Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study

Completed · Phase 1

Conditions studied: Deep Vein Thrombosis, Venous Thromboembolism

In brief

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 body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics), and to compare if these effects are similar to those observed in adults.

Key facts

Study ID

NCT02303431

Run by

Daiichi Sankyo

People needed

66

Starts

2014-11-05

Expected to finish

2021-09-16

Last updated by the study team

2023-10-11

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Los Angeles (UCLA) — Los Angeles, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• University of Colorado Denver — Denver, Colorado, United States
• Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Indiana Hemophilia and Thrombosis Center — Indianapolis, Indiana, United States
• University of Louisville ; Kosair Charities Pediatric Clincial Research Unit — Louisville, Kentucky, United States
• Duke University Medical Center (DUMC) — Durham, North Carolina, United States
• University Hospitals Case Medical Center - Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Hasbro Children's Hospital — Providence, Rhode Island, United States
• St. Jude Children's Research Hospital, Inc. — Memphis, Tennessee, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• McMaster Children's Hospital — Hamilton, Ontario, Canada
• Childrens Hospital of Eastern Ontario — Ottawa, Canada
• Hopital Arnaud de Villeneuve — Montpellier, France
• CHU Bordeaux - Hopital Haut-Leveque — Pessac, France
• Nirmal Hospital Pvt. Ltd — Gujrāt, India
• Institute of Child Health — Kolkata, India
• Christian Medical College and Hospital — Ludhiāna, India
• Istituto Giannina Gaslini - UOSD Emostasi e Trombosi — Genova, Italy
• A O Universita degli Studi di Padova ; Dipartimento di Salute della Donna e del Bambino-Universita di Padova — Padova, Italy
• Bambino Gesu Hospital — Rome, Italy
• Hotel Dieu De France — Beirut, Lebanon
• Hammoud Hospital University Medical Center — Saida, Lebanon
• Hospital Universitario Vall d'Hebron — Barcelona, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.