Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies

Publication date: Available online 13 August 2019Source: The Lancet HaematologyAuthor(s): Paul Monagle, Anthonie W A Lensing, Kirstin Thelen, Ida Martinelli, Christoph Male, Amparo Santamaría, Elena Samochatova, Riten Kumar, Susanne Holzhauer, Paola Saracco, Paolo Simioni, Jeremy Robertson, Gernot Grangl, Jacqueline Halton, Phillip Connor, Guy Young, Angelo C Molinari, Ulrike Nowak-Göttl, Gili Kenet, Stefanie KapsaSummaryBackgroundRivaroxaban has been shown to be efficacious for treatment of venous thromboembolism in adults, and has a reduced risk of bleeding compared with standard anticoagulants. We aimed to develop paediatric rivaroxaban regimens for the treatment of venous thromboembolism in children and adolescents.MethodsIn this phase 2 programme, we did three studies to evaluate rivaroxaban treatment in children younger than 6 months, aged 6 months to 5 years, and aged 6–17 years. Our studies used a multicentre, single-arm design at 54 sites in Australia, Europe, Israel, Japan, and north America. We included children with objectively confirmed venous thromboembolism previously treated with low-molecular weight heparin, fondaparinux, or a vitamin K antagonist for at least 2 months or, in children who had catheter-related venous thromboembolism for at least 6 weeks. We administered rivaroxaban orally in a bodyweight-adjusted 20 mg-equivalent dose, based on physiologically-based pharmacokinetic modelling predictions and EINSTEIN-Jr phase 1 data in young adults, in eith...
Source: The Lancet Haematology - Category: Hematology Source Type: research