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Clinical trials for Prothrombin complex concentrate

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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

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    23 result(s) found for: Prothrombin complex concentrate. Displaying page 1 of 2.
    1  2  Next»
    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: 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: 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 (Completed)
    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 - A pilot study
    Medical condition: Liver cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10024667 Liver cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-004138-12 Sponsor Protocol Number: TAK-330-3001 Start Date*: 2022-04-11
    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 PROTHROMPLEX TOTAL for the Rever...
    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: FR (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned) NL (Trial now transitioned) ES (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: 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: 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: 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: 2009-015086-31 Sponsor Protocol Number: Ten03 Start Date*: 2010-03-16
    Sponsor Name:Bio Products Laboratory Limited
    Full Title: Ten03: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL’s High Purity Factor X in the treatment of the Factor X Deficient Subjects Undergoing Surgery
    Medical condition: Factor X Deficiency
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003041-41 Sponsor Protocol Number: 012507 Start Date*: 2018-11-16
    Sponsor Name:Queen Mary University of London
    Full Title: A pragmatic pilot randomised controlled trial of Prothrombin Complex Concentrate (PCC) versus Fresh Frozen Plasma (FFP) in adult patients who are undergoing Heart Surgery
    Medical condition: Major bleeding during cardiac surgery not related to vitamin K antagonists
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004863 10051536 Intraoperative bleeding LLT
    20.1 100000004863 10036277 Postoperative bleeding LLT
    21.1 10042613 - Surgical and medical procedures 10042609 Surgery PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-007853-30 Sponsor Protocol Number: sNN0031-001 Start Date*: 2009-01-28
    Sponsor Name:NeuroNova AB
    Full Title: A randomized, double-blind, placebo controlled, safety and tolerability study of intracerebroventricular administration of sNN0031 to patients with idiopathic Parkinson's disease (PD) of moderate s...
    Medical condition: Idiopathic Parkinson's disease (PD) of moderate severity (modified Hoehn & Yahr Stage IIb - III)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-011145-18 Sponsor Protocol Number: TEN01 Start Date*: 2009-11-02
    Sponsor Name:Bio Products Laboratory Ltd
    Full Title: A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency
    Medical condition: Factor X deficiency
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10052474 Factor X deficiency PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-002189-34 Sponsor Protocol Number: HLX11-BC301 Start Date*: 2022-10-26
    Sponsor Name:Shanghai Henlius Biotech, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy o...
    Medical condition: HER2-Positive and HR-Negative Early-stage or Locally advanced Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER2 positive breast cancer PT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10083232 HER2 negative breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) BG (Prematurely Ended) HU (Prematurely Ended) PL (Prematurely Ended) CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-002037-67 Sponsor Protocol Number: IG404/1 Start Date*: 2008-08-15
    Sponsor Name:Grifols Biologicals Inc.
    Full Title: EFFICACY AND SAFETY OF FACTOR IX (FIX) CONTAINED IN ALPHANINE® AND ITS PHARMACOKINETIC COMPARISON WITH BENEFIX® IN PATIENTS WITH SEVERE HEREDITARY HAEMOPHILIA B (Follow-up study of the trial IG404...
    Medical condition: HEREDITARY HAEMOPHILIA B One single pharmacokinetic to compare the pharmacokinetic profile of BeneFIX with that of AlphaNine used by the same patients in a previous trial.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adults Gender: Male
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2019-004118-33 Sponsor Protocol Number: PATCH_Trauma Start Date*: 2020-11-03
    Sponsor Name:Universität Witten/Herdecke
    Full Title: A multi-centre randomised, double-blind, placebo-controlled trial of pre-hospital treatment with tranexamic acid for severely injured patients at risk of acute traumatic coagulopathy.
    Medical condition: Trauma patients with risk for acute traumatic Coagulopathy and Hemorrhage
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004863 10044528 Traumatic injury LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-001111-36 Sponsor Protocol Number: CAN04CLIN001 Start Date*: 2018-01-25
    Sponsor Name:Cantargia AB
    Full Title: An open label, dose escalation followed by dose expansion, safety and tolerability trial of CAN04, a fully humanized monoclonal antibody against IL1RAP, in subjects with solid malignant tumors
    Medical condition: Solid malignant tumors, in the following two indications; Non-Small Cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC),
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NO (Completed) DK (Completed) NL (Completed) DE (Completed) AT (Completed) EE (Completed) ES (Ongoing) LT (Completed) LV (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-003076-36 Sponsor Protocol Number: 9HB02PED Start Date*: 2012-05-29
    Sponsor Name:Biogen Idec Research Ltd
    Full Title: Open-label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in the Prevention and Treatment of Bleeding Episodes in...
    Medical condition: The medical condition to be investigated is Hemophilia B, or Christmas disease. Hemophilia B is a deficiency in the clotting FIX and is a recessively inherited coagulation disorder due to an X-chro...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10053754 Hemophilia B without inhibitors LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: GB (Completed) IE (Completed) NL (Completed)
    Trial results: View results
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