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Clinical trials for eptacog alfa (activated)

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    17 result(s) found for: eptacog alfa (activated). Displaying page 1 of 1.
    EudraCT Number: 2019-002854-22 Sponsor Protocol Number: UGA2014-01 Start Date*: 2020-01-03
    Sponsor Name:Aryogen Pharmed
    Full Title: A RANDOMIZED, MULTICENTER, DOUBLE BLIND CLINICAL TRIAL COMPARING PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY OF A BIOSIMILAR EPTACOG ALFA (ARYOSEVEN) AND NOVOSEVEN®, IN PATIENTS WITH HAEMOPHILIA A ...
    Medical condition: HAEMOPHILIA A OR B WITH INHIBITORS
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053752 Hemophilia B with anti factor IX LLT
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adults Gender: Male
    Trial protocol: BG (Prematurely Ended)
    Trial results: (No results available)
    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: 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: 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: 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: 2011-006294-26 Sponsor Protocol Number: 021101 Start Date*: 2013-04-07
    Sponsor Name:Baxter Innovations GmbH
    Full Title: A Phase 3, Prospective, Open-label, Randomized Study to Evaluate Safety and Efficacy of Recombinant Activated FVII BI (rFVIIa BI) in the Treatment of Acute Bleeding Episodes per an On-demand Regime...
    Medical condition: Hemophilia A or B with FVIII or FIX 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: ES (Completed) BE (Completed) PL (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: 2010-023803-92 Sponsor Protocol Number: NN1731-3562 Start Date*: 2011-06-01
    Sponsor Name:Novo Nordisk A/S
    Full Title: Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients with Congenital Haemophilia and Inhibitors
    Medical condition: Congenital Haemophilia and Inhibitors
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10056492 Haemophilia A with anti factor VIII PT
    13.1 10010331 - Congenital, familial and genetic disorders 10056494 Haemophilia B with anti factor IX PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) AT (Completed) GR (Completed) PL (Completed) ES (Prematurely Ended) IT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2006-004879-35 Sponsor Protocol Number: NN1731-1804 Start Date*: 2007-11-19
    Sponsor Name:Novo Nordisk A/S
    Full Title: A multi-centre, randomised, double-blinded, controlled, dose-escalation trial on safety and efficacy of activated recombinant FVII analogue (NN1731) in the treatment of joint bleeds in congenital h...
    Medical condition: Haemophilia A with anti factor VIII and Haemophilia B with anti factor IX
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056492 Haemophilia A with anti factor VIII LLT
    9.1 10056494 Haemophilia B with anti factor IX LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) HU (Completed) IT (Prematurely Ended) FR (Completed) ES (Completed)
    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: 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: 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: 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: 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: 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: 2019-003427-38 Sponsor Protocol Number: MOTIVATE Start Date*: 2020-03-12
    Sponsor Name:HZRM – Hämophilie-Zentrum Rhein Main GmbH
    Full Title: MOdern Treatment of Inhibitor-PositiVe PATiEnts with Haemophilia A – An International Low-Interventional Pragmatic Investigator Initiated Trial
    Medical condition: Inhibitor-Positive patients with Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Trial now transitioned) NO (Trial now transitioned) SE (Trial now transitioned) FI (Trial now transitioned) HR (Trial now transitioned)
    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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