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Apixiban for Pediatric Venous Thromboembolic Event (VTE) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the safety of apixiban when compared to other blood thinner medicines used to treat VTE.   

What is the Condition Being Studied?

Venous Thromboembolism (VTE) (blood clots) in children

Who Can Participate in the Study?

To be in this study, your child must:
- Be a newborn to 17 years old.
- Have a confirmed VTE (blood clot) with imaging (CT scan, MRI, or ultrasound)
- Manage the VTE with blood thinner medicine for at least 12 weeks (at least 6 weeks for neonates)
- Not have a mechanical heart valve, active bleeding or considered high risk of bleeding
- Not be allergic to apixiban 

Age Group
Children

What is Involved?

If you choose to have your child join this study, your child will:
- Be randomized (like drawing names from a hat) to one of two treatments:
-- Apixiban (the study drug)
-- Standard treatment with anticoagulants (blood thinners)
- Have blood tests
- Have imaging tests (for example, ultrasound, CT scans, MRIs) to confirm condition, around the middle of the treatment and at the end of treatment.  
- Note: you will know which treatment your child is receiving

Study Details

Full Title
A Randomized, Open-Label, Active, Controlled Safety and Descriptive Efficacy Study in Pediatric Subjects Requiring Anticoagulation for the Treatment of a Venous Thromboembolic Event
Principal Investigator
Pediatric Hematology-Oncology Specialist
Protocol Number
IRB:PRO00060499
NCT:NCT02464969
Phase
Phase IV
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698