Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein‐Jr phase 3 dose‐exposure‐response evaluation

G Young, AWA Lensing, P Monagle… - … of Thrombosis and …, 2020 - Wiley Online Library
Background Recently, the randomized EINSTEIN‐Jr study showed similar efficacy and
safety for rivaroxaban and standard anticoagulation for treatment of pediatric venous …

Rivaroxaban versus standard anticoagulation for acute venous thromboembolism in childhood. Design of the EINSTEIN-Jr phase III study

AWA Lensing, C Male, G Young, D Kubitza, G Kenet… - Thrombosis journal, 2018 - Springer
Background Venous thromboembolism (VTE) is a relatively rare condition in childhood with
treatment mainly based on extrapolation from studies in adults. Therefore, clinical trials of …

Exploratory evaluation of pharmacodynamics, pharmacokinetics and safety of rivaroxaban in children and adolescents: an EINSTEIN-Jr phase I study

D Kubitza, S Willmann, M Becka, K Thelen, G Young… - Thrombosis …, 2018 - Springer
Abstract Background The EINSTEIN-Jr program will evaluate rivaroxaban for the treatment
of venous thromboembolism (VTE) in children, targeting exposures similar to the 20 mg …

Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies

P Monagle, AWA Lensing, K Thelen… - The Lancet …, 2019 - thelancet.com
Background Rivaroxaban has been shown to be efficacious for treatment of venous
thromboembolism in adults, and has a reduced risk of bleeding compared with standard …

Pharmacokinetics of rivaroxaban in children using physiologically based and population pharmacokinetic modelling: an EINSTEIN-Jr phase I study

S Willmann, K Thelen, D Kubitza, AWA Lensing… - Thrombosis …, 2018 - Springer
Abstract Background The EINSTEIN-Jr program will evaluate rivaroxaban for the treatment
of venous thromboembolism (VTE) in children, targeting exposures similar to the 20 mg …

Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial

C Male, AWA Lensing, JS Palumbo, R Kumar… - The Lancet …, 2020 - thelancet.com
Background Treatment of venous thromboembolism in children is based on data obtained in
adults with little direct documentation of its efficacy and safety in children. The aim of our …

Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban

S Willmann, C Becker, R Burghaus, K Coboeken… - Clinical …, 2014 - Springer
Background Venous thromboembolism has been increasingly recognised as a clinical
problem in the paediatric population. Guideline recommendations for antithrombotic therapy …

The in vitro anticoagulant effect of rivaroxaban in children

C Attard, P Monagle, D Kubitza, V Ignjatovic - Thrombosis research, 2012 - Elsevier
INTRODUCTION: Current anticoagulation therapy in children is less than ideal, requiring
regular venous monitoring and dosing adjustments. Limitations associated with …

The in-vitro anticoagulant effect of rivaroxaban in neonates

C Attard, P Monagle, D Kubitza… - Blood Coagulation & …, 2014 - journals.lww.com
The use of anticoagulants in neonates is increasing because of the medical advances
improving the long-term survival of very sick infants who are at risk of venous …

Efficacy and safety of non-vitamin K antagonist oral anticoagulants in pediatric venous thromboembolism treatment and thromboprophylaxis: a systematic review of the …

JW Branstetter, AL Kiskaddon, MA King… - … in Thrombosis and …, 2021 - thieme-connect.com
Venous thromboembolism (VTE) in children can lead to significant morbidity and mortality.
Traditionally, treatment for thrombotic events in pediatric patients has been limited mainly to …