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Edoxaban - Paediatric

  • Research type

    Research Study

  • Full title

    A Phase 1, Open-label, Single-dose, Non-randomized Study to Evaluate Pharmacokinetics (PK) and Pharmacodynamics (PD) of Edoxaban in Paediatric Patients

  • IRAS ID

    200445

  • Contact name

    Piers Daubeney

  • Contact email

    P.Daubeney@rbht.nhs.uk

  • Sponsor organisation

    Daiichi Sankyo , Inc.

  • Eudract number

    2015-005732-18

  • Clinicaltrials.gov Identifier

    77,254 and 63,266, IND Number

  • Duration of Study in the UK

    1 years, 8 months, 1 days

  • Research summary

    Anticoagulation therapy is a type of medicine that helps to prevent the blood from clotting and reduce the chances of conditions such as strokes and heart attacks. Most patients that require such therapy suffer from deep vein thrombosis (blood clot within a vein), atrial fibrillation (abnormal heart rhythm), congenital heart disease, or other cardiac conditions. The most commonly prescribed anticoagulant in UK is warfarin.
    Edoxaban is an anticoagulant which is already approved in US and EU for use in adults for preventing stroke and systemic embolism (obstruction of artery) in people with non-valvular atrial fibrillation (abnormal heart rhythm).
    This study is being done to evaluate Edoxaban effects on children. Daiichi Sankyo Pharma Development aims to generate information that will allow dose selection of Edoxaban for subsequent clinical studies.
    This is a multicentre study which will take place in North America, Europe, and other regions if needed. It is anticipated that 48 patients aged 0 to <18 years old will be enrolled, 12 patients in each age cohort (6 patients in each dose group).
    This is an open-label, single-dose, non-randomized study meaning that all participants will receive one oral dose of Edoxaban (15 or 30 mg) and both the participant and the study staff know the drug and dosage that is being taken. Patients will be divided in to 4 age cohorts (12 to <18, 6 to <12, 2 to <6 and 0 to <2 years of age) with a low and high dose group in each cohort.

  • REC name

    West of Scotland REC 1

  • REC reference

    16/WS/0114

  • Date of REC Opinion

    5 Jul 2016

  • REC opinion

    Further Information Favourable Opinion