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Clinical trials for Afibrinogenemia

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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    10 result(s) found for: Afibrinogenemia. Displaying page 1 of 1.
    EudraCT Number: 2011-002419-27 Sponsor Protocol Number: FORMA-02 Start Date*: 2014-06-11
    Sponsor Name:Octapharma AG
    Full Title: Prospective, open-label, uncontrolled, Phase III study to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during and after surgery in ...
    Medical condition: Congenital fibrinogen deficiency.
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10066357 Congenital hypofibrinogenemia LLT
    18.1 100000004850 10066356 Congenital hypofibrinogenaemia LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2011-004154-25 Sponsor Protocol Number: 984 Start Date*: 2013-06-25
    Sponsor Name:Biotest AG
    Full Title: A prospective, open-label, phase I/II study investigating pharmacokinetic properties of BT524 and efficacy and safety of BT524 in the treatment and prophylaxis of bleeding in patients with congenit...
    Medical condition: Patients with congenital afibrinogenemia or severe congenital hypofibrinogenemia.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10016075 Factor I deficiency PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) DE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2007-004088-22 Sponsor Protocol Number: BI 3023_3001 Start Date*: 2009-09-22
    Sponsor Name:CSL BEHRING GmbH
    Full Title: Efficacy and safety of Fibrinogen Concentrate (Human) for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency
    Medical condition: Congenital fibrinogen deficiency ( afibrinogenemia, severe hypofibrinogenemia)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016075 LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-018086-12 Sponsor Protocol Number: BI1412_2009 Start Date*: 2010-08-23
    Sponsor Name:Athena Care/ Isala Klinieken
    Full Title: Efficacy and safety of Haemocomplettan® P in patients experiencing microvascular bleeding while undergoing elective complex cardiac surgery
    Medical condition: Elective complex cardiac surgery is associated with excessive blood loss due to coagulopathy. Fibrinogen concentrate has been shown to reverse dilutional coagulopathy. In this double blinded, place...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10009802 Coagulopathy LLT
    12.1 10000531 Acquired afibrinogenaemia LLT
    12.1 10005517 Blood fibrinogen LLT
    12.1 10011976 Decreased plasma fibrinogen LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-006023-39 Sponsor Protocol Number: BI 3023_2001 Start Date*: 2007-09-24
    Sponsor Name:CSL Behring GmbH
    Full Title: Pharmacokinetics of Haemocomplettan P in subjects with congenital fibrinogen deficiency
    Medical condition: PK study in patient with afibrinogemia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016075 Factor I deficiency LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-001280-30 Sponsor Protocol Number: FGT1-A616 Start Date*: 2007-06-20
    Sponsor Name:LFB SA
    Full Title: INTERNATIONAL NON -CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF FIBRINOGENE T-I IN ADOLESCENTS AND ADULTS WITH AFIBRINOGENAEMIA OR SEVERE HYPOFIBRINOGENAEMIA UNDERGOING SURGERY
    Medical condition: Surgical procedures in patients with afibrinogenaemia and severe hypofibrinogenaemia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052651 Afibrinogenaemia LLT
    9.1 10051125 Hypofibrinogenaemia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-004005-81 Sponsor Protocol Number: GC1801 Start Date*: 2021-01-25
    Sponsor Name:Instituto Grifols, S.A.
    Full Title: A prospective, multicenter, open-label, single-arm study to evaluate the efficacy and safety of human plasma-derived fibrinogen concentrate (FIB Grifols) in subjects with congenital afibrinogenaemi...
    Medical condition: Congenital Afibrinogenaemia and Severe Hypofibrinogenemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10052651 Afibrinogenaemia LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-002403-15 Sponsor Protocol Number: Forma-01 Start Date*: 2012-08-07
    Sponsor Name:OCTAPHARMA AG
    Full Title: A prospective, controlled, randomised, cross-over study investigating the pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/ RiaSTAPTM in subjec...
    Medical condition: congenital fibrinogen deficiency
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004850 10052651 Afibrinogenaemia LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-000261-36 Sponsor Protocol Number: FGTW-1004 Start Date*: 2013-11-29
    Sponsor Name:LFB Biotechnologies
    Full Title: Clinical pharmacology, efficacy and safety study of FGTW in paediatric patients with severe congenital fibrinogen deficiency
    Medical condition: Afibrinogenaemia or severe hypofibrinogenaemia
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10052651 Afibrinogenaemia LLT
    16.1 10005329 - Blood and lymphatic system disorders 10051125 Hypofibrinogenaemia PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-004343-23 Sponsor Protocol Number: IG0902 Start Date*: 2018-03-20
    Sponsor Name:INSTITUTO GRIFOLS, S.A.
    Full Title: Studio per indagare le proprietà farmacocinetiche (per vedere quanto è attivo il farmaco di studio nel sangue e quanto tempo ci vuole per il farmaco di studio per uscire dal sangue), l'efficacia e ...
    Medical condition: Congenital Afibrinogenemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10052651 Afibrinogenaemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    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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