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Clinical trials for Safety Factor

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    2,029 result(s) found for: Safety Factor. Displaying page 1 of 102.
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    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: 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: 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: 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: 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: 2009-011145-18 Sponsor Protocol Number: TEN01 Start Date*: 2009-11-02
    Sponsor Name:Bio Products Laboratory Ltd
    Full Title: A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency
    Medical condition: Factor X deficiency
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10052474 Factor X deficiency PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (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: 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: 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: 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: 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: 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: 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: 2016-003821-40 Sponsor Protocol Number: NN7170-4345 Start Date*: 2017-02-15
    Sponsor Name:Novo Nordisk A/S
    Full Title: Evaluation of safety following Immune Tolerance Induction treatment with turoctocog alfa in patients with haemophilia A following inhibitor development in NN7170-4213 trial
    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: GB (Completed) AT (Completed) BG (Completed) DE (Completed)
    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: 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: 2010-020224-22 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: 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: 2008-002456-24 Sponsor Protocol Number: 3082B2-4418 Start Date*: 2015-04-10
    Sponsor Name:Wyeth Research
    Full Title: A Post Authorization Safety Surveillance Study of Xyntha in Usual Care Settings
    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 Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-001556-35 Sponsor Protocol Number: GENA-21 Start Date*: 2013-07-26
    Sponsor Name:Octapharma AG
    Full Title: Prospective, open-label, multicentre phase 3b study to assess the efficacy and safety of individually tailored prophylaxis with Human-cl rhFVIII in previously treated adult patients with severe hae...
    Medical condition: Severe haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) SK (Completed) CZ (Completed) HU (Completed) BG (Completed) AT (Completed) ES (Prematurely Ended) DE (Completed) PL (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
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