative
6) Any condition, in the opinion of the investigator, for which surgery is needed or
administration of an anticoagulant is contraindicated.
7) Presently receiving or the need for ongoing treatment with an anticoagulant or
antiplatelet agent.
8) Treatment with a potent inhibitor or inducer of CYP3A4 or P-gp within 2 weeks
of enrolment.
9) Any other sound medical, psychiatric and/or social reason as determined by the
investigator.
10) Abnormal baseline lab test findings as defined by the protocol
11) Evidence of organ dysfunction or any clinically significant deviation from normal
in physical examination, vital signs, or clinical laboratory determinations beyond
what is consistent with the target population.
12) History of allergy to apixaban or Factor Xa inhibitors or any other significant drug allergy (such as anaphylaxis or hepatotoxicity).
13) History of significant adverse reaction or major bleeding related adverse reaction
to other anticoagulant or antiplatelet agents
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint:<br /><br>* Pharmacokinetic Measures: Model-derived population and individual<br /><br>pharmacokinetic parameters<br /><br>(e.g., CL/F, Vc/F, KA) will be used to estimate steady state Cmax and AUC(TAU),<br /><br>Cmin and Tmax in<br /><br>each subject. The population PK model will be developed using plasma<br /><br>concentration versus time<br /><br>data.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacodynamic Measures: The pharmacodynamics of apixaban will be<br /><br>characterised using the same PPK-PD model as that for PK endpoints and will be<br /><br>developed using both the plasma concentration and the measured Anti-Xa activity<br /><br>versus time data<br /><br>* Safety Outcome Measures: Safety assessments will be based on medical review<br /><br>of adverse event reports and the results of vital sign measurements, physical<br /><br>examinations, and clinical laboratory tests. The incidence of adverse events<br /><br>will be tabulated and reviewed for potential significance and clinical<br /><br>importance.</p><br>