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Clinical trials for Factor VII deficiency

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   44335   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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    13 result(s) found for: Factor VII deficiency. Displaying page 1 of 1.
    EudraCT Number: 2020-003371-18 Sponsor Protocol Number: MAA-202 Start Date*: 2021-03-30
    Sponsor Name:Catalyst Biosciences, Inc.
    Full Title: Phase 1/2 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Marzeptacog alfa (activated) in Treatment of Episodic Bleeding in Subjects with Inherited Bleeding Disorders
    Medical condition: Factor VII deficiency, Glanzmann thrombasthenia (GT) and Hemophilia A with inhibitors on emicizumab prophylaxis (HAwI-E)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10016079 Factor VII deficiency PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    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: 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: 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: 2021-004858-30 Sponsor Protocol Number: BAY94-9027/21824 Start Date*: 2022-09-05
    Sponsor Name:Bayer Consumer Care AG
    Full Title: A phase 3, single group treatment, open-label, study to evaluate the safety of BAY 94-9027 infusions for prophylaxis and treatment of bleeding in previously treated children aged 7 to <12 years wit...
    Medical condition: Severe hemophilia A (<1% FVIII:C)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: NO (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    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: 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: 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: 2020-000996-19 Sponsor Protocol Number: MAA-304 Start Date*: Information not available in EudraCT
    Sponsor Name:Catalyst Biosciences, Inc.
    Full Title: Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous Marzeptacog Alfa (Activated) For On-Demand Treatment and Control of Bleeding Episodes in Subjects with Haemophilia A or Haemophilia...
    Medical condition: Marzeptacog alfa (activated) (MarzAA), a novel activated recombinant Factor VII (rFVIIa) variant, is being developed by Catalyst Biosciences to address the unmet need in haemophilia and other bleed...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10066439 Hemophilia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Prematurely Ended) PL (Prematurely Ended) DK (Prematurely Ended) BG (Prematurely Ended) IT (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: 2013-000883-27 Sponsor Protocol Number: Rif_CVID_260611 Start Date*: 2013-08-16
    Sponsor Name:Oslo University hospital
    Full Title: EFFECTS OF RIFAXIMIN, BY MODULATION OF THE GUT MICROBIOTA, ON MARKERS OF SYSTEMIC INFLAMMATION IN PATIENTS WITH COMMON VARIABLE IMMUNODEFICIENCY - AN EXPLORATORY OPEN-LABEL RANDOMIZED CONTROLLED TRIAL
    Medical condition: Adult patients with the diagnosis of Common variable deficiency and fulfill the inclusion and exclusion criteria, will be invited to participate in the study.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-001528-37 Sponsor Protocol Number: Cholzuur Start Date*: 2020-04-09
    Sponsor Name:Cbusinez
    Full Title: Long-term safety study of personalized magistral prepared cholic acid capsules in patients with bile acid synthesis defects
    Medical condition: Patients with phenotypically mild Zellweger Spectrum Disorder (ZSD) or a Single Enzyme Defect (SED) in bile acid synthesis.
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000510-30 Sponsor Protocol Number: NN7415-4310 Start Date*: 2017-06-08
    Sponsor Name:Novo Nordisk A/S
    Full Title: A Multi-Centre, Randomised, Open-Label, Controlled Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients with Inhibitors
    Medical condition: Haemophilia A with inhibitors Haemophilia 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: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) DK (Completed) GB (Completed) GR (Prematurely Ended) ES (Completed) AT (Completed) HR (Completed) IT (Completed)
    Trial results: View results
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