Study Evaluating Betrixaban in Pediatric Participants

Exclusion Criteria

• •1. Participant received any dose of anti-coagulant therapy within 7 days of Day 1.
• •2. Participant had active bleeding or had a comorbid disorder that placed the participant at high risk for bleeding.
• •3. Participant had a comorbid disorder that placed the participant at risk of death within 90 days of enrollment.
• •4. Participant had abnormal coagulation tests at baseline.
• •5. Participant had recent or planned invasive procedures, including lumbar puncture and removal of non-peripherally placed central lines during study.
• •6. Participant had hepatic disease associated with one or more of the following:
• •* Transaminase levels ≥ 2.5 × upper limit of normal (ULN) or bilirubin ≥ 1.5 × ULN at baseline.
• •* Coagulopathy leading to a clinically relevant bleeding risk, or hepatic transaminase level of \> 2 × ULN or total bilirubin \> 2 × ULN with direct bilirubin \> 20% of the total.
• •* Platelet count \< 75 × 10\^9/liter or hemoglobin \< 10.0 mg/deciliter.
• •* Hypertension.
• •7. Participant had known congenital or acquired bleeding diathesis.
• •8. Participant required concomitant therapy with a strong P-glycoprotein inhibitor.
• •9. Participant had previous history of any non-traumatic bleeding event that was life threatening or required medical attention.
• •10. Participant had been administered thrombolytic therapy, or had undergone thrombectomy, or insertion of a caval filter to treat prior VTE.
• •11. Participant had known inherited or acquired bleeding diathesis or coagulopathy.
• •12. Participant had abnormal QTcF interval on baseline electrocardiogram.
• •13. Participant received a dose of any antiplatelet medication (including aspirin) within 14 days before study drug dosing.
• •14. Participant had malabsorption disorders (for example, cystic fibrosis or short bowel syndrome).
• •15. Participant had an estimated glomerular filtration rate \< 30 milliliters/minute.
• •16. Participant was unable or reluctant to cooperate with the study procedures.
• •17. Participant had hypersensitivity to other Factor Xa inhibitors, or the components of the dosage form.
• •18. Participant had participated in a study with an investigational drug or medical device within 30 days prior to administration of betrixaban.
• •19. Participant was female and of childbearing potential and was either pregnant or breastfeeding a child.
• •20. Participant was sexually active and was not using medically accepted contraceptive method (if applicable).