A Randomized, Open-Label, Active Controlled, Safety and Descriptive Efficacy Study in Pediatric Subjects Requiring Anticoagulation for the Treatment of a Venous Thromboembolic Event
Clinical Trial Information
Trial Contact: Spinelli, Jennifer; Leffin, Melissa; El-Shami, Jessica; Cevallos, Claudia
- Primary: To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.
- Secondary: To evaluate apixaban PK and anti-FXa activity in pediatric subjects requiring anticoagulation for the treatment of a VTE.
1. 28 days to <18 years of age with a minimum weight of 4 kg at the time of randomization.
2. Presence of an index VTE which is confirmed by imaging.
3. Intention to manage the index VTE with anticoagulation treatment for at least 6 to 12 weeks.