Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Factor B

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   44341   clinical trials with a EudraCT protocol, of which   7370   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    1,171 result(s) found for: Factor B. Displaying page 1 of 59.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2013-004779-11 Sponsor Protocol Number: RB-FVIIa-006-13 Start Date*: 2014-07-03
    Sponsor Name:rEVO Biologics, Inc.
    Full Title: A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients with Inhibitors to Factor VIII or IX
    Medical condition: Congenital haemophilia A or B patients with inhitors to Factor VIII or Factor IX
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    18.0 100000004850 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) BG (Completed) RO (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-001464-11 Sponsor Protocol Number: ALN-AT3SC-004 Start Date*: Information not available in EudraCT
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: ATLAS-A/B: A Phase 3 study to evaluate the efficacy and safety of fitusiran in patients with hemophilia A or B, without inhibitory antibodies to factor VIII or IX
    Medical condition: Hemophilia A or Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000011915 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000011913 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: IE (Prematurely Ended) BG (Completed) HU (Completed) ES (Prematurely Ended) PT (Completed) FR (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) NL (Not Authorised) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-010387-41 Sponsor Protocol Number: BI71023_2002 Start Date*: 2009-06-25
    Sponsor Name:CSL Behring LLC
    Full Title: A 12-week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congential Factor XIII Deficiency Estudio de 12 semanas, multicéntrico, de...
    Medical condition: Congenital Factor XIII deficiency Deficiencia congénita de factor XIII
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016083 Factor XIII deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-000765-22 Sponsor Protocol Number: B1821052 Start Date*: 2017-01-11
    Sponsor Name:Pfizer, Inc.
    Full Title: An Open-label, Single-arm, Post-authorization Pragmatic Clinical Trial On The Safety And Efficacy Of Benefix (nonacog Alfa, Recombinant Factor IX) In Subjects With Hemophilia B In Usual Care Settin...
    Medical condition: Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001463-36 Sponsor Protocol Number: EFC14768 Start Date*: 2018-07-25
    Sponsor Name:Genzyme Corporation
    Full Title: ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX
    Medical condition: Hemophilia A or Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) BG (Completed) HU (Completed) ES (Prematurely Ended) PT (Completed) FR (Completed) DE (Completed) DK (Completed) NL (Not Authorised) IT (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-002037-67 Sponsor Protocol Number: IG404/1 Start Date*: 2008-08-15
    Sponsor Name:Grifols Biologicals Inc.
    Full Title: EFFICACY AND SAFETY OF FACTOR IX (FIX) CONTAINED IN ALPHANINE® AND ITS PHARMACOKINETIC COMPARISON WITH BENEFIX® IN PATIENTS WITH SEVERE HEREDITARY HAEMOPHILIA B (Follow-up study of the trial IG404...
    Medical condition: HEREDITARY HAEMOPHILIA B One single pharmacokinetic to compare the pharmacokinetic profile of BeneFIX with that of AlphaNine used by the same patients in a previous trial.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adults Gender: Male
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-004087-19 Sponsor Protocol Number: ALN-AT3SC-009 Start Date*: 2017-08-25
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: ATLAS-PPX trial: an open-label, multinational, switching study to describe the efficacy and safety of fitusiran prophylaxis in hemophilia A and B patients previously receiving factor or bypassing a...
    Medical condition: Hemophilia A or Hemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000011915 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000011913 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: ES (Prematurely Ended) IE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) NL (Not Authorised) IT (Completed) 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: 2008-006424-54 Sponsor Protocol Number: NN7128-1907 Start Date*: 2009-06-23
    Sponsor Name:Novo Nordisk A/S
    Full Title: An Exploratory Multi-Centre, Multi-National, Randomised, Double Blinded, Parallel Arm Trial Evaluating Safety, Pharmacokinetics and Dose-finding of prophylactic administration of Long Acting rFVIIa...
    Medical condition: Haemophilia A (Factor VIII) or B with Inhibitors
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018939 Haemophilia B (Factor IX) LLT
    9.1 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: SE (Completed) GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-023069-24 Sponsor Protocol Number: NN7999-3747 Start Date*: Information not available in EudraCT
    Sponsor Name:Novo Nordisk A/S
    Full Title: A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC-0156-0000-0009 when used for Treatment and Prophylaxis of Bleeding Episodes in Patients with Ha...
    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) NL (Completed) DE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-020224-22 Sponsor Protocol Number: PTC124-GD-011-HEM Start Date*: 2010-08-26
    Sponsor Name:PTC Therapeutics, Inc
    Full Title: A Phase 2a Study of Ataluren (PTC124) as an Oral Treatment for Nonsense-Mutation-Mediated Hemophilia A and B
    Medical condition: Nonsense-Mutation-Mediated Hemophilia A and B
    Disease: Version SOC Term Classification Code Term Level
    12.1 10060613 Hemophilia A (Factor VIII) LLT
    12.1 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (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: 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: 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: 2011-000520-15 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: 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: 2016-001885-27 Sponsor Protocol Number: B7841002 Start Date*: 2017-05-09
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A MULTICENTER, OPEN-LABEL, MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF SUBCUTANEOUS OR INTRAVENOUS PF-06741086 IN SUBJECT...
    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
    20.1 100000004850 10053754 Hemophilia B without inhibitors LLT
    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
    Population Age: Adults Gender: Male
    Trial protocol: PL (Completed) ES (Completed) FR (Completed) BG (Completed) HR (Completed)
    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: 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: 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
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed Jun 11 00:14:02 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA