Dabigatran Etexilate in Children with Venous Thromboembolism: Results of the Open-Label, Phase IIb/III, Randomized Diversity Clinical Trial

Background: In children, current standard of care (SOC) with heparins or vitamin K antagonists is limited by the need for parenteral administration and frequent monitoring. Dabigatran etexilate (DE), a direct oral anticoagulant, is an effective oral treatment for venous thromboembolism (VTE) in adults and may be an effective and safe alternative to SOC for treating acute VTE in children. Aims: The DIVERSITY trial evaluated the efficacy and safety of DE versus SOC, and the appropriateness of a DE dosing algorithm, in children with VTE aged from birth to Methods: This was an open-label, randomized, active-controlled, multicenter, phase IIb/III trial (NCT01895777; consent obtained and ethics committee approved). Children (12 to Results: Of 267 children in the randomized set, 35 were aged Conclusions: This randomized trial confirmed that an age- and weight-adjusted dabigatran dosing algorithm was appropriate in children aged from birth to Download : Download high-res image (329KB) Download : Download full-size image Disclosures Halton: Boehringer Ingelheim: Other: Member of a paediatric expert working group. Brandao: Boehringer Ingelheim: Other: Member of a paediatric expert working group. Luciani: Boehringer Ingelheim: Other: Member of a paediatric expert working group. Bomgaars: Boehringer Ingelheim: Other: Member of a paediatric expert working group. Chalmers: Shire/Takeda: Honoraria; CSL Behring: Honoraria; Bristol-Myers Squibb: Honoraria; Sobi: Honoraria; Roche: Honoraria; Grifols: Honoraria; Boehringer Ingelheim: Other: Member of a paediatric expert working group. Mitchell: Boehringer Ingelheim: Other: Member of a paediatric expert working group. Sharathkumar: Takeda: Consultancy; CSL Behring: Consultancy; Bayer: Consultancy; Kedrion: Consultancy. Svirin: Takeda: Consultancy, Other: Personal fees; CSL Behring: Consultancy, Other: Personal fees. Tartakovsky: Boehringer Ingelheim: Current Employment. Simetzberger: Boehringer Ingelheim: Current Employment. Huang: Boehringer Ingelheim: Current Employment. Sun: Boehringer Ingelheim: Current Employment. Kreuzer: Boehringer Ingelheim: Current Employment. Gropper: Boehringer Ingelheim: Current Employment. Brueckmann: Boehringer Ingelheim: Current Employment. Albisetti: Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees; Boehringer Ingelheim: Other: Member of a paediatric expert working group. OffLabel Disclosure: dabigatran etexilate in paediatric VTE