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7-day Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children From Birth to Less Than 6 Months With Arterial or Venous Thrombosis

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Trial Profile

7-day Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children From Birth to Less Than 6 Months With Arterial or Venous Thrombosis

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 29 Feb 2024

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At a glance

  • Drugs Rivaroxaban (Primary)
  • Indications Arterial thrombosis; Catheter thrombosis; Venous thromboembolism; Venous thrombosis
  • Focus Pharmacodynamics; Pharmacokinetics; Registrational
  • Acronyms EINSTEIN; Einstein Jr
  • Sponsors Bayer; Bayer HealthCare

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
  • 22 Jan 2021 According to a Bayer media release, the Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto) to treat VTE and prevent VTE recurrence in children, including catheter related thrombosis, cerebral vein and sinus thrombosis. The approval is based on data from a comprehensive clinical program, including the phase III EINSTEIN-Jr. study.
  • 13 Nov 2020 Results presented in a Bayer media release.

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