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Clinical trials for Coagulation factor IX

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    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).

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    71 result(s) found for: Coagulation factor IX. Displaying page 1 of 4.
    1  2  3  4  Next»
    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: 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: 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: 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: 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: 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: 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
    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: 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: 2012-005489-37 Sponsor Protocol Number: CSL654_3003 Start Date*: 2014-07-11
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase 3b Open-label, Multicenter, Safety and Efficacy Extension 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
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed) IT (Completed) CZ (Completed) BG (Completed) ES (Completed) AT (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: 2007-004017-33 Sponsor Protocol Number: 3090X1-4405 Start Date*: 2008-04-17
    Sponsor Name:Wyeth Pharmaceuticals France
    Full Title: Reformulated BeneFIX efficacy and safety after conversion from a pdFIX.
    Medical condition: Hemophilia B
    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: FR (Completed)
    Trial results: View results
    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: 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: 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: 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: 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: 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
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