Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Coagulation factor VII

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   44338   clinical trials with a EudraCT protocol, of which   7368   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    26 result(s) found for: Coagulation factor VII. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2005-000382-19 Sponsor Protocol Number: BE1116_3001 Start Date*: 2005-09-15
    Sponsor Name:ZLB Behring GmbH
    Full Title: Efficacy and tolerance of BERIPLEX® P/N in subjects with acquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation
    Medical condition: Acquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation requiring an immediate reversal of anticoagulant effect (i.e. emergency surgery or acute bleeding).
    Disease: Version SOC Term Classification Code Term Level
    7.1 10000534 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) HU (Completed) LT (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: 2010-019250-41 Sponsor Protocol Number: 220901 Start Date*: 2010-05-27
    Sponsor Name:Baxter Innovations GmbH
    Full Title: AN INTERNATIONAL, MULTI-CENTRE, PROSPECTIVE, OPEN-LABEL, NON-RANDOMISED, UNCONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROTHROMPLEX TOTAL IN ORAL ANTICOAGULANT REVERSAL IN PATIENTS WITH A...
    Medical condition: Acquired Deficiency of Prothrombin Complex Coagulation Factors (II, VII, IX, X) due to oral anticoagulant therapy with Vitamin K antagonists
    Disease: Version SOC Term Classification Code Term Level
    12.1 10037045 Prothrombin deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) AT (Completed)
    Trial results: View results
    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: 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: 2013-005036-20 Sponsor Protocol Number: VEK40624 Start Date*: 2014-02-18
    Sponsor Name:Stellaris Pharmaceuticals ApS
    Full Title: Recombinant Factor VIIa: Local treatment of severe postpartum hemorrhage
    Medical condition: Severe postpartum bleeding
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004868 10071867 Postpartum bleeding LLT
    16.1 100000004868 10071897 Third stage postpartum bleeding LLT
    Population Age: Adults Gender: Female
    Trial protocol: DK (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: 2008-006424-54 Sponsor Protocol Number: NN7128-1907 Start Date*: 2009-06-23
    Sponsor Name:Novo Nordisk A/S
    Full Title: An Exploratory Multi-Centre, Multi-National, Randomised, Double Blinded, Parallel Arm Trial Evaluating Safety, Pharmacokinetics and Dose-finding of prophylactic administration of Long Acting rFVIIa...
    Medical condition: Haemophilia A (Factor VIII) or B with Inhibitors
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018939 Haemophilia B (Factor IX) LLT
    9.1 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: SE (Completed) GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2005-000891-42 Sponsor Protocol Number: NN1731-1668 Start Date*: 2005-09-07
    Sponsor Name:Novo Nordisk A/S
    Full Title: A randomised, open-label, multi-centre trial investigating the intra-subject variability of ROTEM® and TEG® parameters following two intravenous administrations of the same dose of activated recomb...
    Medical condition: Haemophilia
    Disease: Version SOC Term Classification Code Term Level
    7.1 10061992 LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2018-002291-41 Sponsor Protocol Number: 1 Start Date*: 2018-08-30
    Sponsor Name:Gelderse Vallei Hospital
    Full Title: The effect of administering VITamin K preprocedural on the vitamin K dependent coagulation factors and the INR in patients anticoagulated with ACEnocoumarol
    Medical condition: Adult patients using acenocoumarol and planned to undergo an invasive procedure for which the effect of the anticoagulants should be reversed.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002094-22 Sponsor Protocol Number: 2013MM002B Start Date*: 2013-08-29
    Sponsor Name:Royal Brompton and Harefield NHS Foundation Trust (RB&HFT)
    Full Title: Comparison of ultra-low-dose Oral versus Transdermal Hormone Therapy on coagulation activation and metabolic risk factors for Cardiovascular Disease
    Medical condition: The effect of oestrogen replacement therapy taken either orally or transdermally and observing any likely benefit of both these therapies on the risks Venous thromobembolic events and cardiovascul...
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038604 - Reproductive system and breast disorders 10027309 Menopause and related conditions HLGT
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-004138-12 Sponsor Protocol Number: TAK-330-3001 Start Date*: 2022-04-11
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of PROTHROMPLEX TOTAL for the Rever...
