A RANDOMIZED OPEN-LABEL ACTIVE CONTROLLED SAFETY AND EXTRAPOLATED EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT
Kerry Hege, MD
Primary Investigator
Brief description of study
The purpose of this research study is to assess the safety and efficacy of apixaban (which is a new anti-clotting drug) in the treatment of these blood clots in children.
Detailed description of study
The purpose of this study is to assess the safety and efficacy of apixaban in the treatment of these blood clots in children.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: blood clot, Riley
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Age: 12 years - 18 years
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Gender: All
Inclusion Criteria
Presence of an index VTE which is confirmed by imaging
Intention to manage the index VTE with anticoagulation treatment for at least 12 weeks or intention to manage the index VTE with anticoagulation treat in neonates for at least 6 weeks
Exclusion Criteria
Anticoagulant treatment for the index VTE for greater than 7 days prior to randomization
Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE
A mechanical heart valve
Active bleeding or high risk of bleeding at the time of randomization
Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization
Abnormal baseline liver function or conjugated bilirubin at randomization
At the time of randomization, inadequate renal function
At the time of randomization, uncontrolled severe hypertension
At the time of randomization, use of prohibited concomitant medication
Known allergy to apixaban
Female subject who are either pregnant or breastfeeding a child
Geographically unavailable for follow-up
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