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A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age After the Fontan Procedure

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Trial Profile

A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age After the Fontan Procedure

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2022

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At a glance

  • Drugs Rivaroxaban (Primary) ; Aspirin
  • Indications Thrombosis
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Registrational
  • Acronyms UNIVERSE
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 20 Dec 2021 According to a Janssen Pharmaceuticals media release, based on the EINSTEIN-Jr and UNIVERSE studies, the U.S. Food and Drug Administration (FDA) has approved two pediatric indications for XARELTO: the treatment of venous thromboembolism and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after initial parenteral anticoagulant treatment; and thromboprophylaxis in children aged 2 years and older with congenital heart disease who have undergone Fontan procecedure
    • 09 Dec 2021 New source identified and integrated (Japan Pharmaceutical Information Center - Clinical Trials Information record: JapicCTI183942).
    • 27 Sep 2021 Results presented in a Bayer Media Release.

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