Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
Deep Vein Thrombosis, Venous Thromboembolism
About this trial
This is an interventional basic science trial for Deep Vein Thrombosis focused on measuring Pediatric, Pharmacokinetics (PK), Pharmacodynamics (PDy), Anticoagulant, Safety
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of California, Los Angeles (UCLA)
- Lucile Packard Children's Hospital Stanford University
- University of Colorado Denver
- Ann and Robert H. Lurie Children's Hospital of Chicago
- Indiana Hemophilia and Thrombosis Center
- University of Louisville ; Kosair Charities Pediatric Clincial Research Unit
- Duke University Medical Center (DUMC)
- University Hospitals Case Medical Center - Rainbow Babies and Children's Hospital
- The Children's Hospital of Philadelphia
- Hasbro Children's Hospital
- St. Jude Children's Research Hospital, Inc.
- Children's Hospital of Wisconsin
- McMaster Children's Hospital
- Childrens Hospital of Eastern Ontario
- Hopital Arnaud de Villeneuve
- CHU Bordeaux - Hopital Haut-Leveque
- Nirmal Hospital Pvt. Ltd
- Institute of Child Health
- Christian Medical College and Hospital
- Istituto Giannina Gaslini - UOSD Emostasi e Trombosi
- A O Universita degli Studi di Padova ; Dipartimento di Salute della Donna e del Bambino-Universita di Padova
- Bambino Gesu Hospital
- Hotel Dieu De France
- Hammoud Hospital University Medical Center
- Hospital Universitario Vall d'Hebron
- Hospital Universitario Reina Sofia
- Hospital Clinico San Carlos
- Hospital Universitario La Paz
- Hospital Universitario Araba
- Ege University Medical Faculty - Department of Pediatric Hematology
- Leeds General Infirmary
- Glenfield Hospital
- Guy's and St Thomas Hospital NHS Trust
- Royal Brompton Hospital
- Southampton General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1a
Cohort 1b
Cohort 2a
Cohort 2b
Cohort 3a
Cohort 3b
Cohort 4a
Cohort 4b
Cohort 5a
Cohort 5b
12 to < 18 years of age: edoxaban low dose group
12 to < 18 years of age: edoxaban high dose group
6 to < 12 years of age: edoxaban low dose group
6 to < 12 years of age: edoxaban high dose group
2 to < 6 years of age: edoxaban low dose group
2 to < 6 years of age: edoxaban high dose group
6 months to <2 years of age: edoxaban low dose group
6 months to <2 years of age: edoxaban high dose group
0 to 6 months of age: edoxaban low dose group
0 to 6 months: edoxaban high dose group