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Clinical trials for Hypofibrinogenemia

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    15 result(s) found for: Hypofibrinogenemia. 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: 2020-005242-41 Sponsor Protocol Number: RF-2019-12370834 Start Date*: 2021-02-12
    Sponsor Name:AZIENDA USL DI BOLOGNA
    Full Title: FIBRINOGEN REPLACEMENT TO PREVENT INTRACRANIAL HAEMORRHAGE IN ISCHEMIC STROKE PATIENTS AFTER THROMBOLYSIS: A PILOT PROBE RANDOMIZED CONTROLLED TRIAL
    Medical condition: Ischemic stroke patients with secondary post-rtPA hypofibrinogenemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10007948 Central nervous system haemorrhages and cerebrovascular accidents HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    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: 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: View results
    EudraCT Number: 2006-002391-17 Sponsor Protocol Number: HLH-2004 Start Date*: 2005-03-10
    Sponsor Name:AZIENDA DI RILIEVO NAZIONALE E DI ALTA SPECIALIZZAZIONE OSPEDALE CIVICO E BENFRATELLI, G.DI CRISTINA E M.ASCOLI
    Full Title: Treatment protocol of the second international study for hemophagoocytic lymphohistiocytosis (HLH)
    Medical condition: Hemophagocytic lymphohistiocytosis (HLH)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10049646 Lymphohistiocytosis PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    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: 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: 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: 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: 2021-000407-20 Sponsor Protocol Number: APHP201454 Start Date*: 2021-09-22
    Sponsor Name:ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
    Full Title: Treatment of nonsevere sporadic Hemophagocytosis Lymphohistiocytosis (HLHs) with ITACITINIB: a phase II prospective trial.
    Medical condition: Adults patients having non severe sporadic Hemophagocytosis Lymphohistiocytosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-006878-23 Sponsor Protocol Number: APHP200023 Start Date*: 2022-08-12
    Sponsor Name:Assistance Publique Hopitaux Paris - APHP
    Full Title: Efficacy of Ruxolitinib as first line treatment in primary haemophagocytic lymphohistiocytosis (HLH) in children: a Phase 2, multicentre, non-comparative study R-HLH
    Medical condition: • Patient with Haemophagocytic lymphohistiocytosis (HLH) or lymphohistiocytic syndrome
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-003632-23 Sponsor Protocol Number: NI-0501-04 Start Date*: 2016-02-24
    Sponsor Name:NovImmune SA
    Full Title: A Phase 2/3, Open-label, Single Arm, Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Multiple Administrations of NI-0501, an Anti-interferon Gamma (An...
    Medical condition: Haemophagocytic lymphohistiocytosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) AT (Completed) CZ (Completed) DE (Completed) ES (Prematurely Ended) SE (Completed)
    Trial results: View results
    EudraCT Number: 2017-003114-10 Sponsor Protocol Number: NI-0501-09 Start Date*: 2018-09-06
    Sponsor Name:Swedish Orphan Biovitrum AG
    Full Title: An Open-label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and to Assess its Efficacy, Safety, Impact on Quality of Life...
    Medical condition: Primary Hemophagocytic Lymphohistiocytosis (pHLH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021428 - Immune system disorders 10071583 Haemophagocytic lymphohistiocytosis PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (GB - no longer in EU/EEA) IT (Completed) SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-001387-20 Sponsor Protocol Number: ELA026-CP002 Start Date*: 2021-10-11
    Sponsor Name:Electra Therapeutics, Inc.
    Full Title: A Phase 1b, Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of ELA026 in Adults and Adolescents with Secondary Hemophagocytic Lymph...
    Medical condition: sHLH is a rare and life-threatening inflammatory syndrome characterized by dysregulated immune function. The disease is associated with a massive systemic inflammatory response for which patients r...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10021428 Immune system disorders SOC
    21.1 10018065 - General disorders and administration site conditions 10058092 Multi-organ disorder PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-000177-25 Sponsor Protocol Number: ATA129-EBV-205 Start Date*: 2021-01-04
    Sponsor Name:Atara Biotherapeutics, Inc.
    Full Title: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases
    Medical condition: • EBV+ primary imunodeficiency lymphoproliferative disease (LPD) • EBV+ LPD in the setting of acquired (non-congenital) immunodeficiency • EBV+ post-transplant LPD involving the central nervous ...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068349 Epstein-Barr virus associated lymphoproliferative disorder PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
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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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