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Clinical trials for Hemophilia A AND 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
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    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 ).  
     
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    241 result(s) found for: Hemophilia A AND Haemophilia. Displaying page 6 of 13.
    «« First « Previous 2  3  4  5  6  7  8  9  10  Next» Last»»
    EudraCT Number: 2010-021781-29 Sponsor Protocol Number: BAY81-8973/13400 Start Date*: 2011-07-07
    Sponsor Name:Bayer HealthCare AG
    Full Title: A multicenter Phase III uncontrolled open-label trial to evaluate safety and efficacy of BAY 81-8973 in children with severe haemophilia A under prophylaxis therapy
    Medical condition: Severe Hemophilia-A (< 1% FVIII:C)
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: HU (Completed) LT (Completed) SE (Completed) DK (Completed) IE (Completed) LV (Completed) BG (Completed) IT (Completed) PL (Completed) AT (Completed) ES (Completed) GB (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2017-000373-36 Sponsor Protocol Number: 997HA402 Start Date*: 2017-12-11
    Sponsor Name:Bioverativ Therapeutics Inc.
    Full Title: A Non-controlled, Open-Label, Multicenter, Study of Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Subjects with Inhibitors Undergoing the First ITI Treatment
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000011915 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000011928 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male
    Trial protocol: ES (Completed) DE (Completed) BE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) BG (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-005697-71 Sponsor Protocol Number: 060402 Start Date*: 2006-01-26
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method (rAHF PFM): A Phase 3/4, Prospective, Controlled, Randomized, Multi-Center Study to Compare the Efficacy and Safety of Continuous Infu...
    Medical condition: Subjects with Severe or Moderately Severe Hemophilia A (baseline factor VIII (FVIII) level <= 2% of normal) hemophilia A undergoing major orthopedic surgery
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SE (Completed) BE (Completed) PT (Completed) ES (Completed) HU (Completed) NL (Completed) GB (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-007997-39 Sponsor Protocol Number: B1831004(3082B2-4432-WW) Start Date*: 2009-04-09
    Sponsor Name:Wyeth Pharmaceuticals, Inc. Acting through its division Wyeth Research, a Pfizer Company
    Full Title: A Postauthorization Safety Surveillance Study of Patients Switching to ReFacto AF From ReFacto or Other Factor VIII Products in Usual Care Settings
    Medical condition: Severe haemophilia A (FVIII:C <1%) in male patients ≥12 years of age with a treatment history of >150 EDs to prior recombinant or plasma-derived FVIII replacement products and transitioning to ReFa...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10018937 Haemophilia A LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) SE (Completed) AT (Completed) FI (Completed) DK (Completed) FR (Completed) IT (Completed) PT (Prematurely Ended) NL (Completed) GB (Completed) CZ (Completed) GR (Completed) HU (Completed)
    Trial results: View results
    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: 2020-000739-28 Sponsor Protocol Number: CT-AMT-060-04_(CSL220_1002) Start Date*: 2020-11-19
    Sponsor Name:CSL Behring LLC
    Full Title: A Phase I/IIb extension study assessing the long-term safety and efficacy of an adeno-associated viral vector containing a codon-optimized human factor IX gene (AAV5-hFIX) previously administered t...
    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: DE (Trial now transitioned) DK (Prematurely Ended) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-003073-28 Sponsor Protocol Number: 8HA02PED Start Date*: 2012-05-31
    Sponsor Name:Biogen Idec Research Ltd
    Full Title: An Open-Label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB031, in the Prevention and Treatment of Bleeding Episod...
    Medical condition: Severe Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10053753 Hemophilia A without inhibitors LLT
    14.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: GB (Completed) IE (Completed) NL (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-007883-41 Sponsor Protocol Number: F13CD-3720(Mentor™2) Start Date*: 2009-08-13
    Sponsor Name:Novo Nordisk A/S
    Full Title: A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency
    Medical condition: Congenital Factor XIII Deficiency
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10061992 Haemophilia PT
    14.1 10010331 - Congenital, familial and genetic disorders 10010432 Congenital deficiency of other clotting factors LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10009735 Coagulation disorders congenital HLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DE (Completed) GB (Completed) FR (Completed) ES (Completed) IT (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2013-005579-42 Sponsor Protocol Number: CT-AMT-060-01 Start Date*: 2015-03-20
    Sponsor Name:uniQure biopharma B.V.
    Full Title: A phase I/II, open-label, uncontrolled, single-dose, dose-ascending, multi-centre trial investigating an adeno-associated viral vector containing a codon-optimized human factor IX gene (AAV5-hFIX) ...
    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: DE (Completed) DK (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2013-003013-18 Sponsor Protocol Number: 997HA307 Start Date*: 2014-04-23
    Sponsor Name:Biogen Idec Research Ltd
    Full Title: A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetics of 2 Vial Strengths of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in Previously Treated Subjects With S...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    18.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-003537-11 Sponsor Protocol Number: 19855 Start Date*: 2024-03-14
    Sponsor Name:Bayer Healthcare Company Limited
    Full Title: A Post Approval Commitment study to evaluate the efficacy, safety, and pharmacokinetics of KOVALTRY in Chinese children, adolescents/adults with severe hemophilia A.
    Medical condition: KOVALTRY, indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for: - Routine prophylaxis to reduce the frequency of bleeding episodes - On-demand treatmen...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    20.0 10042613 - Surgical and medical procedures 10071818 Bleeding prophylaxis LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-005246-40 Sponsor Protocol Number: 3090A1-400-WW Start Date*: 2007-01-30
    Sponsor Name:Wyeth Pharmaceuticals Inc. - Global Medical Affairs
    Full Title: A Multicenter, Open-Label Study to Compare On-Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX-R) in subjects with Severe ...
    Medical condition: Male subjects, aged 6 years to 65 years, with a documented history of moderately severe or severe Hemophilia B (FIX:C≤2%) and with a minimum of 12 bleeding episodes, of which 6 must be joint bleeds...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adults Gender: Male
    Trial protocol: HU (Completed) BE (Completed) IT (Completed) DE (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-003599-38 Sponsor Protocol Number: 261201 Start Date*: 2013-09-17
    Sponsor Name:Baxter Innovations GmbH
    Full Title: A Phase 2/3, Multi-Center, Open Label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (BAX 855) Administered for Prophylaxis and Treatment of Bleeding in Previo...
    Medical condition: Severe hemophilia A (FVIII <1%)
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed) GB (Completed) AT (Completed) LT (Completed) CZ (Completed) SE (Completed) ES (Completed) BE (Completed) NL (Completed) BG (Completed) PL (Completed) HU (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2011-002393-23 Sponsor Protocol Number: CSL627_1001 Start Date*: 2012-01-10
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Factor VIII (rFVIII; INN: octocog...
    Medical condition: Hemophilia A.
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) SE (Completed) AT (Completed) IT (Completed) PL (Completed) GB (Completed) ES (Completed) HU (Completed) NL (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2012-004867-38 Sponsor Protocol Number: NN7999-3895 Start Date*: 2015-06-08
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety and Efficacy of nonacog beta pegol (N9-GP) in Previously Untreated Patients with Haemophilia B An open-label single-arm multicentre non-controlled phase 3a trial investigating safety and ...
    Medical condition: Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: DE (Completed) AT (Completed) ES (Ongoing) RO (Ongoing) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-004947-25 Sponsor Protocol Number: NN7999-4670 Start Date*: 2023-07-12
    Sponsor Name:Novo Nordisk A/S
    Full Title: A multi-centre, open-label trial evaluating efficacy, safety and pharmacokinetics of nonacog beta pegol when used for treatment and prophylaxis of bleeding episodes in Chinese patients with haemo...
    Medical condition: 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, Elderly Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-001563-11 Sponsor Protocol Number: GENA-01 Start Date*: 2009-10-22
    Sponsor Name:Octapharma AG
    Full Title: Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of human-cl rhFVIII, a Newly Developed Human Cell-Line Derived Recombinant FVIII Concentrate in Previously Tr...
    Medical condition: Severe hemophilia A (FVIII:C <1%)
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-023070-40 Sponsor Protocol Number: NN7999-3773 Start Date*: Information not available in EudraCT
    Sponsor Name:Novo Nordisk A/S
    Full Title: An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 during Surgical Procedures 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) GR (Prematurely Ended) AT (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: 2004-000219-24 Sponsor Protocol Number: 3082A-101342 Start Date*: 2005-04-28
    Sponsor Name:Wyeth Pharmaceuticals
    Full Title: A multicentre study to describe the immunogenic epitope(s) of factor VIII in previously treated patients with congenital haemophilia A who develop de novo factor VIII inhibitors while receiving fac...
    Medical condition: Haemophilia A is an X-linked recessive clotting disorder in which the clotting factor, factor VIII (FVIII), is deficient or inactive. Patients with low levels of FVIII have an increased tendency t...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) ES (Completed) DE (Prematurely Ended) IT (Completed)
    Trial results: View results
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