    Medical condition: Patients on treatment with Factor Xa Inhibitor needing for an urgent intervention associated with a high risk of bleeding.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-010172-21 Sponsor Protocol Number: ENJOIH01 Start Date*: 2009-08-27
    Sponsor Name:Elena Santagostino
    Full Title: An Investigator-sponsored study on rFVIIa prophylaxis in children with haemophilia A and inhibitors Estudio promovido por el investigador sobre profilaxis con rFVIIa en niños con hemofilia A e inh...
    Medical condition: Hemofilia A
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056492 Haemophilia A with anti factor VIII LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: ES (Prematurely Ended) DE (Prematurely Ended) IT (Prematurely Ended) FR (Ongoing) PL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-001309-26 Sponsor Protocol Number: CSL689_2001 Start Date*: 2015-11-09
    Sponsor Name:CSL Behring GmbH
    Full Title: A multicenter, open-label, multiple-dose, dose escalation study to investigate the pharmacokinetics, efficacy, and safety of rVIIa-FP (CSL689) in subjects with hemophilia (A or B) and inhibitors.
    Medical condition: Hemophilia A with inhibitors, Hemophilia B with inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    20.0 100000004850 10053752 Hemophilia B with anti factor IX LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed) GB (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-011186-88 Sponsor Protocol Number: ABB-09-001 Start Date*: 2009-09-08
    Sponsor Name:FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI
    Full Title: Desarrollo de inhibidores en pacientes no tratados previamente (PUP) o en pacientes mínimamente tratados con componentes sanguíneos (MBCTP) al ser expuestos a concentrados de derivados plasmáticos ...
    Medical condition: El estudio es un ensayo clínico abierto, aleatorizado, controlado, prospectivo, multicéntrico, internacional e independiente sobre la frecuencia de formación de inhibidores en pacientes no tratados...
    Disease: Version SOC Term Classification Code Term Level
    9 10018937 Haemophilia A LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: ES (Prematurely Ended) IT (Completed) PT (Completed) FR (Ongoing) DE (Completed) AT (Prematurely Ended) BE (Completed) GB (GB - no longer in EU/EEA) SK (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-003289-42 Sponsor Protocol Number: 41399 Start Date*: 2012-12-21
    Sponsor Name:Academic Medical Center Amsterdam
    Full Title: Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin versus Placebo in Burn Patients with Inhalation Trauma
    Medical condition: Burn-associated inhalation trauma requiring intubation and mechanical ventilation.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    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: 2007-003728-39 Sponsor Protocol Number: Euro SPK 003 Start Date*: 2010-12-07
    Sponsor Name:Centre Hospitalier Universitaire de Liège
    Full Title: A EUROPEAN MULTICENTER OPEN-LABEL RANDOMIZED TRIAL TO EVALUATE THE REDUCTION OF ISCHEMIA / REPERFUSION INJURY AFTER DE NOVO SIMULTANEOUS PANCREAS/KIDNEY TRANSPLANTATION IN TYPE 1-DIABETIC PATIENTS ...
    Medical condition: End-stage, C-peptide-negative, type 1-diabetic patients undergoing a first combined pancreas/kidney transplantation from a cadaver donor only will be enrolled in the study
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2004-000100-40 Sponsor Protocol Number: f7card-1610 Start Date*: 2004-08-18
    Sponsor Name:Novo Nordisk A/S
    Full Title: Estudio multicentrico. aleatorizado, doble ciego, controlado con placebo y con escalada de dosis sobre la seguridad y la eficacia del factor VII recombinante activado (rFVIIa/NovoSeven) en el trata...
    Medical condition: Enfermedad de corazon/cirugia cardiaca.
    Disease: Version SOC Term Classification Code Term Level
    10061026
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed) SE (Prematurely Ended) GB (Prematurely Ended) IT (Prematurely Ended) DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-000774-30 Sponsor Protocol Number: TA-1 Start Date*: 2013-04-24
    Sponsor Name:Amphia Hospital
    Full Title: The effect on blood loss with combined topical and intravenous tranexamic acid in cardiac surgery patients: a randomized double-blind placebo-controlled trial
    Medical condition: post-operative blood loss
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun May 25 21:35:03 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA