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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 ).  
     
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    283 result(s) found for: hemophilia OR haemophilia. Displaying page 7 of 15.
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    EudraCT Number: 2020-002443-38 Sponsor Protocol Number: C0371006 Start Date*: Information not available in EudraCT
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: Phase 3 open-label study to evaluate efficacy, safety, and tolerability of FIX gene transfer with fidanacogene elaparvovec (PF-06838435) in pediatric male participants <18 years of age with moderat...
    Medical condition: moderately severe to severe hemophilia B (FIX:C≤2%)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18 Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Ongoing) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-000679-18 Sponsor Protocol Number: EFC15467 Start Date*: 2019-07-23
    Sponsor Name:Genzyme Corporation
    Full Title: ATLAS-PEDS: An open-label, multinational study of fitusiran prophylaxis in male pediatric subjects aged 1 to less than 12 years with hemophilia A or B
    Medical condition: Hemophilia A or B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10066439 Hemophilia LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: ES (Restarted) Outside EU/EEA IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-000347-29 Sponsor Protocol Number: 060201 Start Date*: 2005-12-22
    Sponsor Name:Baxter AG
    Full Title: ADVATE ANTIHEMOPHILIC FACTOR (RECOMBINANT), PLASMA/ALBUMIN FREE METHOD (ADVATE rAHF PFM): A PHASE 4 STUDY COMPARING TWO PROPHYLACTIC REGIMENS IN SUBJECTS WITH SEVERE OR MODERATELY SEVERE HEMOPHILIA A
    Medical condition: Severe or moderately severe hemophilia A with a residual factor FVIII activity less than or equal 2%
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) HU (Completed) CZ (Completed) SI (Completed) IT (Completed)
    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: 2017-003215-19 Sponsor Protocol Number: 270-301 Start Date*: 2017-11-25
    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 in Hemophilia A Patients with Res...
    Medical condition: Haemophilia A
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Ongoing) FR (Completed) BE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-020558-33 Sponsor Protocol Number: 997HA301 Start Date*: 2011-04-14
    Sponsor Name:Biogen Idec Hemophilia, Inc.
    Full Title: A-LONG: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in ...
    Medical condition: Severe hemophilia A - defined as <1 IU/dL (<1%) endogenous FVIII
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10056493 Haemophilia A without inhibitors PT
    14.1 10010331 - Congenital, familial and genetic disorders 10053753 Hemophilia A without inhibitors LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10018937 Haemophilia A LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) GB (Completed) FR (Ongoing) DE (Completed) BE (Completed) ES (Completed) AT (Completed) IT (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000742-30 Sponsor Protocol Number: 261202 Start Date*: 2014-07-14
    Sponsor Name:Baxter Innovations GmbH
    Full Title: A phase 3 prospective, uncontrolled, multicenter study evaluating pharmacokinetics, efficacy, safety, and immunogenicity of BAX 855 (PEGylated full-length Recombinant FVIII) in previously treated p...
    Medical condition: Severe hemophilia A (FVIII<1%)
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) ES (Completed) BG (Completed) RO (Completed) NL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-000826-31 Sponsor Protocol Number: NN7999-3774 Start Date*: 2012-08-24
    Sponsor Name:Novo Nordisk
    Full Title: Safety, Efficacy and Pharmacokinetics of NNC-0156- 0000-0009 (N9-GP) in Previously Treated Children with Haemophilia B
    Medical condition: Haemophilia 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, Adolescents, Under 18 Gender: Male
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) IT (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: 2020-000769-18 Sponsor Protocol Number: EFC16295 Start Date*: Information not available in EudraCT
    Sponsor Name:Bioverativ Therapeutics Inc.
    Full Title: A Phase 3 open-label, multicenter study of the safety, efficacy, and pharmacokinetics of intravenous recombinant coagulation Factor VIII Fc-von Willebrand Factor-XTEN fusion protein (rFVIIIFc-VWF-X...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: DE (Completed) FR (Completed) IE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) SE (Completed) HU (Completed) NL (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-006186-14 Sponsor Protocol Number: KB037 Start Date*: 2007-09-10
    Sponsor Name:KEDRION
    Full Title: Open Label Phase II Evaluation of Pharmacokinetics, Efficacy, and Safety of Kedrion Human Plasma-derived Antihaemophilic Double Virus inactivated and Nanofiltered Factor IX Administered to Previous...
    Medical condition: Severe or Moderately Severe Hemophilia B Patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016077 Factor IX deficiency LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000410-18 Sponsor Protocol Number: 061002 Start Date*: 2011-05-05
    Sponsor Name:Baxter Innovations GmbH
    Full Title: A PHASE 3b CLINICAL STUDY TO ASSESS WHETHER REGULAR ADMINISTRATION OF ADVATE IN THE ABSENCE OF IMMUNOLOGICAL DANGER SIGNALS REDUCES THE INCIDENCE RATE OF INHIBITORS IN PREVIOUSLY UNTREATED PATIENTS...
    Medical condition: Prevention of inhibitor formation, and immune tolerance induction in patients with severe and moderately severe hemophilia A by early and low-dose prophylactic ADVATE therapy
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male
    Trial protocol: AT (Prematurely Ended) DE (Completed) SK (Prematurely Ended) LT (Prematurely Ended) GB (Prematurely Ended) HU (Prematurely Ended) CZ (Prematurely Ended) SE (Prematurely Ended) BE (Prematurely Ended) BG (Completed) ES (Prematurely Ended) NL (Prematurely Ended) GR (Prematurely Ended) PL (Prematurely Ended) PT (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: 2010-023072-17 Sponsor Protocol Number: NN7999-3775 Start Date*: Information not available in EudraCT
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety and Efficacy of NNC-0156-0000-0009 after Long-Term Exposure in Patients with Haemophilia B
    Medical condition: Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    12.1 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: FR (Ongoing) GB (Completed) NL (Completed) DE (Completed) IT (Completed) ES (Completed) AT (Completed) GR (Prematurely Ended)
    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: 2018-004889-34 Sponsor Protocol Number: NN7415-4311 Start Date*: 2019-10-07
    Sponsor Name:Novo Nordisk A/S
    Full Title: Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B with inhibitors
    Medical condition: Haemophilia A with inhibitors Haemophilia B with inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10053751 Hemophilia A with anti factor VIII LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10053752 Hemophilia B with anti factor IX LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DK (Trial now transitioned) SE (Trial now transitioned) AT (Completed) FR (Trial now transitioned) PT (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) SK (Completed) NO (Completed) BG (Completed) CZ (Completed) GB (GB - no longer in EU/EEA) HR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001079-18 Sponsor Protocol Number: FLT180a-06 Start Date*: 2022-04-27
    Sponsor Name:Freeline Therapeutics Ltd
    Full Title: A dose confirmation study of FLT180a (adeno-associated viral vector containing the Padua variant of a codon-optimized human Factor IX gene) in adult subjects with hemophilia B.
    Medical condition: Haemophilia B.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: AT (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
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