Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism

Trial Profile

Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Mar 2022

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Rivaroxaban (Primary) ; Dalteparin sodium; Enoxaparin sodium; Fondaparinux sodium; Tinzaparin sodium; Warfarin
  • Indications Venous thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms EINSTEIN Junior Phase III
  • Sponsors Bayer; Bayer HealthCare; Janssen Research & Development
  • Most Recent Events

    • 01 Mar 2022 Results of sub-group analysis assessing risk of bleeding and recurrent thrombosis, and perioperative anticoagulant management of children with cerebral venous thrombosis (CVT) and an associated head or neck infection, published in the Pediatric Neurology.
    • 22 Dec 2021 According to a Bayer media release, based on data from EINSTEIN DVT, PE and EXTENSION, EINSTEIN-Jr., and UNIVERSE, the U.S. FDA has approved two pediatric indications for Xarelto: the treatment of VTE and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis in children aged two years and older with congenital heart disease who have undergone the Fontan procedure.
    • 23 Jun 2021 According to a Janssen media release, The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top