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Clinical trials for Coagulation factor XIII

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
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    • 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   44336   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 ).  
     
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    8 result(s) found for: Coagulation factor XIII. Displaying page 1 of 1.
    EudraCT Number: 2008-007883-41 Sponsor Protocol Number: F13CD-3720(Mentor™2) Start Date*: 2009-08-13
    Sponsor Name:Novo Nordisk A/S
    Full Title: A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency
    Medical condition: Congenital Factor XIII Deficiency
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10061992 Haemophilia PT
    14.1 10010331 - Congenital, familial and genetic disorders 10010432 Congenital deficiency of other clotting factors LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10009735 Coagulation disorders congenital HLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DE (Completed) GB (Completed) FR (Completed) ES (Completed) IT (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2006-003148-51 Sponsor Protocol Number: F13CD-1725 Start Date*: 2008-08-15
    Sponsor Name:Novo Nordisk A/S
    Full Title: A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII ...
    Medical condition: Congenital Factor XIII Deficiency
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010432 Congenital deficiency of other clotting factors LLT
    9.1 10061992 Haemophilia LLT
    9.1 10009735 Coagulation disorders congenital HLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FR (Completed) DE (Completed) AT (Completed) ES (Completed) FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000181-34 Sponsor Protocol Number: OBI-1-301 Start Date*: 2011-06-29
    Sponsor Name:Baxter Innovations GmbH
    Full Title: Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies
    Medical condition: Acquired Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004851 10053761 Acquired hemophilia with anti FVIII, XI, or XIII LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) DE (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001101-40 Sponsor Protocol Number: 13/0417 Start Date*: 2015-02-24
    Sponsor Name:University College London (UCL)
    Full Title: Sclero XIII: A phase II ,double-blind, randomized, placebo-controlled study to investigate pharmacokinetics (PK), safety and efficacy of intravenous factor XIII treatment in patients with systemic...
    Medical condition: Systemic Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004859 10010759 Connective tissue disorder NOS LLT
    17.1 100000004859 10018124 Generalized scleroderma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-006324-62 Sponsor Protocol Number: NN1810-3540 Start Date*: 2009-04-16
    Sponsor Name:Novo Nordisk A/S
    Full Title: A Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial on Efficacy and Safety of FXIII Replenishment with two different Doses of Recombinant Factor XIII following Cardiopulmonary Bypass...
    Medical condition: Aquired FXIII deficiency following cardiopulmonary bypass surgery (CABG (coronary atery bypass grafting) or CABG plus single heart valve replacement/repairs or planned replacement/repair of a singl...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063919 Bypass surgery LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) DK (Completed) ES (Completed) GB (Completed) IT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-000026-44 Sponsor Protocol Number: 2007-04-04 Start Date*: 2007-04-19
    Sponsor Name:Aarhus Universityhospital
    Full Title: Hydroxyethylstarch induced coagulopathy and haemostatic potential of fibrinogen - in vivo placebo controlled clinical trial.
    Medical condition: The present study evaluates dilution coagulopathy induced by hydroxyethyl starch solutions in a clinical setting on patients undergoeing cystektomia due to bladder cancer. Furteher the haemostatic ...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10060906 Dilutional coagulopathy PT
    9.1 10016595 Fibrinogen LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-004139-29 Sponsor Protocol Number: RETIC Start Date*: 2011-12-06
    Sponsor Name:Medizinische Universität Innsbruck / UK für Anästhesie und Intensivmedizin & UK für Allgem. u. Chirurg. Intensivmedizin
    Full Title: RETIC trial: Reversal of Trauma Induced Coagulopathy by using Coagulation factor concentrates or Fresh frozen Plasma
    Medical condition: Major trauma (Injury Severity Score, ISS >15), clinical signs/risk of blood loss and coagulopathy as measured by rotational thrombelastometry (ROTEM)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10047065 - Vascular disorders 10018988 Haemorrhage NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-005682-12 Sponsor Protocol Number: H-2-2012_089 Start Date*: 2013-07-03
    Sponsor Name:Dept. of Clinical Immunology
    Full Title: THE EFFECT OF PLASMA ON THE ENDOTHELIUM IN CRITICAL ILLNESS
    Medical condition: Pilot study in healthy subjects with a perspective for treating of serious conditions such as sepsis, septic shock, trauma and severe haemorrhage
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004866 10054438 Ischemia LLT
    16.0 100000004866 10019595 Hemorrhage, unspecified LLT
    16.0 100000004862 10040580 Shock septic LLT
    16.0 100000004863 10044461 Trauma LLT
    Population Age: Adults Gender: Male
    Trial protocol: DK (Completed)
    Trial results: (No results available)
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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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