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Clinical trials for 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
  • 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   43892   clinical trials with a EudraCT protocol, of which   7299   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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    19 result(s) found for: Factor Xiii. Displaying page 1 of 1.
    EudraCT Number: 2009-010387-41 Sponsor Protocol Number: BI71023_2002 Start Date*: 2009-06-25
    Sponsor Name:CSL Behring LLC
    Full Title: A 12-week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congential Factor XIII Deficiency Estudio de 12 semanas, multicéntrico, de...
    Medical condition: Congenital Factor XIII deficiency Deficiencia congénita de factor XIII
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016083 Factor XIII deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-003764-20 Sponsor Protocol Number: BI71023_3002 Start Date*: 2015-03-11
    Sponsor Name:CSL Behring LLC
    Full Title: A Prospective, Multicenter, Open Enrollment Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency
    Medical condition: Congenital Factor XIII deficiency
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10016083 Factor XIII deficiency PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-010722-19 Sponsor Protocol Number: BI71023_3001 Start Date*: 2009-11-04
    Sponsor Name:CSL Behring LLC
    Full Title: A Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congenital Factor XIII Deficiency Estudio prospectivo, multicéntrico, con et...
    Medical condition: Congenital Factor XIII deficiency Deficiencia congénita de factor XIII
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016083 Factor XIII deficiency LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-020192-23 Sponsor Protocol Number: F13CD-3835 Start Date*: 2010-09-20
    Sponsor Name:Novo Nordisk A/S
    Full Title: A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Efficacy of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Paediatric Subjects wi...
    Medical condition: Congenital Factor XIII A-subunit Deficiency
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10016083 Factor XIII deficiency PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-016869-28 Sponsor Protocol Number: F13CD-3760 (mentor™4) Start Date*: 2010-09-20
    Sponsor Name:Novo Nordisk A/S
    Full Title: A Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose of rFXIII in Paediatric (1 to less than 6 Years Old) Subjects with Congenital FXIII A-subunit Def...
    Medical condition: Congenital FXIII A-subunit Deficiency
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10016083 Factor XIII deficiency PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (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: 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: 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: 2009-017804-95 Sponsor Protocol Number: ATRHEMOS/1 Start Date*: 2010-03-05
    Sponsor Name:Fundació Institut de Recerca de l?Hospital de la Santa Creu i Sant Pau
    Full Title: Prevención del sangrado postoperatorio: Ensayo clínico unicéntrico, aleatorizado, paralelo y controlado que evalúa la eficacia de la cola de fibrina y el ácido tranexámico en pacientes intervenidos...
    Medical condition: Pacientes que precisan de una artroplastia de rodilla. Patients with are needed of an arthroplasty of the knee.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    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: 2011-001568-22 Sponsor Protocol Number: NN8717-3946 Start Date*: 2013-01-15
    Sponsor Name:Novo Nordisk A/S
    Full Title: A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis
    Medical condition: Mild to moderate Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) DK (Prematurely Ended) BG (Completed)
    Trial results: View results
    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: 2007-003006-98 Sponsor Protocol Number: PROT-TISSUCOL-001 Start Date*: 2007-07-16
    Sponsor Name:Cirugía General II. Hospital General Universitario “Gregorio Marañón”
    Full Title: ESTUDIO FASE IV, UNICENTRICO, ALEATORIZADO, SIMPLE CIEGO, CONTROLADO, COMPARATIVO DE DOS GRUPOS PARALELOS PARA EVALUAR LA EFICACIA DE TISSUCOL DUO (ADHESIVO BIOLOGICO A BASE DE FIBRINA) EN LA PREVE...
    Medical condition: Defectos de cicatrización (fístulas, dehiscencias y fugas subclínicas) en la(s) anastomosis(s) de tubo digestivo de alto riesgo: Las anastomosis consideradas de alto riesgo son: 1. Anastomosis rect...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10058066 Perforation of anastomosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004692-40 Sponsor Protocol Number: PPL20 Start Date*: 2021-03-30
    Sponsor Name:Dilafor AB
    Full Title: An Exploratory, Open label, Randomized, Parallel-Group, Pilot Study to evaluate Safety, Tolerability and Efficacy of daily, subcutaneous tafoxiparin treatment from the time of diagnosis for up to 4...
    Medical condition: Preeclampsia diagnosed at week 26-32 of gestation.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004868 10040444 Severe pre-eclampsia LLT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001286-28 Sponsor Protocol Number: CA209172 Start Date*: 2014-09-24
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Single-Arm, Open-Label, Multicenter Clinical Trial with Nivolumab (BMS-936558) for Subjects with Histologically Confirmed Stage III (unresectable) or Stage IV Melanoma Progressing After Prior Tre...
    Medical condition: Histologically Confirmed Stage III (unresectable) or Stage IV Melanoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025671 Malignant melanoma stage IV PT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025670 Malignant melanoma stage III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IT (Completed) DE (Completed) GB (Completed) ES (Completed) NL (Completed) AT (Completed) DK (Completed) PT (Completed) IE (Completed) SE (Completed) FI (Completed) HU (Completed) CZ (Completed) GR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2005-002741-39 Sponsor Protocol Number: TIMELI001 Start Date*: 2005-12-07
    Sponsor Name:Prof. Giampiero CAMPANELLI
    Full Title: A prospective, controlled, randomized, patient and evaluator blinded study to evaluate pain and further disabling complications in patients undergoing Lichtenstein technique for primary inguinal he...
    Medical condition: Unilateral, uncomplicated primary inguinal hernia repair
    Disease: Version SOC Term Classification Code Term Level
    10022020
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) DE (Completed) ES (Completed) DK (Completed) IT (Completed)
    Trial results: (No results available)
    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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