CV185118 - Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder (IRB# 41107)
- Principal Investigator: Andrew S. Freiberg, MD
In children, ninety-six percent of Venous thromboembolism or VTEs occur in association with serious underlying illness such as cancer and congenital heart disease or surgery with usually 1 or more other acquired or congenital risk factors. Children with significant cardiac disease such as those with Fontan procedures, mechanical heart valves, single ventricles, primary pulmonary hypertension, and giant coronary aneurysm secondary to Kawasaki Disease often require years of anticoagulation with a medication (vitamin K antagonist [VKA]) not well suited to children. There is a clear need for a safe and effective, oral anticoagulant for the prevention of VTE in children at high risk for this significant complication.
The purpose of this study is to evaluate apixaban single-dose PK, PD, safety and tolerability in pediatric subjects at risk for venous or arterial thrombotic disorder. The primary objective is to assess the PK of a single dose of apixaban in pediatric subjects. The secondary objectives are to assess the single dose safety and tolerability of apixaban in pediatric subjects, and To assess the single dose anti-factor Xa activity in pediatric subjects.
Male and female pediatric subjects with or without a central venous catheter and at risk for a venous or arterial thrombotic disorder (neonates to < 18 years of age) as determined by medical history, physical examination, and clinical laboratory evaluations will be eligible to participate in the study
Additional Study Details:
We will recruit participants from the Penn State Milton S. Hershey Medical Center via physician or nurse referral.
Penn State Milton S. Hershey Medical Center
Pediatric Clinical Research Office