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Clinical trials for Hemophilia

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   44398   clinical trials with a EudraCT protocol, of which   7410   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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    277 result(s) found for: Hemophilia. Displaying page 7 of 14.
    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: 2011-002415-28 Sponsor Protocol Number: CSL654_3001 Start Date*: 2012-01-19
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase II/III Open-label, Multicenter, Safety and Efficacy 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
    16.1 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) AT (Completed) ES (Completed) IT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2014-004155-32 Sponsor Protocol Number: 3090A1-301 Start Date*: 2015-04-06
    Sponsor Name:Wyeth Research
    Full Title: An Open-Label, Single-Arm, Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX ) in Children Less Than 6 Years of Age With Severe Hemophilia B
    Medical condition: Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-006032-23 Sponsor Protocol Number: CSL654_3002 Start Date*: 2012-07-20
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase III Open-label, Multicenter, Pharmacokinetics, Safety, and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Previously Treated Children ...
    Medical condition: Prophylaxis and treatment of bleeding episodes in previously treated children with congenital FIX deficiency (hemophilia B)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: AT (Completed) ES (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000520-15 Sponsor Protocol Number: B1821010 Start Date*: 2011-09-29
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A MULTICENTER, OPEN LABEL STUDY TO COMPARE ON DEMAND TREATMENT TO A PROPHYLAXIS REGIMEN OF NONACOG ALFA (BENEFIX) IN SUBJECTS WITH MODERATELY SEVERE TO SEVERE HEMOPHILIA B (FIX:C ≤2%)
    Medical condition: Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    15.0 10010331 - Congenital, familial and genetic disorders 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: PL (Completed) BG (Completed) GR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-003262-13 Sponsor Protocol Number: CSL627_3001 Start Date*: 2014-09-30
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects with Severe Hemophilia A
    Medical condition: Hemophilia A Severe hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: IT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) CZ (Completed) HU (Completed) ES (Completed) NL (Completed) AT (Completed) PL (Completed) PT (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2009-016719-39 Sponsor Protocol Number: 050901 Start Date*: 2010-04-07
    Sponsor Name:Baxter Innovations GmbH
    Full Title: IMMUNINE – Purified Factor IX Concentrate Virus-Inactivated: A Phase IV, Prospective, Open-label Multicenter Study to Prospectively Document the Exposure of IMMUNINE and to Monitor FIX Inhibitors i...
    Medical condition: To expose up to 50 patients aged 12-64 years, and approximately 20 pediatric patients up to 11 years of age with severe or moderately severe hemophilia B to IMMUNINE for a period of approximately 2...
    Disease: Version SOC Term Classification Code Term Level
    15.0 10010331 - Congenital, familial and genetic disorders 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2026-000042-29 Sponsor Protocol Number: YO39309 Start Date*: 2026-02-12
    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 or without Factor VIII inhibitors
    Disease: Version SOC Term Classification Code Term Level
    28.0 10010331 - Congenital, familial and genetic disorders 10053753 Hemophilia A without inhibitors LLT
    28.0 10010331 - Congenital, familial and genetic disorders 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    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: 2014-004156-65 Sponsor Protocol Number: 3090A1-3305 Start Date*: 2015-04-06
    Sponsor Name:Wyeth Pharmaceutical Co, Ltd.
    Full Title: An Evaluation of the Safety and Efficacy of On-Demand Treatment with BeneFIX (Nonacog Alfa, Recombinant Factor IX) in Chinese Subjects with Hemophilia B
    Medical condition: Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-000465-20 Sponsor Protocol Number: NN7769-4513 Start Date*: 2019-12-16
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple subcutaneous doses of NNC0365-3769 (Mim8) in healthy subjects and in subjects with haemophilia A with or without f...
    Medical condition: Healthy volunteers (Haemophilia A with or without inhibitors) Haemophilia A Haemophilia A with inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) AT (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-018477-38 Sponsor Protocol Number: CSL654_2001 Start Date*: 2010-11-15
    Sponsor Name:CSL Behring GmbH
    Full Title: An Open-label, Multicenter, Dose-Escalation Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects with Hemophilia B.
    Medical condition: Prophylaxis and treatment of bleeding episodes in subjects with congenital Factor IX (FIX) deficiency (Hemophilia B)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed) AT (Completed) ES (Completed) GB (Completed) IT (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-000662-29 Sponsor Protocol Number: 270-203 Start Date*: 2018-02-01
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 1/2 Safety, Tolerability, and Efficacy Study of BMN 270, an Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Residual FVIII Levels ≤ 1...
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-003256-32 Sponsor Protocol Number: MO42245 Start Date*: 2021-04-14
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: AN INTERVENTIONAL OPEN-LABEL MULTICENTER PHASE IV STUDY TO EVALUATE THE IMPACT OF EMICIZUMAB ON HEALTH-RELATED QUALITY OF LIFE, PHYSICAL ACTIVITY, AND JOINT HEALTH IN PATIENTS WITH SEVERE HEMOPHILI...
    Medical condition: Severe hemophilia A without factor VIII inhibitors
    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: SE (Completed) NO (Completed) FI (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2019-004480-48 Sponsor Protocol Number: 20446 Start Date*: 2021-12-14
    Sponsor Name:Bayer AG
    Full Title: A prospective, lead-in study to collect bleeding episodes, Factor VIII (FVIII) infusions, and patient-reported outcomes in patients with hemophilia A
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: ES (Prematurely Ended) NL (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: 2017-003573-34 Sponsor Protocol Number: 270-302 Start Date*: 2018-02-23
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII at a dose of 4E13 vg/kg in Hemoph...
    Medical condition: Haemophilia A
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Prematurely Ended) FR (Completed) BE (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-003086-33 Sponsor Protocol Number: C0371002 Start Date*: 2020-01-28
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: Phase 3, open label, single arm study to evaluate efficacy and safety of FIX gene transfer with PF-06838435 (rAAV-Spark100-hFIX-Padua) in adult male participants with moderately severe to severe he...
    Medical condition: severe to moderately severe hemophilia B <=2%
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned) DE (Trial now transitioned) GR (Trial now transitioned)
    Trial results: (No results available)
    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: 2004-002648-88 Sponsor Protocol Number: 3090A-101795 Start Date*: 2005-11-17
    Sponsor Name:Wyeth Pharmaceuticals
    Full Title: In vitro evaluation of allergic reactions in hemophilia B subjects who have exhibited a systemic allergic response after exposure to BeneFIX (Nonacog Alfa; recombinant Factor IX)
    Medical condition: Hemophilia B
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) FR (Completed)
    Trial results: (No results available)
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