Status:
TERMINATED
Study Evaluating Betrixaban in Pediatric Participants
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Collaborating Sponsors:
Portola Pharmaceuticals, LLC (a wholly owned subsidiary of Alexion Pharmaceuticals)
Conditions:
VTE Prophylaxis
Eligibility:
All Genders
2-17 years
Phase:
PHASE1
Brief 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 throm...
Detailed Description
This study was to be conducted in 2 parts: Part 1 and Part 2. Part 1 (the initial opening of the study) was conducted in 21 adolescent participants (12 to \< 18 years of age) who were assessed to be a...
Eligibility Criteria
Inclusion
- 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.
- Pediatric participant who was assessed to be at risk for VTE but did not require immediate anticoagulant therapy, for example:
- Had previous thrombosis and completed a course of anti-coagulant therapy, and is considered to have a risk for recurrence of VTE, or
- Had any stable disease with a risk for arterial or venous thromboembolism, or
- Had any functional central venous access device in the upper or lower venous system.
- Participant had normalized coagulation parameters (international normalized ratio or partial thromboplastin time, as appropriate) within 7 days of study drug administration.
Exclusion
- Participants who meet any one of the following exclusion criteria were excluded from the study:
- Participant received any dose of anti-coagulant therapy within 7 days of Day 1.
- Participant had active bleeding or had a comorbid disorder that placed the participant at high risk for bleeding.
- Participant had a comorbid disorder that placed the participant at risk of death within 90 days of enrollment.
- Participant had abnormal coagulation tests at baseline.
- Participant had recent or planned invasive procedures, including lumbar puncture and removal of non-peripherally placed central lines during study.
- 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.
- Participant had known congenital or acquired bleeding diathesis.
- Participant required concomitant therapy with a strong P-glycoprotein inhibitor.
- Participant had previous history of any non-traumatic bleeding event that was life threatening or required medical attention.
- Participant had been administered thrombolytic therapy, or had undergone thrombectomy, or insertion of a caval filter to treat prior VTE.
- Participant had known inherited or acquired bleeding diathesis or coagulopathy.
- Participant had abnormal QTcF interval on baseline electrocardiogram.
- Participant received a dose of any antiplatelet medication (including aspirin) within 14 days before study drug dosing.
- Participant had malabsorption disorders (for example, cystic fibrosis or short bowel syndrome).
- Participant had an estimated glomerular filtration rate \< 30 milliliters/minute.
- Participant was unable or reluctant to cooperate with the study procedures.
- Participant had hypersensitivity to other Factor Xa inhibitors, or the components of the dosage form.
- Participant had participated in a study with an investigational drug or medical device within 30 days prior to administration of betrixaban.
- Participant was female and of childbearing potential and was either pregnant or breastfeeding a child.
- Participant was sexually active and was not using medically accepted contraceptive method (if applicable).
Key Trial Info
Start Date :
July 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03346083
Start Date
July 13 2018
End Date
October 8 2019
Last Update
January 12 2024
Active Locations (20)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
ACTCA, Axis Clinical Trials
Los Angeles, California, United States, 90036
3
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
4
Tulane Medical Center
New Orleans, Louisiana, United States, 70001