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Exploratory evaluation of pharmacodynamics,...
Journal article

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

Abstract

BackgroundThe EINSTEIN-Jr program will evaluate rivaroxaban for the treatment of venous thromboembolism (VTE) in children, targeting exposures similar to the 20 mg once-daily dose for adults.MethodsThis was a multinational, single-dose, open-label, phase I study to describe the pharmacodynamics (PD), pharmacokinetics (PK) and safety of a single bodyweight-adjusted rivaroxaban dose in children aged 0.5–18 years. Children who had completed …

Authors

Kubitza D; Willmann S; Becka M; Thelen K; Young G; Brandão LR; Monagle P; Male C; Chan A; Kennet G

Journal

Thrombosis Journal, Vol. 16, No. 1,

Publisher

Springer Nature

Publication Date

12 2018

DOI

10.1186/s12959-018-0186-0

ISSN

1477-9560