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Betrixaban

DRUG8 trials

Sponsors

Portola Pharmaceuticals, Alexion Pharmaceuticals, Inc.

Conditions

Atrial FibrillationHealthyHealthy SubjectsHepatic ImpairmentRenal ImpairmentThromboembolismVTE ProphylaxisVenous Thromboembolism (VTE)

Phase 1

A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment
CompletedNCT00999336
Portola PharmaceuticalsRenal Impairment
Start: 2009-07-31End: 2010-02-28Updated: 2023-08-22
A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers
CompletedNCT01765868
Portola PharmaceuticalsHealthy Subjects
Start: 2007-09-30End: 2007-10-31Updated: 2023-08-08
A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations
CompletedNCT02596100
Portola PharmaceuticalsHealthy
Start: 2015-09-30End: 2015-11-30Updated: 2023-08-08
Study Evaluating Betrixaban in Pediatric Participants
TerminatedNCT03346083
Alexion Pharmaceuticals, Inc.VTE Prophylaxis
Start: 2018-07-13End: 2019-10-08Updated: 2024-01-12
The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist
CompletedNCT03397888
Portola PharmaceuticalsHepatic Impairment
Start: 2017-11-16End: 2018-01-16Updated: 2023-02-21

Phase 2

Factor Xa Inhibitor, PRT054021, Against Enoxaparin for the Prevention of Venous Thromboembolic Events (EXPERT)
CompletedNCT00375609
Portola PharmaceuticalsThromboembolism
Start: 2006-05-31End: 2007-02-28Updated: 2023-08-07
Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin
CompletedNCT00742859
Portola PharmaceuticalsAtrial Fibrillation
Start: 2008-10-31End: 2009-11-30Updated: 2023-08-07

Phase 3

Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)
CompletedNCT01583218
Portola PharmaceuticalsVenous Thromboembolism (VTE)
Start: 2012-03-31End: 2016-01-31Updated: 2023-08-07

Related Papers

External validation of the ADA score for predicting thrombosis among acutely ill hospitalized medical patients from the APEX Trial
Journal of Thrombosis and Thrombolysis2022-12-247 citations
Budget impact analysis of betrixaban for venous thromboembolism prophylaxis in nonsurgical patients with acute medical illness in the United Kingdom
Expert Review of Pharmacoeconomics & Outcomes Research2019-06-192 citations
Characterization of Major and Clinically Relevant Non-Major Bleeds in the APEX Trial
TH Open2019-04-014 citations
Extended-duration betrixaban versus shorter-duration enoxaparin for venous thromboembolism prophylaxis in critically ill medical patients: an APEX trial substudy.
2019-02-1811 citations
Asymptomatic Deep Vein Thrombosis is Associated with an Increased Risk of Death: Insights from the APEX Trial
Thrombosis and Haemostasis2018-11-1258 citations
Inverse relationship of serum albumin to the risk of venous thromboembolism among acutely ill hospitalized patients: Analysis from the APEX trial
American Journal of Hematology2018-09-2584 citations
Increased benefit of betrixaban among patients with a history of venous thromboembolism: a post-hoc analysis of the APEX trial.
2018-01-0110 citations
Comparison of Fatal or Irreversible Events With Extended‐Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely Ill Medical Patients: An APEX Trial Substudy
Journal of the American Heart Association2017-07-0143 citations
The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis
Expert Review of Hematology2017-06-152 citations
Thrombus Burden of Deep Vein Thrombosis and Its Association with Thromboprophylaxis and D-Dimer Measurement: Insights from the APEX Trial
Thrombosis and Haemostasis2017-01-0125 citations
Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients
Circulation2016-11-1567 citations
Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients
New England Journal of Medicine2016-05-27431 citations