Dosing Regimen Prediction and Confirmation With Rivaroxaban for Thromboprophylaxis in Children After the Fontan Procedure: Insights From the Phase III UNIVERSE Study

Dosing Regimen Prediction and Confirmation With Rivaroxaban for Thromboprophylaxis in Children After the Fontan Procedure: Insights From the Phase III UNIVERSE Study

Thrombosis remains an important complication for children with single-ventricle physiology following the Fontan procedure, and effective thromboprophylaxis is an important unmet medical need. To obviate conventional dose-finding studies and expedite clinical development, a rivaroxaban dose regimen f...

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Bibliographic Details
Main Authors:	Harris, K.C (Author), Kubitza, D. (Author), Lesko, L.J (Author), Li, J.S (Author), McCrindle, B.W (Author), Michelson, A.D (Author), Nessel, K. (Author), Pina, L.M (Author), Weber, T. (Author), Willmann, S. (Author), Yang, H. (Author), Zannikos, P. (Author), Zhou, W. (Author), Zhu, P. (Author)
Format:	Article
Language:	English
Published:	John Wiley and Sons Inc 2022
Subjects:	acetylsalicylic acid activated partial thromboplastin time adult anticoagulant agent Anticoagulants Area Under Curve area under the curve Article biological model blood clotting factor 10a inhibitor body weight Body Weights and Measures child Child Child, Preschool clinical trial controlled study drug dose regimen drug efficacy drug safety drug tolerability female Female Fontan procedure Fontan Procedure groups by age heart single ventricle heparin human Humans low molecular weight heparin major clinical study male Male maximum plasma concentration Models, Biological morphometry multicenter study open study partial thromboplastin time Partial Thromboplastin Time pharmacokinetic parameters phase 3 clinical trial plasma concentration-time curve postoperative thrombosis prediction preschool child procedures Prospective Studies prospective study prothrombin time Prothrombin Time quantitative analysis randomized controlled trial rivaroxaban Rivaroxaban school child thrombosis Thrombosis thrombosis prevention trough concentration
Online Access:	View Fulltext in Publisher

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