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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   44334   clinical trials with a EudraCT protocol, of which   7366   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 1 of 15.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2016-002396-99 Sponsor Protocol Number: NN7170-4213 Start Date*: 2016-10-20
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety, tolerability, and pharmacokinetics study of single and multiple subcutaneous doses of turoctocog alfa pegol in patients with haemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: AT (Completed) DE (Completed) BG (Completed) FR (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-001623-38 Sponsor Protocol Number: 060103 Start Date*: 2004-11-05
    Sponsor Name:Baxter AG
    Full Title: Phase 3B Recombinant Antihemophilic Factor Manufactured and Formulated without added Human or Animal Proteins (rAHF-PFM): Evaluation of Immunogenicity, Efficacy, and Safety in Previously Untreated ...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    9.1 10060612 Hemophilia A LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2010-023242-69 Sponsor Protocol Number: GENA-11 Start Date*: 2011-05-31
    Sponsor Name:Octapharma AG
    Full Title: Clinical Study to Investigate the Long-Term Efficacy, Safety, and Immunogenicity of human-cl rhFVIII in Previously Treated Patients with Severe Haemophilia A – Extension Study to GENA-01
    Medical condition: Severe haemophilia A (FVIII:C <1%)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10018937 Haemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-000614-29 Sponsor Protocol Number: NN7415-4255 Start Date*: 2017-06-12
    Sponsor Name:Novo Nordisk A/S
    Full Title: A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients with Severe Haemophilia A without Inhibitors
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Temporarily Halted) DE (Completed) ES (Completed) FR (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-003467-26 Sponsor Protocol Number: NN7769-4516 Start Date*: 2021-11-30
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety, efficacy and exposure of subcutaneously administered NNC0365-3769 (Mim8) prophylaxis in children with haemophilia A with or without FVIII inhibitors
    Medical condition: 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: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) PL (Completed) IT (Completed) ES (Ongoing) PT (Completed) LT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002510-50 Sponsor Protocol Number: Biostate_4001 Start Date*: 2018-03-19
    Sponsor Name:CSL Behring GmbH
    Full Title: A low-interventional Multicentre Post-Authorisation Safety Study for Voncento/Biostate/Aleviate for Routine Prophylaxis, Treatment of Bleeding Events and/or Surgery in Male Subjects with Haemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000011915 10060612 Hemophilia A LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-016383-36 Sponsor Protocol Number: NN7008-3545 Start Date*: 2010-06-15
    Sponsor Name:NOVO NORDISK
    Full Title: A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Previously Treated Paediatric Patients with Haemophilia A
    Medical condition: Following EMEA guidelines NN7008-3545 trial is a prospective clinical phase 3a trial intended at demonstrating safety and efficacy of N8 in previously treated patients < 12 years of age with severe...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10053753 Hemophilia A without inhibitors LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: IT (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2007-004834-18 Sponsor Protocol Number: 060601 Start Date*: 2008-02-22
    Sponsor Name:Baxter Innovations GmbH
    Full Title: PHARMACOKINETIC COMPARISON OF ADVATE rAHF-PFM WITH RECOMBINATE rAHF IN PATIENTS WITH SEVERE HEMOPHILIA A: A PHASE IV, PROSPECTIVE, RANDOMIZED, CONTROLLED, CROSS-OVER, SINGLE CENTER STUDY
    Medical condition: The objective of this study is to further evaluate observations of decreased efficacy in subjects having been switched to Advate rAHF-PFM from Recombinate rAHF by comparing the pharmacokinetic para...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10066439 Hemophilia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-001142-15 Sponsor Protocol Number: NN7088-3859 Start Date*: 2012-05-14
    Sponsor Name:Novo Nordisk A/S
    Full Title: A Multi-national Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC 0129-0000-1003 (N8-GP) when Administered for Treatment and Prophylaxis of Bleeding in Patients with Haemoph...
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10018937 Haemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: NL (Completed) DE (Completed) SE (Completed) NO (Completed) DK (Completed) ES (Completed) GB (Completed) HU (Completed) IT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2008-001104-23 Sponsor Protocol Number: CSLCT-BIO-07-47 Start Date*: 2009-01-22
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase II, multicentre, double-blinded, randomised, cross-over study to evaluate efficacy, safety and pharmacokinetics of Biostate® in subjects with Haemophilia A.
