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
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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.