A phase 1, open-label, single dose, non-randomized study to evaluate pharmacokinetics, pharmacodynamics, and safety of Betrixaban in pediatric patients. - Protocol 16-021 – Pediatric PK

Portola Pharma UK Ltd0 sites33 target enrollmentOctober 31, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pediatric patients who are assessed to be at risk for Venous thromboembolism (VTE) but does not require immediate anticoagulant therapy, for example:a. Has previous thrombosis and completed a course of anti-coagulant therapy, and is considered to have a risk for recurrence of VTE, orb. Has any stable disease with a risk for arterial or venous thrombotic disorder, orc. Has any functional CVAD (Central Venous Access Device) in the upper or lower venous system.
Sponsor: Portola Pharma UK Ltd
Enrollment: 33
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

October 31, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Portola Pharma UK Ltd

•1\. Pediatric patients in the following age categories: 12 to \< 18 years of age and 2 to \< 12 years of age. Part 1 of the study will enroll only adolescent patients 12 to \< 18 years of age.
•2\. Patient is a pediatric subject who is assessed to be at risk for VTE but does not require immediate anticoagulant therapy, for example:
•a. Has previous thrombosis and completed a course of anti\-coagulant therapy, and is considered to have a risk for recurrence of VTE, or
•b. Has any stable disease with a risk for arterial or venous thrombotic disorder, or
•c. Has any functional CVAD (Central Venous Access Device) in the upper or lower venous system.
•3\. Patient must be able to have regular intake of a small amount of food (e.g., \= 100 mL) and eat before taking study medication, when instructed.
•4\. Patient has normalized coagulation parameters (INR or PTT, as appropriate) within 7 days of study drug administration.
•5\. Patient is sexually abstinent or, if not sexually abstinent, agrees to use an approved method of contraception (if applicable).
•6\. Patient has adequate venous access to allow for blood sampling.
•7\. Patient has provided Assent and responsible parent or guardian has signed Informed Consent.

•1\. Patient received any dose of anticoagulant therapy within 7 days of Day 1\.
•2\. Patient has active bleeding or has a comorbid disorder that places the patient at high risk for bleeding, including a positive fecal occult blood test or hematuria within 30 days prior to Day \-1\.
•3\. Patient has a comorbid disorder that places the patient at risk of death within 90 days of enrollment.
•4\. Patient has abnormal coagulation tests at baseline (within 3 days of Day \-1\).
•5\. Patient has had recent or planned invasive procedures, including lumbar puncture and removal of non\-peripherally placed central lines during study.
•6\. Patient has 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 × 109/L or hemoglobin \< 10\.0 mg/dL.
•? Hypertension.