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 3 of 5.
    « Previous 1  2  3  4  5  Next»
    EudraCT Number: 2012-005489-37 Sponsor Protocol Number: CSL654_3003 Start Date*: 2014-07-11
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase 3b Open-label, Multicenter, Safety and Efficacy Extension Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects with Hemophilia B
    Medical condition: Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed) IT (Completed) CZ (Completed) BG (Completed) ES (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2012-002554-23 Sponsor Protocol Number: GENA-05 Start Date*: 2013-02-19
    Sponsor Name:OCTAPHARMA AG
    Full Title: Immunogenicity, Efficacy and Safety of Treatment with Human-cl rhFVIII in Previously Untreated Patients with Severe Haemophilia A
    Medical condition: Severe Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) PL (Completed) DE (Completed) ES (Completed) FR (Completed) PT (Completed) SI (Completed) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-004305-40 Sponsor Protocol Number: CSL222-3001 Start Date*: 2018-10-12
    Sponsor Name:CSL Behring LLC
    Full Title: Phase III, open-label, single-dose, multi-center multinational trial investigating a serotype 5 adeno-associated viral vector containing the Padua variant of a codon-optimized human factor IX gene ...
    Medical condition: Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DK (Trial now transitioned) GB (GB - no longer in EU/EEA) IE (Trial now transitioned) NL (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) SE (Trial now transitioned) IT (Completed)
    Trial results: (No results available)
    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)
    EudraCT Number: 2015-002866-21 Sponsor Protocol Number: BH29884 Start Date*: 2016-01-11
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PROPHYLACTIC EMICIZUMAB VERSUS NO PROPHYLAXIS IN HEMOPHILIA A PATIENTS ...
    Medical condition: Hemophilia A with Inhibitors
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10060612 Hemophilia A LLT
    19.1 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (GB - no longer in EU/EEA) PL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-003324-67 Sponsor Protocol Number: BAY_1093884/19580 Start Date*: 2018-06-22
    Sponsor Name:Bayer AG
    Full Title: Multiple escalating dose study of BAY 1093884 in adults with hemophilia A or B with or without inhibitors
    Medical condition: Hemophilia A or B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    20.0 100000004850 10053752 Hemophilia B with anti factor IX LLT
    20.1 100000004850 10053754 Hemophilia B without inhibitors LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Prematurely Ended) AT (Prematurely Ended) BG (Prematurely Ended) FR (Completed) HU (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-008435-29 Sponsor Protocol Number: 3082B2-4433-WW Start Date*: Information not available in EudraCT
    Sponsor Name:Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company
    Full Title: A Non-Randomized, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of ReFacto AF in Previously Treated Pediatric Subjects Less Than Twelve Years of Age With Severe Hemophilia...
    Medical condition: Severe hemophilia A (FVIII:C <1%) in male subjects <12 years of age.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10018937 Haemophilia A LLT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: FR (Completed) ES (Completed) IT (Completed) GR (Completed) CZ (Completed) SE (Completed) DK (Completed) FI (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2009-016720-31 Sponsor Protocol Number: 250901 Start Date*: 2010-06-09
    Sponsor Name:Baxter Innovations GmbH [...]
    1. Baxter Innovations GmbH
    2. Baxter Healthcare Corporation
    Full Title: BAX 326 (recombinant Factor IX): A Phase 1/3 Prospective, Controlled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety, Immunogenicity in Previously Treated Patients with Severe (FIX...
    Medical condition: Previously treated patients with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) CZ (Completed) ES (Completed) BG (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2015-005521-39 Sponsor Protocol Number: 241502 Start Date*: 2016-06-20
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A Phase 3, Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (BAX 802) in Subjects with Congenital Hemophilia A with Factor VI...
