Study Evaluating Betrixaban in Pediatric Participants

Stopped early · Phase 1

Conditions studied: VTE Prophylaxis

In brief

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).

Key facts

Study ID

NCT03346083

Run by

Alexion Pharmaceuticals, Inc.

People needed

21

Starts

2018-07-13

Expected to finish

2019-10-08

Last updated by the study team

2024-01-12

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• ACTCA, Axis Clinical Trials — Los Angeles, California, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States
• Children's Hospital of Tatarstan Republic — Kazan', Russia
• Federal State Institution — Kemerovo, Russia
• Children's City Clinical Hospital — Moscow, Russia
• Pirogov Russian National Research Medical University — Moscow, Russia
• State Budgetary Institution — Nizhny Novgorod, Russia
• Saint Petersburg State Pediatric Medical University — Saint Petersburg, Russia
• Ivano-Frankivsk Regional Children Clinical Hospital — Ivano-Frankivsk, Ukraine
• Odessa Regional Children Clinical Hospital — Odesa, Ukraine
• Sumy Regional Children's Hospital — Sumy, Ukraine
• Vinnytsia Regional Children's Clinical Hospital, Department of Anesthesiology and Intensive Care — Vinnitsa, Ukraine
• Birmingham Women's and Children's NHS Foundation Trust — Birmingham, United Kingdom
• Addenbrooke's Hospital — Cambridge, United Kingdom
• Children's Hospital for Wales — Cardiff, United Kingdom
• Glenfield Hospital — Leicester, United Kingdom
• Evelina London Children's Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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