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Clinical trials for Prothrombin

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
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    • 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   43893   clinical trials with a EudraCT protocol, of which   7300   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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    577 result(s) found for: Prothrombin. Displaying page 1 of 29.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2010-019250-41 Sponsor Protocol Number: 220901 Start Date*: 2010-05-27
    Sponsor Name:Baxter Innovations GmbH
    Full Title: AN INTERNATIONAL, MULTI-CENTRE, PROSPECTIVE, OPEN-LABEL, NON-RANDOMISED, UNCONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROTHROMPLEX TOTAL IN ORAL ANTICOAGULANT REVERSAL IN PATIENTS WITH A...
    Medical condition: Acquired Deficiency of Prothrombin Complex Coagulation Factors (II, VII, IX, X) due to oral anticoagulant therapy with Vitamin K antagonists
    Disease: Version SOC Term Classification Code Term Level
    12.1 10037045 Prothrombin deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002204-24 Sponsor Protocol Number: 1160.203 Start Date*: 2014-12-17
    Sponsor Name:University Medical Center Groningen
    Full Title: REVERSAL OF ANTICOAGULANT EFFECT OF DABIGATRAN® BY PROTHROMBIN COMPLEX CONCENTRATE (BERIPLEX®) ASSESSED WITH A NOVEL METHOD OF BLOOD LOSS MEASUREMENT
    Medical condition: Healthy male volunteers. Study assessing the effect of a single 50IU/Kg dose of Beriplex on the anticoagulant effect of Dabigatran. This is of interest when rapid reversal of its effect is mandate...
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002649-41 Sponsor Protocol Number: LEX-209 Start Date*: 2017-06-19
    Sponsor Name:Octapharma Pharmazeutika Produktionsges.m.b.H
    Full Title: A Phase III, randomized, double-blind, multicenter study to assess the efficacy and safety of OCTAPLEX, a four-factor prothrombin complex concentrate (4F-PCC), compared to the 4F-PCC Beriplex® P/N ...
    Medical condition: Reversal of vitamin K antagonist (VKA) induced anticoagulation in patients needing urgent surgery associated with significant bleeding risk.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10065667 Haemorrhage prophylaxis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) PL (Completed) ES (Prematurely Ended) BG (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2016-000309-34 Sponsor Protocol Number: 7654321 Start Date*: 2016-06-10
    Sponsor Name:Medical University of Vienna
    Full Title: Vorapaxar in the human endotoxemia model
    Medical condition: LPS induced acute inflammatory state in healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2006-001217-15 Sponsor Protocol Number: 85/04/04 Start Date*: 2004-09-16
    Sponsor Name:Lassila Riitta
    Full Title: PRO-FEIBA. Asetelma on selkeä etenevä satunnaistettu kaksisuuntainen tutkimus aktivoitujen hyytymistekijöiden (aPCC, activated prothrombin complex concentrate) vaikutuksesta vaikeaa A hemofiliaa sa...
    Medical condition: A-hemofilia
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: FI (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-000392-33 Sponsor Protocol Number: 2014PROPER3 Start Date*: 2015-06-30
    Sponsor Name:University Medical Center Groningen
    Full Title: Fixed versus variable dosing strategy of prothrombin complex concentrate for bleeding complications of vitamin K antagonists
    Medical condition: Major bleeding complications of vitamin K antagonists
    Disease: Version SOC Term Classification Code Term Level
    17.0 10042613 - Surgical and medical procedures 10009678 Clotting factor transfusion PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-004484-31 Sponsor Protocol Number: Riva-PCC Start Date*: 2014-01-10
    Sponsor Name:Medizinische Universität Innsbruck / Allg. u. chirug. Intensivmedizin
    Full Title: Rivaroxaban and PCC: Prothrombin Complex Concentrate in patients with bleeding complications related to Rivaroxaban
    Medical condition: blood coagulation disorder
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004848 10009728 Coagulation and bleeding analyses HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002828-85 Sponsor Protocol Number: RG_15-114 Start Date*: 2017-04-28
    Sponsor Name:University of Birmingham
    Full Title: Paediatric Hepatic International Tumour Trial
    Medical condition: Hepatoblastoma and Hepatocellular Carcinoma.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062001 Hepatoblastoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10019828 Hepatocellular carcinoma non-resectable LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10019830 Hepatocellular carcinoma resectable LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Ongoing) ES (Ongoing) NO (Completed) DE (Ongoing) CZ (Ongoing) BE (Ongoing) FR (Ongoing) NL (Ongoing) PL (Ongoing) AT (Ongoing) SE (Ongoing) FI (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-006870-22 Sponsor Protocol Number: 1144/2022 Start Date*: 2022-11-04
    Sponsor Name:Medical University of Vienna
    Full Title: Substitution of coagulation factors and blood products in patients with liver cirrhosis
    Medical condition: Liver cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10024667 Liver cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-004009-37 Sponsor Protocol Number: MD2021.01 Start Date*: 2021-11-05
    Sponsor Name:Prothya Biosolutions BV
    Full Title: A Phase 1/2 study of the dose-response in pharmacodynamics and safety of prothrombin complex concentrate Cofact in healthy subjects under vitamin K antagonist anticoagulation
    Medical condition: Treatment of bleeding and perioperative prophylaxis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10005103 Bleeding LLT
    21.0 10042613 - Surgical and medical procedures 10036898 Prophylaxis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) CZ (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 100000004851 10009731 Coagulation disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) IT (Ongoing) ES (Ongoing) AT (Ongoing) HR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004528-36 Sponsor Protocol Number: CAC-002-01 Start Date*: 2011-10-06
    Sponsor Name:Asklepion Pharmaceuticals, LLC
    Full Title: An open-label, single center, non-randomized, continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis.
