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This multi-center international research study assesses the effectiveness of the anti-clotting drug apixaban in the treatment pediatric patients with venous thromboembolism, a blood clot in a vein. The effects of the drug, which has been approved for adults, will be compared to the effects of standard drugs currently used by doctors to treat blood clots, including vitamin K antagonists, which inhibit the body from making proteins that produce blood clots, and low-molecular weight heparins and unfractionated heparin, which prevent the body from making blood clots.
While this study is designed for patients newborn through 17 years of age, it is currently enrolling participants from 3 months to 2 years old, who have a venous thromboembolism confirmed by imaging.
Males and Females: Ages 3 months to 2 years
Participants will be randomly assigned to take the study drug or standard therapy. The study drug will be dispensed in a weight-adjusted dose, to be taken orally twice a day during a 12-week study period. (Standard therapy may involve oral dosing or an injection.) Participants will need to visit the clinic for examinations, imaging and blood sampling.
Visits: 7 plus a follow up call or visit 35 days after end of treatment
Duration: About 17 weeks
Study Description at National Institutes of Health
Newborn Medicine Research
Thomas Diacovo, MD
For more information about the study or enrollment, please contact:
Dawn Thomas, CRN
Jessica Cagle, CRN
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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