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
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
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.Summary of Results
This is a single dose study in patients from birth to < 18 years of age. The main reason for this study was to see how the drug edoxaban is absorbed, metabolized and excreted within the body. The study was designed to allow for selection of a dose which provided the same type of results as seen in adults and to determine a recommended oral dose for longer term use in children.Edoxaban was absorbed rapidly after being given by mouth in low dose or high dose to all ages of children. The results in all cohorts (groups including children of similar age) were found to look like the results in adults with 90% accuracy, except for 1 child less than 6 months old who had no side effects from the drug.
The drug achieved a peak amount within the body between 1.5 to 3 hours after taking it and then rapidly cleared from the body between 4 to 8 hours. Important across all ages of children; the drug effect was 0.5 to 1.5 times the results seen in adults. This is not uncommon in children. Edoxaban was safe and well tolerated. Some patients experienced side effects which were mild in nature which eventually went away and did not require medication or further treatment by a Doctor.
In children less than 18 years old, Edoxaban was absorbed quickly when taken orally and had the same amount of drug within the colorless fluid part of blood (plasma) over time. No serious side effects were experienced by any children.
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