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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   44341   clinical trials with a EudraCT protocol, of which   7370   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.
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    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.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
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    Study title: A Postlicensing Study to Determine Long-Term Safety of Alphanate® in Previously-Treated Patients Diagnosed with Severe Hemophilia A
    Active substance: HUMAN COAGULATION FACTOR VII
    Study summary document link (including results):
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    Document reference: 29144
    Study title: Clinical Study of Recovery and Half-Life of Factor VII Concentrate (Human Immuno 1988-1991)
    Active substance: HUMAN COAGULATION FACTOR VII
    Study summary document link (including results):
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    Document reference: 29142
    Study title: Compassionate Use of Factor VII, VH
    Active substance: HUMAN COAGULATION FACTOR VII
    Study summary document link (including results):
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    Document reference: 29141
    Study title: Low risk if viral infection after administration of vapor heated factor VII concentrate or factor IX complex in first time recipients of blood components
    Active substance: HUMAN COAGULATION FACTOR VII
    Study summary document link (including results):
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    Document reference: 29140
    Study title: Open-Label Clinical Study of Long-Term Treatment and Prophylaxis with Factor VII Concentrate (Human) Immuno, Vapor Heated"
    Active substance: HUMAN COAGULATION FACTOR VII
    Study summary document link (including results):
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    Document reference: 29138
    Study title: Single Patient Use of Factor VII Concentrate
    Active substance: HUMAN COAGULATION FACTOR VII
    Study summary document link (including results):
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    Document reference: 29143
    Study title: Study to determine the safety of virus inactivated factor concentrates in hemophiliacs naive to blood product administration (IFSS)
    Active substance: HUMAN COAGULATION FACTOR VII
    Study summary document link (including results):
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    Document reference: 29139
    Study title: A study on the safety and efficacy of FEIBA VH Immuno in Hemophilia Patients with Inhibitors Hemophiliac Treatment Research Study
    Active substance: HUMAN COAGULATION FACTOR VIII
    Study summary document link (including results): 05 ATG95-03 (full).pdf
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    Document reference: 29148
    Study title: Clinical study to investigate the efficacy, safety and immunogenicity of Wilate in children < 6 years of age with inherited von willebrand disease.
    Active substance: HUMAN COAGULATION FACTOR VIII
    Study summary document link (including results):
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    Document reference: 29157
    Study title: Efficacy and safety in children with severe Haemophilia A treated with OCTANATE (Phase III)
    Active substance: HUMAN COAGULATION FACTOR VIII
    Study summary document link (including results):
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    Document reference: 29156
    Study title: Efficacy of factor VIII/von Willebrand factor concentrate Alphanate in preventing excessive bleeding during surgery or invasive procedures in subjects with congenital von Willebrand disease
    Active substance: HUMAN COAGULATION FACTOR VIII
    Study summary document link (including results):
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    Document reference: 29146
    Study title: Efficacy Study of FEIBA IMMUNO Vapor Heated Versus Factor IX Complex (Human) IMMUNO, Vapor Heated, in the Management of Patients with Hemophilia A with Inhibitors
    Active substance: HUMAN COAGULATION FACTOR VIII
    Study summary document link (including results):
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    Document reference: 29150
    Study title: Evaluation of the Pharmacokinetic, Clinical Efficacyand Safety of the Concentrate of Factor VIII, Emoclot D.I., in patients affected by Haemophilia A
    Active substance: HUMAN COAGULATION FACTOR VIII
    Study summary document link (including results): 06 IG95-01B (full).pdf
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    Document reference: 29154
    Study title: Familiarization Phase of FEIBA Immuno Study (Hilgartner)
    Active substance: HUMAN COAGULATION FACTOR VIII
    Study summary document link (including results): 03 IG405 (synopsis).pdf
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    Document reference: 29149
    Study title: Human Plasma derived Antihemophilic Factor VIII: Evaluation of Efficacy, Tolerability and Safety in Previously Treated Severe Hemophilia A Patients. An Open non-Comparative Phase III Study.
    Active substance: HUMAN COAGULATION FACTOR VIII
    Study summary document link (including results):
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    Document reference: 29153
    Study title: IG 95-01B: Retrospective pharmacovilance study. Safety study on the double-inactivated human antihaemophilic factor concentrate (Fanhdi) Grifols, during prophylaxis and/or treatment of patients with haemophilia A.
    Active substance: HUMAN COAGULATION FACTOR VIII
    Study summary document link (including results):
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    Document reference: 29151
    Study title: Incidence of inhibitors in previously untreated patients with severe haemophilia A treated with Octanate
    Active substance: HUMAN COAGULATION FACTOR VIII
    Study summary document link (including results): 04 UK95-02 (full).pdf
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    Document reference: 29155
    Study title: Post Marketing Pharmacovigilance Study (ATC 9503) with Profilate (SD, HT)
    Active substance: HUMAN COAGULATION FACTOR VIII
    Study summary document link (including results):
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    Document reference: 29145
    Study title: Report UK 95-02: Retrospective review of inhibitor formation in a cohort of haemophilia A patients who received Alphanate (Alpha 8 ST) prophylactically
    Active substance: HUMAN COAGULATION FACTOR VIII
    Study summary document link (including results):
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    Document reference: 29152
    Study title:
    Active substance: HUMAN COAGULATION FACTOR VIII AND HUMAN VON WILLEBRAND FACTOR
    Study summary document link (including results):
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    Document reference: 29159
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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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