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Clinical trials for Betrixaban

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    3 result(s) found for: Betrixaban. Displaying page 1 of 1.
    EudraCT Number: 2008-005977-37 Sponsor Protocol Number: 08-015 Start Date*: Information not available in EudraCT
    Sponsor Name:Portola Pharmaceuticals Inc.
    Full Title: A PHASE 2, RANDOMIZED, PARALLEL GROUP, DOSE-FINDING, MULTICENTER, MULTINATIONAL STUDY OF THE SAFETY, TOLERABILITY AND PILOT EFFICACY OF THREE BLINDED DOSES OF THE ORAL FACTOR Xa INHIBITOR BETRIXABA...
    Medical condition: Antithrombotic treatment for prevention of stroke in patients with non-valvular atrial fibrillation
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003658 Atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-002562-40 Sponsor Protocol Number: 16-021 Start Date*: Information not available in EudraCT
    Sponsor Name:Portola Pharma UK Ltd
    Full Title: A phase 1, open-label, single dose, non-randomized study to evaluate pharmacokinetics, pharmacodynamics, and safety of Betrixaban in pediatric patients.
    Medical condition: 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 cour...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10053468 Anticoagulant therapy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-000255-13 Sponsor Protocol Number: 11-019 Start Date*: 2012-06-20
    Sponsor Name:Portola Pharmaceuticals, Inc.
    Full Title: Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Me...
    Medical condition: Prophylaxis of venous thromboembolism
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004865 10049909 Venous thromboembolism prophylaxis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) LV (Completed) DE (Completed) ES (Completed) GB (Completed) PL (Completed) LT (Completed) AT (Completed) DK (Completed) CZ (Completed) BG (Completed) IT (Completed) FI (Completed) SK (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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