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Clinical trials for Direct thrombin inhibitors

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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    6 result(s) found for: Direct thrombin inhibitors. Displaying page 1 of 1.
    EudraCT Number: 2012-004863-29 Sponsor Protocol Number: 1M Start Date*: 2013-02-18
    Sponsor Name:University Hospitals Leuven (Gasthuisberg) [...]
    1. University Hospitals Leuven (Gasthuisberg)
    2. agentschap innoveren en ondernemen
    Full Title: Direct thrombin inhibitors versus low molecular weight heparins as thromboprophylaxis in Staphylococcus aureus bacteraemia. A prospective randomized controlled academic single-centre feasibility st...
    Medical condition: staphylococcus aureus bacteraemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-001639-35 Sponsor Protocol Number: M602011014 Start Date*: 2019-11-26
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity caused by stroke or traumatic...
    Medical condition: Diagnosis of lower limb spasticity with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10058977 Spastic paresis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) NO (Completed) CZ (Trial now transitioned) GB (GB - no longer in EU/EEA) ES (Ongoing) IT (Trial now transitioned) HU (Trial now transitioned) SK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-001785-26 Sponsor Protocol Number: 14-505 Start Date*: 2016-02-15
    Sponsor Name:Portola Pharmaceuticals, Inc.
    Full Title: Prospective, Open-label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor who Have Acute Major Bleeding (ANNEXA-4).
    Medical condition: Uncontrolled bleeding in patients who have taken either a direct factor Xa inhibitor (novel oral anticoagulants) or an indirect factor Xa inhibitor (low molecular weight heparins).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000022097 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (Completed) BE (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-003232-24 Sponsor Protocol Number: AVA-PED-301 Start Date*: 2020-12-03
    Sponsor Name:Dova Pharmaceuticals, Inc.
    Full Title: A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment...
    Medical condition: Thrombocytopenia in paediatric subjects with immune thrombocytopenia for ≥6 months duration who have had an insufficient response to a previous treatment
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043555 Thrombocytopenias HLT
    23.0 10005329 - Blood and lymphatic system disorders 10083843 Primary immune thrombocytopenia LLT
    23.0 10005329 - Blood and lymphatic system disorders 10083842 Immune thrombocytopenia PT
    20.0 10005329 - Blood and lymphatic system disorders 10035534 Platelet disorders HLGT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) HU (Completed) DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-013425-42 Sponsor Protocol Number: 901 Start Date*: 2009-08-14
    Sponsor Name:Atrium Medical Corporation [...]
    1. Atrium Medical Corporation
    2. Cardiovascular Research Foundation
    Full Title: A 2x2 Factorial, Randomized, Multicenter, Single-Blind Evaluation of Intracoronary Abciximab Infusion and Aspiration Thrombectomy in Patients Undergoing Percutaneous Coronary Intervention for Anter...
    Medical condition: The study population will consist of up to 452 male and female subjects with anterior STEMI and occluded proximal or mid LAD with TIMI 0/1 flow with indication for primary PCI.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10000891 Acute myocardial infarction LLT
    9.1 10000904 Acute myocardial infarction, of other anterior wall LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) AT (Completed) GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003894-26 Sponsor Protocol Number: 1160.26 Start Date*: 2005-12-23
    Sponsor Name:Boehringer Ingelheim AB
    Full Title: Randomized Evaluation of Long term anticoagulant therapy (RE-LY) comparing the efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke...
    Medical condition: Prevention of Stroke and Systemic Embolism in patients with Atrial Fibrillation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) FI (Completed) CZ (Completed) AT (Completed) HU (Completed) DE (Completed) SK (Completed) IT (Completed) ES (Completed) GB (Completed) PT (Completed) GR (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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