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Clinical trials for "human coagulation factor X"

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   44337   clinical trials with a EudraCT protocol, of which   7367   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 ).  
     
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    8 result(s) found for: "human coagulation factor X". Displaying page 1 of 1.
    EudraCT Number: 2012-003093-98 Sponsor Protocol Number: Ten02 Start Date*: 2015-02-24
    Sponsor Name:Bio Products Laboratory Limited
    Full Title: A Phase III Open, Multicentre Study to Confirm the Safety, Pharmacokinetics and Efficacy of BPL’s High Purity Factor X in the Prophylaxis of Bleeding in Factor X Deficient Children Under the Age of...
    Medical condition: Factor X Deficiency
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-005206-31 Sponsor Protocol Number: 2006-09 Start Date*: 2007-01-25
    Sponsor Name:Örebro University Hospital
    Full Title: Perioperative Morbidity in Elderly patients undergoing Surgery for Fracture Neck of Femur. The Effect of Plasma or Ocplex® for reversal of Warfarin anticoagulation.
    Medical condition: Patients undergoing surgery for the repair of fracture neck of femur that are on chronic oral warfarin sodium as anticoagulation prophylactics.
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-004484-31 Sponsor Protocol Number: Riva-PCC Start Date*: 2014-01-10
    Sponsor Name:Medizinische Universität Innsbruck / Allg. u. chirug. Intensivmedizin
    Full Title: Rivaroxaban and PCC: Prothrombin Complex Concentrate in patients with bleeding complications related to Rivaroxaban
    Medical condition: blood coagulation disorder
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004848 10009728 Coagulation and bleeding analyses HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-015086-31 Sponsor Protocol Number: Ten03 Start Date*: 2010-03-16
    Sponsor Name:Bio Products Laboratory Limited
    Full Title: Ten03: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL’s High Purity Factor X in the treatment of the Factor X Deficient Subjects Undergoing Surgery
    Medical condition: Factor X Deficiency
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-007861-19 Sponsor Protocol Number: BE1116_3002 Start Date*: 2009-01-16
    Sponsor Name:CSL Behring GmbH
    Full Title: An open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of BERIPLEX® P/N compared with plasma for rapid reversal of coagulopathy induced by coumarin der...
    Medical condition: Therapy of major bleeding resulting from an acquired deficiency of vitamin K-dependent coagulation factors and proteins C and S due to use of oral anticoagulation therapy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009789 Coagulation factors decreased LLT
    9.1 10005103 Bleeding LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2007-007862-39 Sponsor Protocol Number: BE1116_3003 Start Date*: 2009-01-16
    Sponsor Name:CSL Behring GmbH
    Full Title: An open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of BERIPLEX® P/N compared with plasma for rapid reversal of coagulopathy induced by vitamin K an...
    Medical condition: Perioperative prophylaxis for emergency surgery in subjects who have an acquired deficiency of vitamin K-dependent coagulation factors and proteins C and S
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10065667 Haemorrhage prophylaxis PT
    14.1 100000004848 10009789 Coagulation factors decreased LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) PL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-011145-18 Sponsor Protocol Number: TEN01 Start Date*: 2009-11-02
    Sponsor Name:Bio Products Laboratory Ltd
    Full Title: A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency
    Medical condition: Factor X deficiency
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10052474 Factor X deficiency PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-003041-41 Sponsor Protocol Number: 012507 Start Date*: 2018-11-16
    Sponsor Name:Queen Mary University of London
    Full Title: A pragmatic pilot randomised controlled trial of Prothrombin Complex Concentrate (PCC) versus Fresh Frozen Plasma (FFP) in adult patients who are undergoing Heart Surgery
    Medical condition: Major bleeding during cardiac surgery not related to vitamin K antagonists
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004863 10051536 Intraoperative bleeding LLT
    20.1 100000004863 10036277 Postoperative bleeding LLT
    21.1 10042613 - Surgical and medical procedures 10042609 Surgery PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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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