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Clinical trials for Recombinant factor VIIa

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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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44353   clinical trials with a EudraCT protocol, of which   7380   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: Recombinant factor VIIa. Displaying page 1 of 1.
    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: 2004-000088-92 Sponsor Protocol Number: F7CBI-1600 Start Date*: 2004-08-23
    Sponsor Name:Novo Nordisk A/S
    Full Title: A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa (NovoSeven®/Niastase®) with Brain Cont...
    Medical condition: Contusive Brain Injury
    Disease: Version SOC Term Classification Code Term Level
    6.1 10052346 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-004779-11 Sponsor Protocol Number: RB-FVIIa-006-13 Start Date*: 2014-07-03
    Sponsor Name:rEVO Biologics, Inc.
    Full Title: A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients with Inhibitors to Factor VIII or IX
    Medical condition: Congenital haemophilia A or B patients with inhitors to Factor VIII or Factor IX
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    18.0 100000004850 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) BG (Completed) RO (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-000958-38 Sponsor Protocol Number: LFB-FVIIa-007-14 Start Date*: 2016-01-06
    Sponsor Name:LFB USA, Inc.
    Full Title: A Phase III Study on the Safety, Pharmacokinetics, and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Pediatric Patients from birth to <12 years old with Inhibit...
    Medical condition: Congenital Hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10056492 Haemophilia A with anti factor VIII PT
    19.1 10010331 - Congenital, familial and genetic disorders 10056494 Haemophilia B with anti factor IX PT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: CZ (Completed) BG (Completed) IT (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: 2019-003722-25 Sponsor Protocol Number: U1111-1201-0087 Start Date*: 2020-12-14
    Sponsor Name:University of Cincinnati
    Full Title: rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
    Medical condition: Acute haemorrhagic stroke
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10048863 Hemorrhagic stroke LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) GB (GB - no longer in EU/EEA)
    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
    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: 2011-000323-33 Sponsor Protocol Number: BAY86-6150,IMPACT15534 Start Date*: 2012-09-25
    Sponsor Name:Bayer HealthCare AG
    Full Title: A Phase 2/3, multicenter, open-label clinical study to assess the safety and efficacy of BAY86-6150 in subjects with hemophilia A or B with inhibitors, composed of 2 Parts (A & B). Part A: Sequenti...
    Medical condition: Subjects with hemophilia A or B with inhibitors
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    14.1 100000004850 10053752 Hemophilia B with anti factor IX LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Prematurely Ended) HU (Prematurely Ended) PL (Prematurely Ended) DK (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-002059-41 Sponsor Protocol Number: F7Trauma-1711 Start Date*: 2005-07-07
    Sponsor Name:Novo Nordisk A/S
    Full Title: A multi-center, randomized, double-blind, parallel group, placebo controlled trial to evaluate the efficacy and safety of activated recombinant factor VII (rFVIIa/NovoSeven®/NiaStase®) in severely ...
    Medical condition: Traumatic Hemorrhage
    Disease: Version SOC Term Classification Code Term Level
    8.0 10053476 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) BE (Completed) GB (Completed) ES (Completed) CZ (Completed) IT (Completed) FI (Completed) SE (Completed) PT (Prematurely Ended) SI (Completed) GR (Completed) HU (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: 2004-004202-24 Sponsor Protocol Number: F7ICH-1641 Start Date*: 2005-04-29
    Sponsor Name:Novo Nordisk A/S
    Full Title: Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral ...
    Medical condition: Acute Intracerebral Haemorrhage
    Disease: Version SOC Term Classification Code Term Level
    7.1 10022753 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed) SE (Completed) NO (Completed) DK (Completed) IT (Completed) BE (Completed) AT (Completed) GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-003660-31 Sponsor Protocol Number: B7841005 Start Date*: 2020-09-07
    Sponsor Name:Pfizer Inc.
    Full Title: An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A or B Patients With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis
    Medical condition: Hemophilia A or B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000004850 10060612 Hemophilia A LLT
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended) FR (Completed) BG (Completed) GB (GB - no longer in EU/EEA) ES (Restarted) IE (Completed) HR (Completed) IT (Completed)
    Trial results: (No results available)
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