Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Fibrinogen

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 ).  
     
    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
     
    300 result(s) found for: Fibrinogen. Displaying page 1 of 15.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2007-000026-44 Sponsor Protocol Number: 2007-04-04 Start Date*: 2007-04-19
    Sponsor Name:Aarhus Universityhospital
    Full Title: Hydroxyethylstarch induced coagulopathy and haemostatic potential of fibrinogen - in vivo placebo controlled clinical trial.
    Medical condition: The present study evaluates dilution coagulopathy induced by hydroxyethyl starch solutions in a clinical setting on patients undergoeing cystektomia due to bladder cancer. Furteher the haemostatic ...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10060906 Dilutional coagulopathy PT
    9.1 10016595 Fibrinogen LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    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: 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: 2006-001543-60 Sponsor Protocol Number: Fibrinogen 2006-1 Start Date*: 2006-08-28
    Sponsor Name:Sahlgrenska Akademin vid Göteborgs Universitet
    Full Title: FIBRINOGEN OCH BLÖDNING EFTER HJÄRTKIRURGI
    Medical condition: Tjugo kranskärlspatienter med låga normalvärden av fibrinogen.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (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: 2011-004154-25 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: 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: 2016-003749-27 Sponsor Protocol Number: FORMA-05 Start Date*: 2016-12-02
    Sponsor Name:Octapharma AG
    Full Title: Prospective, Randomised, Controlled Phase 2 Study Investigating the Haemostatic Efficacy and Safety of Fibrinogen Concentrate (Octafibrin) and Cryoprecipitate as Fibrinogen Supplementation Sources ...
    Medical condition: The sequence of events culminating in Pseudomyxoma peritonei (PMP) is thought to involve growth of an appendiceal adenoma with distension of the appendix by mucus and mucinous tumour cells. The app...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10037138 Pseudomyxoma peritonei PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (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: 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: 2019-002239-27 Sponsor Protocol Number: RAM-LIG-2019-01 Start Date*: 2019-09-24
    Sponsor Name:Clinica Dental AndreuDental
    Full Title: Study on the relationship between periodontal disease and serum levels of ultrasensitive Reactive C-Protein and fibrinogen
    Medical condition: Patients with a diagnosis of periodontitis: There is interdental LCI in two or more non-adjacent teeth, or two or more teeth have a vestibular LCI ≥ 3 with a PD > 3 mm
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    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: 2019-004295-18 Sponsor Protocol Number: 080487 Start Date*: 2019-12-13
    Sponsor Name:Aarhus University Hospital
    Full Title: Fibrinogen and platelets in patients with acute myeloid leukaemia and thrombocytopenia
    Medical condition: Bleeding i patients with acute myeloid leukemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10005103 Bleeding LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-004087-22 Sponsor Protocol Number: FiT2012 Start Date*: 2012-12-19
    Sponsor Name:Medizinische Universität Innsbruck / Univ.-Klinik für Allg. und Chirurg. Intensivmedizin
    Full Title: Bicentric clinical trial with in vitro experiments to assess the effect of Fibrinogen (FGTW) on Coagulation in Thrombocytopenia
    Medical condition: Thrombocytopenia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004851 10043555 Thrombocytopenias HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-016709-41 Sponsor Protocol Number: FIB692 Start Date*: 2010-01-26
    Sponsor Name:NHS Lothian [...]
    1. NHS Lothian
    2. University of Edinburgh
    Full Title: Coagulopathy during surgery for the repair of Extent 4 Thoraco-Abdominal Aortic Aneurysms - feasibility study of the use of Fibrinogen Concentrate by infusion in place of Fresh Frozen Plasma.
    Medical condition: Coagulation disturbance during thoracoabdominal aneurysm repair.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-001163-20 Sponsor Protocol Number: 995 Start Date*: 2017-09-25
    Sponsor Name:Biotest AG
    Full Title: A randomized, active-controlled, multicenter, phase III study investigating efficacy and safety of intra-operative use of BT524 (human fibrinogen concentrate) in subjects undergoing major spinal or...
    Medical condition: Elective spinal or abdominal surgery with expected major blood loss
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10051125 Hypofibrinogenaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Ongoing) CZ (Completed) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    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: 2018-002510-13 Sponsor Protocol Number: TROMBOFIBtrial Start Date*: 2018-09-28
    Sponsor Name:Antoni Sabaté Pes (Servicio de Anestesiología y Reanimación) del Hospital Universitari de Bellvitge
    Full Title: Impact of two thrombelastography-guided strategies of fibrinogen correction on blood product requirements in liver transplantation: a multicenter, randomized trial. TROMBOFIB trial
    Medical condition: Liver transplantation is a special risk situation for acute and severe bleeding determined by the complexity of the surgical procedure and by the alteration of haemostasis and coagulation factors, ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10024716 Liver transplantation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-002685-20 Sponsor Protocol Number: BI3023_3002 Start Date*: 2011-11-24
    Sponsor Name:CSL Behring GmbH
    Full Title: REPLACE (Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery): a prospective, multinational, multicenter, randomized, double-blind, placebo-controlled, phase III...
    Medical condition: Acute bleeding while undergoing aortic replacement surgery
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004865 10049052 Aortic surgery NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) FI (Completed) IT (Completed) AT (Completed) CZ (Completed) PL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-005115-16 Sponsor Protocol Number: FORMA-04 Start Date*: 2020-04-22
    Sponsor Name:Octapharma AG
    Full Title: Prospective, open-label, uncontrolled, Phase III study to assess the efficacy, safety, and pharmacokinetics of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during an...
    Medical condition: Congenital fibrinogendeficiency
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    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-Mon May 20 00:57:21 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA