Apixaban for the Acute Treatment of Venous Thromboembolism in Children
A Randomized, Open-Label, Active Controlled, Safety and Descriptive Efficacy Study in Pediatric Subjects Requiring Anticoagulation for the Treatment of a Venous Thromboembolic Event
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Clinical Trial Information
Trial Contact: Spinelli, Jennifer; Leffin, Melissa; El-Shami, Jessica
Trial Phone: 321.841.5357 ; 321.841.2008 ; 321.841.3837
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IRB No: 19.014.01
Protocol Abbrev: B0661037
Principal Investigator: Shveta Gupta, MD
Phase: Drug: Phase IV
Age Group: Pediatric
Secondary Protocol No: B0661037
Treatment: Drug: Apixaban Drug: Standard of Care
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT02464969
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Objective
- 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. -
Key Eligibility
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.