    Medical condition: Congenital Haemophilia A with Factor VIII Inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Prematurely Ended) NL (Prematurely Ended) PL (Prematurely Ended) DE (Prematurely Ended) NO (Prematurely Ended) BG (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-001899-18 Sponsor Protocol Number: OBI-1-302 Start Date*: 2011-10-25
    Sponsor Name:Baxter Innovations GmbH
    Full Title: Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Patients with Congenital Hemophilia A With Factor VIII Inhibitors
    Medical condition: Congenital Hemophilia A with factor VIII inhibitors
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-001255-31 Sponsor Protocol Number: B7841003 Start Date*: 2018-03-28
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS PF-06741086 IN SUBJECTS WITH SEVERE HEMOPHILIA
    Medical condition: Severe Hemophilia A or B, with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    20.1 100000004850 10053754 Hemophilia B without inhibitors LLT
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    20.0 100000004850 10053752 Hemophilia B with anti factor IX LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: PL (Completed) ES (Prematurely Ended) BG (Prematurely Ended) HR (Completed)
    Trial results: View results
    EudraCT Number: 2010-024190-39 Sponsor Protocol Number: IB1001-02 Start Date*: 2011-06-20
    Sponsor Name:Aptevo Europe Limited
    Full Title: Study of Recombinant Factor IX Product, IB1001, in Previously Treated Pediatric Subjects with Hemophilia B
    Medical condition: Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-002333-34 Sponsor Protocol Number: CSL654_3004 Start Date*: 2024-05-01
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase 3, Open-label, Multicenter, Pharmacokinetics, Efficacy, and Safety Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Chinese Su...
    Medical condition: Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2013-003997-28 Sponsor Protocol Number: GENA-15 Start Date*: 2014-01-15
    Sponsor Name:Octapharma Pharmazeutika Produktions GmbH,
    Full Title: Extension Study for Patients who completed GENA-05 (NuProtect) – to Investigate Immunogenicity, Efficacy and Safety of Treatment with Human-cl rhFVIII
    Medical condition: Severe Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: GB (Completed) DE (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-003629-27 Sponsor Protocol Number: 998HB303 Start Date*: 2014-05-20
    Sponsor Name:Bioverativ Therapeutics Inc.
    Full Title: An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc; BIIB029) in the Prevention and Treatment of Bleeding in Previously U...
    Medical condition: Hemophilia B (congenital coagulation factor IX [FIX] deficiency; Christmas disease) is an X-linked bleeding disorder that occurs predominantly in males, characterized by a deficiency of functional ...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10053754 Hemophilia B without inhibitors LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male
    Trial protocol: IE (Completed) GB (Completed) DE (Completed) SE (Completed) BE (Completed) ES (Completed) IT (Completed) DK (Completed) NL (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-005781-39 Sponsor Protocol Number: 091501 Start Date*: 2019-03-25
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A Phase 3b/4, Prospective, Multicenter, Open-label, Randomized, Crossover Study of Tolerability and Safety of FEIBA Reconstituted in Regular or 50% Reduced Volume and of Faster Infusion Rates in Pa...
    Medical condition: Hemophilia A or B with inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2011-002437-19 Sponsor Protocol Number: 251101 Start Date*: 2011-10-28
    Sponsor Name:Baxter Innovations GmbH
    Full Title: BAX326 (RECOMBINANT FACTOR IX): A PHASE 2/3 PROSPECTIVE, UNCONTROLLED, MULTICENTER STUDY EVALUATING PHARMACOKINETICS, EFFICACY, SAFETY, AND IMMUNOGENICITY IN PREVIOUSLY TREATED PEDIATRIC PATIENTS W...
    Medical condition: Pediatric previously treated patients (PTPs) with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2015-001486-67 Sponsor Protocol Number: 101HEMB01 Start Date*: 2016-07-21
    Sponsor Name:Dimension Therapeutics, Inc.
    Full Title: A Phase I/II Open-Label Safety and Dose-Finding Study of Adeno-Associated Virus (AAV) rh10-Mediated Gene Transfer of Human Factor IX in Adults With Moderate/Severe to Severe Hemophilia B
    Medical condition: Moderate/severe to severe hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-000413-39 Sponsor Protocol Number: 251002 Start Date*: 2011-10-06
    Sponsor Name:Baxter Innovations GmbH
    Full Title: BAX 326 (recombinant factor IX): A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients With Severe (FIX level < 1%) or Moderately Severe (FIX level ...
    Medical condition: Previously treated patients with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B undergoing surgical or other invasive procedures
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) SE (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-003075-11 Sponsor Protocol Number: 9HB01EXT Start Date*: 2011-12-05
    Sponsor Name:Biogen Idec Research Ltd
    Full Title: An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant, Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes i...
    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
    19.1 100000004850 10053754 Hemophilia B without inhibitors LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) SE (Completed) PL (Completed) IT (Completed) IE (Completed) NL (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 02:50:53 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA