Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Haemophilia B With Inhibitors

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   44351   clinical trials with a EudraCT protocol, of which   7378   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
     
    86 result(s) found for: Haemophilia B With Inhibitors. Displaying page 4 of 5.
    « Previous 1  2  3  4  5  Next»
    EudraCT Number: 2009-012149-43 Sponsor Protocol Number: BAY81-8973/12954 Start Date*: 2010-09-06
    Sponsor Name:Bayer HealthCare AG
    Full Title: Ensayo aleatorizado, cruzado, abierto, en dos partes, para evaluar la farmacocinética, la eficacia y el perfil de seguridad de FVIII recombinante libre de proteínas plasmáticas formulado con sacaro...
    Medical condition: Hemofilia A severa (< 1% FVIII:C)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10053753 Hemophilia A without inhibitors LLT
    12.1 10060612 Hemophilia A LLT
    12.1 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: ES (Completed) SE (Completed) GB (Completed) NO (Completed) DE (Completed) IT (Completed) AT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2018-002776-40 Sponsor Protocol Number: SubQ8-01 Start Date*: 2019-01-24
    Sponsor Name:Octapharma AG
    Full Title: Phase 1/2 study to assess the safety and pharmacokinetic of subcutaneous injection of OCTA101 in previously treated adult patients with severe hemophilia A
    Medical condition: Severe hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2022-004149-11 Sponsor Protocol Number: TAK-761-4009 Start Date*: 2023-07-27
    Sponsor Name:Takeda Biopharmaceuticals India Pvt. Ltd.
    Full Title: Phase 4, Multicenter, Prospective, Interventional, Post-Marketing Study in Hemophilia A Patients in India Receiving ADVATE as On-Demand or Prophylaxis Under Standard Clinical Practice
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-022726-33 Sponsor Protocol Number: 251001 Start Date*: 2011-03-24
    Sponsor Name:Baxter Innovations GmbH
    Full Title: BAX326 (recombinant Factor IX): Evaluation of Safety, Immunogenicity, and Hemostatic Efficacy in Previously Treated Patients with Severe (FIX level < 1%) or Moderately Severe (FIX level 1- 2%) Hemo...
    Medical condition: Previously treated patients (PTPs) with severe (FIX level < 1%) or moderately severe (FIX level 1- 2%) hemophilia B.
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BG (Completed) CZ (Completed) GB (Completed) DE (Prematurely Ended) SE (Completed) PL (Completed) ES (Completed) IT (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2011-003073-28 Sponsor Protocol Number: 8HA02PED Start Date*: 2012-05-31
    Sponsor Name:Biogen Idec Research Ltd
    Full Title: An Open-Label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB031, in the Prevention and Treatment of Bleeding Episod...
    Medical condition: Severe Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10053753 Hemophilia A without inhibitors LLT
    14.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: GB (Completed) IE (Completed) NL (Completed) PL (Completed)
    Trial results: View results
    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: 2009-014295-21 Sponsor Protocol Number: 998HB102 Start Date*: 2010-05-06
    Sponsor Name:Biogen Idec Hemophilia Inc.
    Full Title: B-LONG: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant, Long-acting Coagulation Factor IX Fc fusion protein (rFIXFc) in the Prevention and Treat...
    Medical condition: The medical condition to be investigated is Hemophilia B, or Christmas disease. Hemophilia B is a deficiency in the clotting FIX and is a recessively inherited coagulation disorder due to an X-chro...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10053754 Hemophilia B without inhibitors LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: SE (Completed) GB (Completed) DE (Completed) FR (Completed) PL (Completed) BE (Completed) IT (Completed) NL (Ongoing)
    Trial results: View results
    EudraCT Number: 2008-007016-15 Sponsor Protocol Number: RES.I.ST. NAÏVE Start Date*: 2008-12-24
    Sponsor Name:FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI
    Full Title: RANDOMISED STUDY OF FIRST CHOICE IMMUNOTOLERANCE INDUCTION IN PATIENTS WITH SEVERE TYPE A HAEMOPHILIA WITH INHIBITOR AT HIGH RISK OF FAILURE: COMPARISON OF INDUCTION OF IMMUNE TOLERANCE WITH FVIII ...
    Medical condition: SEVERE TYPE A HAEMOPHILIA
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010432 Congenital deficiency of other clotting factors LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: IT (Ongoing) ES (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2004-003727-12 Sponsor Protocol Number: 3082A-101711 Start Date*: 2005-05-09
    Sponsor Name:Wyeth Pharmaceuticals, Global Medical Affairs
    Full Title: A Single Dose, Randomized, 2-Period Crossover Study in Patients with Hemophilia A to Evaluate the Pharmacokinetics of Refacto(B-domain deleted recombinant human factor VIII (BDDrFVIII) and Advate (...
    Medical condition: Hemophilia A
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-005575-17 Sponsor Protocol Number: 3082B2-313-WW Start Date*: 2008-04-07
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: An Open-Label Study to Evaluate Prophylaxis Treatment, and to Characterize the , Efficacy, Safety and Pharmacokinetics of B Domain Deleted Recombinant Factor VIII Albumin Free (ReFacto AF) in Child...
    Medical condition: Younger Male Haemophilia A patients < 6 years of age with moderately severe to severe hemophilia A (FVIII activity =< 2%), with previous FVIII replacement therapy experience (>=50 exposure days). ...
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: ES (Completed) DE (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-003076-36 Sponsor Protocol Number: 9HB02PED Start Date*: 2012-05-29
    Sponsor Name:Biogen Idec Research Ltd
    Full Title: Open-label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in the Prevention and Treatment of Bleeding Episodes in...
    Medical condition: The medical condition to be investigated is Hemophilia B, or Christmas disease. Hemophilia B is a deficiency in the clotting FIX and is a recessively inherited coagulation disorder due to an X-chro...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10053754 Hemophilia B without inhibitors LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: GB (Completed) IE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-000181-34 Sponsor Protocol Number: OBI-1-301 Start Date*: 2011-06-29
    Sponsor Name:Baxter Innovations GmbH
    Full Title: Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies
    Medical condition: Acquired Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004851 10053761 Acquired hemophilia with anti FVIII, XI, or XIII LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) DE (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-005210-11 Sponsor Protocol Number: BAY94-9027/13024 Start Date*: 2012-06-25
    Sponsor Name:Bayer AG
    Full Title: A Phase II/III, multicenter, partially randomized, open label trial investigating safety and efficacy of on-demand and prophylactic treatment with BAY 94-9027 in Severe Hemophilia A
    Medical condition: Severe Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (Completed) BE (Completed) NL (Completed) NO (Completed) AT (Completed) DE (Completed) DK (Completed) PL (Completed) FR (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005524-26 Sponsor Protocol Number: GBI1406 Start Date*: 2016-07-29
    Sponsor Name:Grifols Biologicals Inc.
    Full Title: A Multicenter Phase 2 Open-Label, Single-Arm, Prospective, Interventional Study of Plasma-Derived Factor VIIIIVWF Alphanate® in Immune Tolerance Induction Therapy in Subjects with Congenital Hemoph...
    Medical condition: Inhibitors in patients with severe Congenital Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004851 10018847 Haematological disorders HLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: ES (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000608-39 Sponsor Protocol Number: 21-ItolDC-028-01 Start Date*: 2022-09-20
    Sponsor Name:Idogen AB
    Full Title: An open-label, multi-center, first in human, phase 1/2a trial to evaluate the safety and preliminary efficacy of autologous tolerogenic dendritic cells ex vivo loaded with recombinant Factor VIII (...
    Medical condition: Treatment of patients with Hemophilia A who have developed inhibitory antibodies to clotting Factor VIII and have failed Immune Tolerance Induction
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adults Gender: Male
    Trial protocol: NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-001426-84 Sponsor Protocol Number: WIL-14 Start Date*: 2006-02-09
    Sponsor Name:Octapharma AG
    Full Title: CLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASE
    Medical condition: Inherited von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    8.0 10047715 PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2020-004344-28 Sponsor Protocol Number: WIL-33 Start Date*: 2022-08-15
    Sponsor Name:Octapharma Pharmazeutika Produktionsges.m.b.H.
    Full Title: CLINICAL STUDY TO INVESTIGATE THE EFFICACY, PHARMACOKINETICS, IMMUNOGENICITY AND SAFETY OF WILATE IN SEVERE VON WILLEBRAND DISEASE PATIENTS UNDER THE AGE OF 6 YEARS
    Medical condition: Routine prophylaxis in children under the age of 6 years with severe VWD
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000073-21 Sponsor Protocol Number: BH29992 Start Date*: 2016-05-12
    Sponsor Name:Roche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd
    Full Title: A SINGLE-ARM, MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ONCE WEEKLY SUBCUTANEOUS ADMINISTRATION OF EMICIZUMAB IN HEMOPHILIA A PEDIA...
    Medical condition: Hemophilia A with Inhibitors
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003450-92 Sponsor Protocol Number: IG1005 Start Date*: 2013-11-23
    Sponsor Name:Instituto Grifols S.A.
    Full Title: EVALUATION OF THE PHARMACOKINETIC PROFILE, CLINICAL EFFICACY AND SAFETY OF THE VON WILLEBRAND FACTOR CONTAINED IN FANHDI® (DOUBLE-INACTIVATED HUMAN ANTI-HEMOPHILIC FACTOR) IN PEDIATRIC PATIENTS WIT...
    Medical condition: Severe von Willebrand disease including types I, II, and III with VWF:RCof <15-20%
    Disease: Version SOC Term Classification Code Term Level
    14.1 10022891 - Investigations 10068986 Von Willebrand's factor activity decreased PT
    14.1 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    14.1 10010331 - Congenital, familial and genetic disorders 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003305-25 Sponsor Protocol Number: CSLCT-BIO-12-83 Start Date*: 2015-07-07
    Sponsor Name:CSL Behring GmbH
    Full Title: An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease
    Medical condition: Von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) AT (Completed) IE (Completed) PL (Completed) GR (Completed)
    Trial results: View results
    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.
    « Previous 1  2  3  4  5  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-Sat Jul 26 02:51:28 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA