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EDO312: Edoxaban, a new Oral Anticoagulant, for Blood Clots in Children

About this study

Edoxaban is an investigational medicine that may reduce blood clots. It is considered an experimental drug because it is still being studied. It has been approved by the United States Food and Drug Administration (FDA) for use in adults but not for use in children.

A blood clot is blood that becomes a solid instead of a liquid. When a blood clot occurs in a vein, it is known as venous thromboembolism.

Several drugs are currently used to treat blood clots in children.  These are called “Standard of Care.” This study will compare edoxaban to currently available drugs to see which one works better. Study participants will be randomly placed in one of two groups.  You will have a 50/50 chance (like flipping a coin) to get in the edoxaban group or the Standard of Care group.

Children in one group will be given the study medicine, while children in the other group will be given the drug that is currently being used to treat blood clots. You will know which drug you are going to receive.  At the end of the study, researchers will compare which of the two treatments has the best results.

Eligibility overview

  • Newborn to 17 years old (must be younger than 18)
  • Diagnosis of blood clot (venous thromboembolism, also called VTE)
  • Requires anticoagulant therapy for at least 90 days
  • Received at least 5 days of heparin therapy prior to study

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Overview

Full title:

A Phase 3, Open-label, Randomized, Multi-center, Controlled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed Venous Thromboembolism (VTE)

Study goal:

The main goal of this study is to see if edoxaban is safe to use in children and how well it treats blood clots in children, compared to currently available medicines.

Diagnosis:

Blood clots (venous thromboembolism)

Age:

Newborn to 17 years old (must be younger than 18)

Clinical trials categories:

Blood Disorders

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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