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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
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    • 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   44381   clinical trials with a EudraCT protocol, of which   7393   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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    87 result(s) found for: Haemophilia B With Inhibitors. Displaying page 5 of 5.
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    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
    EudraCT Number: 2014-005401-20 Sponsor Protocol Number: CSLCT-BIO-03-97 Start Date*: 2015-01-30
    Sponsor Name:CSL Limited
    Full Title: An Open-label, Multi-centre Study to Assess the Efficacy and Safety of Biostate® in Patients With von Willebrand's Disease (VWD)
    Medical condition: Von Willebrand's disease (VWD)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-017753-34 Sponsor Protocol Number: CSLCT-BIO-08-52 Start Date*: 2010-07-09
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase III Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy, and Safety of Biostate® in Paediatric Subjects with von Willebrand Disease.
    Medical condition: Von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2009-017301-11 Sponsor Protocol Number: CSLCT-BIO-09-64 Start Date*: 2010-09-20
    Sponsor Name:CSL Behring GmbH
    Full Title: An Open-Label, Multi-Centre Extension Study to Assess the Efficacy and Safety of Biostate® in Paediatric, Adolescent, and Adult Subjects with Von Willebrand Disease who Completed Clinical Studies C...
    Medical condition: Von Willebrand's Disease
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) PL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-000720-16 Sponsor Protocol Number: 3082B2-310-WW Start Date*: 2005-06-22
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals, Inc.
    Full Title: A Randomised, Two-way, Blinded, Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) with a Full-Length Recombinant Factor VIII...
    Medical condition: For all patients participating in the trial:Male subjects with severe or moderately severe hemophilia A (FVIII:C ≤ 2%) previously treated with ≥ 150 exposure days to any Factor VIII product.For pat...
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: HU (Completed) ES (Completed) DE (Completed) SE (Completed) FI (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-003453-16 Sponsor Protocol Number: SHP677-304 Start Date*: 2019-07-31
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD)
    Medical condition: severe von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) DE (Completed) ES (Completed) AT (Completed) IT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-003304-13 Sponsor Protocol Number: TAK-577-3001 Start Date*: Information not available in EudraCT
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis with rVWF in Children Diagnosed With Severe von Willebrand disease
    Medical condition: severe von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IE (Trial now transitioned) NO (Completed) SE (Prematurely Ended) ES (Trial now transitioned) FR (Trial now transitioned) AT (Prematurely Ended) NL (Ongoing) IT (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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