The Edoxaban Hokusai VTE PEDIATRICS Study: An open-label, multicenter, randomized study of edoxaban for pediatric venous thromboembolic disease.

ABSTRACT:

Background

Little evidence is available for treatment of pediatric venous thromboembolism (VTE). Large randomized controlled trials are challenging in children. Current antithrombotic agents have many limitations, including nonoral administration and frequent monitoring. Edoxaban is an oral direct inhibitor of factor Xa without need of monitoring. In adults with VTE, edoxaban has shown to be effective and safe.

Objectives

The Edoxaban Hokusai VTE PEDIATRICS Study is an open-label, randomized clinical trial to evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and whether edoxaban is noninferior to standard of care in treatment of pediatric VTE.

Methods

A goal of 274 patients will be recruited in 5 age categories. A multidose PK/PD assessment on day 5

SUBMITTER: van Ommen CH 

PROVIDER: S-EPMC7354398 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature