Status:
COMPLETED
Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
Lead Sponsor:
Daiichi Sankyo
Conditions:
Deep Vein Thrombosis
Venous Thromboembolism
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
Brief Summary
This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the b...
Detailed Description
Phase 1, open-label, multiple-center study in pediatric patients from 0 to \< 18 years of age. Patients will receive a single dose of edoxaban to match either the 30 mg (low dose) or the 60 mg (high d...
Eligibility Criteria
Inclusion
- Is a pediatric subject requiring anticoagulant therapy
- Will abstain from the use of nonsteroidal anti-inflammatory drugs (such as ibuprofen), and other antiplatelet and anticoagulant agents (except for aspirin) from 24 hours prior to edoxaban dose until after the last PK sample is collected
- Will follow food and concomitant medication restrictions
Exclusion
- Any major or clinically relevant unexplained bleeding during prior anticoagulant therapy
- History of abnormal bleeding or coagulation within last 6 months prior to study drug administration
- Renal function with glomerular filtration rate (GFR) less than 50% of normal for age and size
- Malabsorption disorders (e.g., cystic fibrosis or short bowel syndrome)
- Hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk, alanine transaminase (ALT) \> 5 times the upper limit of normal (ULN) or total bilirubin \> 2 times the ULN with direct bilirubin \> 20% of the total
Key Trial Info
Start Date :
November 5 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2021
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT02303431
Start Date
November 5 2014
End Date
September 16 2021
Last Update
October 11 2023
Active Locations (35)
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1
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90095
2
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
3
University of Colorado Denver
Denver, Colorado, United States, 80045
4
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611