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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

  • Clinical Trial Information

    Trial Contact: Spinelli, Jennifer; Leffin, Melissa; El-Shami, Jessica; Cevallos, Claudia

  • 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

  • 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.