EINSTEIN-Jr clinical trials of Rivaroxaban in children
EINSTEIN-Jr clinical trials of Rivaroxaban in children
Rivaroxaban is useful for treatment of venous thromboembolism in adults and is associated with lower risk of bleeding compared to standard anticoagulants. EINSTEIN-Jr phase 2 used bodyweight adjusted rivaroxaban for children with venous thromboembolism [1]. It was a single arm multicenter study three age groups – children younger than 6 months, those in age group 6 months to 5 years and in children and adolescents between 6-17 years. Studies were done at 54 sites across Australia, Europe, Israel, Japan and North America. The study was in children with confirmed venous thromboembolism who have been treated for at least 2 months low molecular weight heparin, fondaparinux or vitamin K antagonist. In children with catheter related venous thromboembolism the cut off for previous treatment was 6 weeks. 89 children (96%) completed study treatment. None of the children had major bleed. 4% had clinically relevant non-major bleed. There was no symptomatic recurrent venous thromboembolism. In 75 patients repeat imaging showed resolution of thrombus burden. 43 had improved and 8 were unchanged. No patient deteriorated in this study.
EINSTEIN-Jr phase 3 was a multicenter, open label randomized study in children and adolescents up to the age of 17 years [2]. The study was conducted across 107 pediatric hospitals in 28 countries. Children with acute venous thromboembolism on heparin were assigned to either body weight adjusted riv...
Source: Cardiophile MD - Category: Cardiology Authors: Prof. Dr. Johnson Francis Tags: General Cardiology Source Type: blogs
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