    Medical condition: Patients with inborn errors of bile acid synthesis and metabolism
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10070882 Inborn error in primary bile acid synthesis PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2014-003963-39 Sponsor Protocol Number: CV185-066 Start Date*: 2014-10-02
    Sponsor Name:Bristol-Myers Squibb Company
    Full Title: An In Vitro Comparison of Apixaban Activity in Adult and Pediatric Plasma
    Medical condition: Thrombosis
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004866 10066899 Venous thromboembolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2014-001748-39 Sponsor Protocol Number: PHRC2013-01 Start Date*: 2014-08-21
    Sponsor Name:CHU d'Angers
    Full Title: TRAnexamic Acid for Preventing postpartum hemorrhage following a vaginal delivery : a multicenter randomised, double blind placebo controlled trial
    Medical condition: postpartum hemorrhage
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-002084-20 Sponsor Protocol Number: Version_1.0_MP_and_anticoagulants Start Date*: 2011-07-28
    Sponsor Name:Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie
    Full Title: A prospective, randomized, controlled open-label trial to investigate the effects of 10mg rivaroxaban or 110mg dabigatran on microparticle formation in critically ill patients compared to age-& sex...
    Medical condition: The effect of the used IMPs should be investigated in critically ill patients and healthy subjects
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-001319-71 Sponsor Protocol Number: F1K-MC-EVBQ Start Date*: 2004-08-13
    Sponsor Name:Lilly S.A.
    Full Title: A Phase IIIb Study to Determine Efficacy and Safety of Extended Drotrecogin Alfa (Activated) Therapy in Patients With Persistent Requirement for Vasopressor Support After 96-Hour Infusion With Comm...
    Medical condition: in severe sepsis patients with persistent vasopressordependent hypotension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2019-000285-38 Sponsor Protocol Number: APHP190020 Start Date*: 2019-08-21
    Sponsor Name:London School of Hygiene and Tropical Medicine
    Full Title: Pharmacokinetics of Tranexamic Acid after oral, intramuscular or intravenous administration: a prospective, randomised, cross-over trial in healthy volunteers.
    Medical condition: healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-005796-34 Sponsor Protocol Number: CC-GEMSO-2007 Start Date*: 2008-03-19
    Sponsor Name:Universität Mainz, I. Medizinische Klinik und Poliklinik
    Full Title: A randomized, double-blind, multicenter phase II trial with gemcitabine plus sorafenib versus gemcitabine plus placebo in patients with chemo-naive advanced or metastatic adenocarcinoma of the bili...
    Medical condition: Patients with Adenocarcinoma of the gallbladder or intrahepatic bile ducts or histologically proven hepatic metastases of an earlier resected and histologically proven biliary tract cancer
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008593 Cholangiocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002190-10 Sponsor Protocol Number: UCDCRC/20/03 Start Date*: 2021-02-05
    Sponsor Name:University College Dublin
    Full Title: Coagulopathy of COVID-19: A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation versus Standard Care as a Rapid Response to the COVID-19 Pandemic (RAPID COVID COAG)
    Medical condition: Coagulopathy of COVID-19 appears to afflict approximately 20% of patients with severe COVID-19 and is associated with need for critical care and death. COVID-19 coagulopathy is characterized by ele...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2021-004138-12 Sponsor Protocol Number: TAK-330-3001 Start Date*: 2022-10-25
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Dire...
    Medical condition: Patients on treatment with Factor Xa Inhibitor needing for an urgent intervention associated with a high risk of bleeding.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
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