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Clinical trials for hemophilia OR haemophilia

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   44346   clinical trials with a EudraCT protocol, of which   7374   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.
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    283 result(s) found for: hemophilia OR haemophilia. Displaying page 9 of 15.
    EudraCT Number: 2013-003742-16 Sponsor Protocol Number: IB1001-04 Start Date*: 2014-04-29
    Sponsor Name:Cangene Europe Limited
    Full Title: Pharmacokinetics, Safety and Efficacy of Recombinant Factor IX Product, IB1001, in Patients with Severe Hemophilia B
    Medical condition: Severe Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004850 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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: 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: 2015-003027-61 Sponsor Protocol Number: B1821048 Start Date*: 2015-12-23
    Sponsor Name:Pfizer Inc.
    Full Title: An open-label, single dose pharmacokinetic study of BeneFIX (nonacog alfa, recombinant factor IX) in male Chinese subjects with haemophilia B.
    Medical condition: Haemophilia B
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: Outside EU/EEA
    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: 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: 2016-001094-33 Sponsor Protocol Number: BO39182 Start Date*: 2016-08-08
    Sponsor Name:Roche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd.
    Full Title: A MULTICENTER, OPEN-LABEL, PHASE III STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF EMICIZUMAB GIVEN EVERY 4 WEEKS (Q4W) IN PATIENTS WITH HEMOPHILIA A
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    19.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Temporarily Halted) PL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2017-004805-42 Sponsor Protocol Number: SB-FIX-1501 Start Date*: 2018-06-05
    Sponsor Name:Sangamo Therapeutics, Inc.
    Full Title: A Phase I, Open-Label, Ascending Dose Study to Assess the Safety and Tolerability of AAV2/6 Factor IX Gene Therapy via Zinc Finger Nuclease (ZFN) mediated targeted integration of SB-FIX in Subjects...
    Medical condition: Severe Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    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: 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: 2011-003539-68 Sponsor Protocol Number: 2011/090/HP Start Date*: 2012-02-09
    Sponsor Name:CHU-HOPITAUX DE ROUEN
    Full Title: ETUDE PROSPECTIVE RANDOMISEE COMPARATIVE PREDNISONE/ CYCLOPHOSPHAMIDE VERSUS PREDNISONE/ RITUXIMAB AU COURS DE L'HEMOPHILIE ACQUISE
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    14.1 10005329 - Blood and lymphatic system disorders 10053745 Acquired haemophilia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    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: 2011-006294-26 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: 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: 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: 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: 2011-002437-19 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: 2015-001919-13 Sponsor Protocol Number: NN1731-4214 Start Date*: 2016-03-17
    Sponsor Name:Novo Nordisk A/S
    Full Title: Pharmacogenetic testing of saliva samples from patients with ≥5 exposure days to rFVIIa analogue in the adept™2 trial. Bio-specimen research study
    Medical condition: - Haemophilia A with inhibitors - Haemophilia B with inhibitors
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10056492 Haemophilia A with anti factor VIII PT
    18.1 10010331 - Congenital, familial and genetic disorders 10056494 Haemophilia B with anti factor IX PT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: RO (Completed)
    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: 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
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