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ED0157: Phase 1 Pediatric PK/PD Study

About this study

Edoxaban is an investigational medicine that may reduce blood clots, however, it is considered experimental because it is still being studied and has not yet been approved by the United States Food and Drug Administration (FDA).

Researchers want to understand more about how the body processes and responds to Edoxaban and they would like to measure that by examining blood samples provided by study participants. In this study all participants will receive a one-time dose of the medication, and they will be divided into groups according to age and how much or how little drug they receive. Each participant will be in the study for 2-4 weeks and will have up to 3 visits (screening, Check-In, Follow up) to the study clinic.

Eligibility criteria

  • Participant has a diagnosis requiring anticoagulant therapy.
  • Participant has completed their standard anticoagulant therapy.
  • Participant is not receiving active therapy for a malignant condition.
  • Participant is less than 18 years of age at the time of consent.
  • Participant and legal guardian agree to food and drug restrictions during study.

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Overview

Full title:

A Phase I, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics and Pharmacodynamics of Edoxaban in Pediatric Patients

Study goal:

To learn about the safety and effects of taking Edoxaban

Diagnosis:

For patients at risk for blood clots

Age:

Less than 18 years of age at the time of consent

Clinical trials categories:

Blood Disorders Hemophilia

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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