Study Evaluating Betrixaban in Pediatric Participants
Condition: VTE Prophylaxis
Intervention: Betrixaban
Intervention description: Factor Xa inhibitor.
Intervention MeSH terms: Betrixaban
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This trial was a Phase 1, open-label, multicenter study of the pharmacokinetics (PK),
      pharmacodynamics (PD), and safety of a single dose of betrixaban in pediatric participants at
      risk of venous thromboembolism (VTE).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pediatric participants in the following age categories: 12 to < 18 years of age and 2
             to < 12 years of age. Part 1 of the study enrolled only adolescent participants 12 to
             < 18 years of age.

          2. Pediatric participant who was assessed to be at risk for VTE but did not require
             immediate anticoagulant therapy, for example:

               1. Had previous thrombosis and completed a course of anti-coagulant therapy, and is
                  considered to have a risk for recurrence of VTE, or

               2. Had any stable disease with a risk for arterial or venous thromboembolism, or

               3. Had any functional central venous access device in the upper or lower venous
                  system.

          3. Participant had normalized coagulation parameters (international normalized ratio or
             partial thromboplastin time, as appropriate) within 7 days of study drug
             administration.

        Exclusion Criteria:

        Participants who meet any one of the following exclusion criteria were excluded from the
        study:

          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).