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...

Full description

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

Internet

View Fulltext in Publisher

Similar Items