    Medical condition: Haemophilia A - a hereditary bleeding disorder characterised by a deficiency in the plasma protein known as coagulation Factor VIII (FVIII).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2008-002157-21 Sponsor Protocol Number: NN7008-3522 Start Date*: 2009-04-06
    Sponsor Name:NOVO NORDISK
    Full Title: A Multi-Centre, Multi-National, Open-Label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate in Subjects with Haemophilia A
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    12.0 10018937 Haemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-005040-33 Sponsor Protocol Number: B1831083 Start Date*: 2016-12-14
    Sponsor Name:Pfizer, Inc.
    Full Title: An Open-label, Single-arm, Post- Authorization Pragmatic Clinical Trial On The Safety And Efficacy Of Xyntha (moroctocog-alfa (af-cc), Recombinant FVIII) In Subjects With Hemophilia A In Usual Care...
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10018937 Haemophilia A LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002281-46 Sponsor Protocol Number: NN7008-4304 Start Date*: 2018-02-20
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety of turoctocog alfa for prophylaxis and treatment of bleeding episodes in previously treated patients with moderate or severe Haemophilia A in India.
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-004791-35 Sponsor Protocol Number: NN7008-4028 Start Date*: 2018-03-09
    Sponsor Name:Novo Nordisk A/S’
    Full Title: Efficacy and safety of turoctocog alfa for prophylaxis and treatment of bleeding episodes in previously treated Chinese patients with haemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-023666-46 Sponsor Protocol Number: F8VR-1006 Start Date*: 2011-12-13
    Sponsor Name:LFB BIOTECHNOLOGIES
    Full Title: EFFICACY AND SAFETY STUDY OF FACTANE 200 IU/ml ADMINISTERED BY CONTINUOUS INFUSION IN SEVERE HAEMOPHILIA A PATIENTS DURING MAJOR SURGICAL PROCEDURES
    Medical condition: HAEMOPHILIA A
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-023921-39 Sponsor Protocol Number: NN7008-3893 Start Date*: 2011-04-27
    Sponsor Name:Novo Nordisk A/S
    Full Title: Multi-Centre, Open-Label, Randomised Trial Investigating the Pharmacokinetics of a Single Dose of NNC 0155-0000-0004 (N8) in Patients with Haemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    12.1 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-001033-16 Sponsor Protocol Number: NN7008-3809 Start Date*: Information not available in EudraCT
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety and Efficacy of NNC 0155-0000-0004 in Prevention and Treatment of Bleeds in Paediatric Previously Untreated Patients with Haemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10018937 Haemophilia A LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: GB (Prematurely Ended) AT (Completed) ES (Completed) GR (Completed) DK (Completed) HU (Completed) LT (Completed) PL (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2013-004025-88 Sponsor Protocol Number: NN7088-3908 Start Date*: 2014-04-28
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety and Efficacy of turoctocog alfa pegol (N8-GP) in Previously Untreated Patients with Haemophilia A An open-label single-arm multicentre non-controlled phase 3a trial investigating safety a...
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: DE (Completed) AT (Completed) ES (Temporarily Halted) PT (Ongoing) GR (Completed) BG (Completed) RO (Ongoing) IT (Completed) FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2013-003240-23 Sponsor Protocol Number: 967908487 Start Date*: 2013-12-09
    Sponsor Name:St. James' Hospital
    Full Title: PERSONALising Factor VIII prophylaxis regimens: Efficacy of standard versus pharmacokinetically based regimens in adult patients with severe Haemophilia A (PERSONAL trial)
    Medical condition: Severe Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10018937 Haemophilia A LLT
    Population Age: Adults Gender: Male
    Trial protocol: IE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-005945-46 Sponsor Protocol Number: NN7008-3568 Start Date*: 2010-01-18
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects with Haemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10018937 Haemophilia A LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed) ES (Completed) IT (Completed) GB (Completed) PL (Completed) LT (Completed) LV (Completed)
    Trial results: View results
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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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