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Clinical trials for Coagulopathies

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   44347   clinical trials with a EudraCT protocol, of which   7375   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: Coagulopathies. Displaying page 1 of 1.
    EudraCT Number: 2021-002727-38 Sponsor Protocol Number: OMS721-HCT-002 Start Date*: Information not available in EudraCT
    Sponsor Name:Omeros Corporation
    Full Title: A Phase 2 Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Narsoplimab in Paediatric Patients (28 Days to 18 Y.O.) with High Risk Haematopoietic Stem Cell Transplant...
    Medical condition: Thrombotic microangiopathies following haematopoietic stem cell transplant
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10064477 Coagulopathies and bleeding diatheses (excl thrombocytopenic) HLGT
    20.0 10005329 - Blood and lymphatic system disorders 10043645 Thrombotic microangiopathy PT
    20.0 10005329 - Blood and lymphatic system disorders 10053567 Coagulopathies HLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) HU (Completed) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-002873-35 Sponsor Protocol Number: LEO 90010-I21 Start Date*: 2007-04-24
    Sponsor Name:LEO Pharmaceutical Products Ltd A/S (LEO Pharma A/S)
    Full Title: Exploratory efficacy and safety, pharmacokinetics and dose-finding study of ATryn® (antithrombin alfa) in patients with disseminated intravascular coagulation associated with severe sepsis
    Medical condition: Disseminated intravascular coagulation associated with severe sepsis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013442 Disseminated intravascular coagulation LLT
    9.1 10040047 Sepsis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FR (Prematurely Ended) DE (Prematurely Ended) NL (Prematurely Ended) ES (Completed) DK (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: 2008-001872-54 Sponsor Protocol Number: ARC1779−006 Start Date*: 2009-01-24
    Sponsor Name:Archemix Corp
    Full Title: A Randomized, Double−blind, Placebo−controlled, Clinical Outcome Study of ARC1779 Injection in Patients with Thrombotic Microangiopathy.
    Medical condition: Thrombotic microangiopathy (TMA) disorders
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009731 Coagulation disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) AT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-002035-81 Sponsor Protocol Number: 2-001 Start Date*: 2007-10-22
    Sponsor Name:Artisan Pharma, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects with Sepsis and Disseminated Intravascular Coagulation
    Medical condition: Sepsis and disseminated intravascular coagulation.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10040047 Sepsis LLT
    9.1 10013442 Disseminated intravascular coagulation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) CZ (Completed) BE (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000740-21 Sponsor Protocol Number: LEX-210 Start Date*: 2022-04-08
    Sponsor Name:Octapharma AG
    Full Title: Study of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on direct oral anticoagulant (DOAC) therapy with factor Xa inhibitor.
    Medical condition: Acute major bleeding in patients receiving DOAC therapy with factor Xa inhibitor
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10009731 Coagulation disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) AT (Trial now transitioned) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-005650-54 Sponsor Protocol Number: MD2011.01 Start Date*: 2012-06-04
    Sponsor Name:University Medical Center Groningen
    Full Title: Prothrombin complex concentrate in the reduction of blood loss during otrhotopic liver transplantation.
    Medical condition: liver cirhosis coagulopathy bleeding
    Disease: Version SOC Term Classification Code Term Level
    14.1 10005329 - Blood and lymphatic system disorders 10009802 Coagulopathy PT
    14.1 10042613 - Surgical and medical procedures 10024716 Liver transplantation LLT
    14.1 10022891 - Investigations 10049227 Bleeding time abnormal PT
    14.1 10019805 - Hepatobiliary disorders 10024667 Liver cirrhosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Prematurely Ended) NL (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000246-19 Sponsor Protocol Number: 3-3002 Start Date*: 2018-09-24
    Sponsor Name:Asahi Kasei Pharma America Corporation
    Full Title: SCARLET-2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects with Sepsis and Coagulopathy
    Medical condition: Sepsis, defined by the presence of infection and host inflammation, is a lethal clinical syndrome. In severe disease, the coagulation system becomes diffusely activated, with consumption of multipl...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10053840 Bacterial sepsis PT
    20.0 10005329 - Blood and lymphatic system disorders 10009802 Coagulopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-004726-42 Sponsor Protocol Number: 17/BW/MAT/PO14 Start Date*: 2017-02-15
    Sponsor Name:Birmingham Women's Hospital
    Full Title: Randomised controlled trial on the use of synthetic osmotic cervical dilator in induction of labour in comparison to dinoprostone vaginal insert
    Medical condition: Induction of Labour
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10000154 Abnormal labour affecting foetus PT
    20.0 100000004849 10054386 Fetal heart rate disorder LLT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10046790 Uterine hypertonus PT
    20.0 10005329 - Blood and lymphatic system disorders 10013442 Disseminated intravascular coagulation PT
    20.0 10022117 - Injury, poisoning and procedural complications 10046820 Uterine rupture PT
    20.0 10021428 - Immune system disorders 10002198 Anaphylactic reaction PT
    20.0 100000004872 10018162 Genital oedema female LLT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10001971 Amniotic fluid embolism LLT
    20.0 10017947 - Gastrointestinal disorders 10028816 Nausea and vomiting LLT
    20.0 10017947 - Gastrointestinal disorders 10012735 Diarrhoea PT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10016492 Fetal distress syndrome LLT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2008-007883-41 Sponsor Protocol Number: F13CD-3720(Mentor™2) Start Date*: 2009-08-13
    Sponsor Name:Novo Nordisk A/S
    Full Title: A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency
    Medical condition: Congenital Factor XIII Deficiency
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10061992 Haemophilia PT
    14.1 10010331 - Congenital, familial and genetic disorders 10010432 Congenital deficiency of other clotting factors LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10009735 Coagulation disorders congenital HLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DE (Completed) GB (Completed) FR (Completed) ES (Completed) IT (Completed) AT (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
    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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