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Clinical trials for K Complex

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 ).  
     
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    16 result(s) found for: K Complex. Displaying page 1 of 1.
    EudraCT Number: 2005-001007-18 Sponsor Protocol Number: 2989 Start Date*: 2005-06-03
    Sponsor Name:Royal Victoria Infirmary
    Full Title: Reversal of warfarin anticoagulation with oral vitamin K: towards a better management of over-anticoagulation
    Medical condition: Patients with thromboembolic disorders are anticogulated with warfarin. However excessive over-anticoagulation can increase the patient risk of bleeding. Oral vitamin K is routinely used for revers...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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: 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: 2008-006441-10 Sponsor Protocol Number: 116-02 Start Date*: 2009-06-03
    Sponsor Name:SCIPHARM SáRL
    Full Title: A double blind controlled clinical study to investigate the efficacy and tolerability of subcutaneous Treprostinil sodium in patients with severe non-operable Chronic Thromboembolic Pulmonary Hyper...
    Medical condition: Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) CZ (Completed) SK (Completed) DE (Prematurely Ended)
    Trial results: View results
    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: 2008-005653-37 Sponsor Protocol Number: ICH-VKA Start Date*: 2009-05-29
    Sponsor Name:Universityhospital of Heidelberg
    Full Title: Multicenter, prospective randomized trial on the use of prothrombin complex and fresh frozen plasma in patients with intracerebral hemorrhage related to vitamin K antagonists (VKA)
    Medical condition: Intracerebral hemorrhage (ICH) in patients related to vitamin K antagonists
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10022754 Intracerebral hemorrhage LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Suspended by CA) DK (Prematurely Ended)
    Trial results: View results
    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: 2019-004975-37 Sponsor Protocol Number: LIMIT Start Date*: 2021-09-06
    Sponsor Name:Hamilton Health Sciences through the Population Health Research Institute
    Full Title: Low INR to Minimize bleeding with mechanical valves Trial
    Medical condition: Treatment with a Vitamin K Antagonist due to having a mechanical heart valve.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002531-18 Sponsor Protocol Number: 69HCL16_0062 Start Date*: 2018-10-31
    Sponsor Name:Hospices Civils de Lyon
    Full Title: Topical Everolimus versus placebo for the treatment of facial angiofibromas in patients with tuberous sclerosis complex. A phase II/III, multicentre, randomized, double-blind, placebo-controlled st...
    Medical condition: angiofibromas
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10002429 Angiofibroma PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    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: 2019-000570-33 Sponsor Protocol Number: FAAI2.10.2018 Start Date*: 2019-09-26
    Sponsor Name:FONDAZIONE ARIANNA ANTICOAGULAZIONE
    Full Title: The Jason study: Sulodexide (VESSEL®) for the prevention of recurrent venous thromboembolism in elderly patients after a first episode of venous thrombembolism (VTE)
    Medical condition: Prevention of recurrence after a first episode of VTE
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004866 10043640 Thrombosis venous LLT
    20.0 100000004855 10034191 PE LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-005112-42 Sponsor Protocol Number: C14-62 Start Date*: 2015-06-22
    Sponsor Name:INSERM
    Full Title: A comparative phase2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in Huntington's Disease (TRIHEP 3)
    Medical condition: Huntington's disease
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10070668 Huntington's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-000229-23 Sponsor Protocol Number: DGD 44-044 Start Date*: 2007-08-24
    Sponsor Name:GUERBET
    Full Title: RENAL SAFETY EVALUATION AFTER DOTAREM-ENHANCED MRA COMPARED WITH NON-ENHANCED MRI IN PATIENTS AT HIGH RISK OF DEVELOPING CONTRAST MEDIUM INDUCED NEPHROPATHY.
    Medical condition: Patients suffering from renal insufficiency and scheduled for contrast enhanced-MR angiography or unenhanced-MRI
    Disease: Version SOC Term Classification Code Term Level
    10.0 10038474 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-004404-19 Sponsor Protocol Number: Acadmed18013 Start Date*: 2014-05-07
    Sponsor Name:Hull and East Yorkshire Hospitals NHS Trust
    Full Title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of 28 Day Treatment with Fostair® pMDI 200/12 on biomarkers of platelet adhesion in Patients with Idiopathic pul...
    Medical condition: Idiopathic pulmonary fibrosis
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10021240 Idiopathic pulmonary fibrosis PT
    Population Age: Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-004950-25 Sponsor Protocol Number: D-00272-CT2014001 Start Date*: 2008-01-06
    Sponsor Name:Cell Medica Ltd
    Full Title: WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study
    Medical condition: Acute Myeloid Leukaemia and Chronic Myeloid Leukaemia in adults.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009013 Chronic myeloid leukaemia PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-001377-28 Sponsor Protocol Number: 27577 Start Date*: 2008-06-11
    Sponsor Name:Merck Serono International S.A.
    Full Title: Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of...
    Medical condition: Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosp...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061664 Autoimmune disorder LLT
    9.1 10025139 Lupus erythematosus systemic LLT
    9.1 10047888 Wegener's granulomatosis LLT
    9.1 10002817 Antiphospholipid syndrome LLT
    9.1 10040767 Sjogren's syndrome LLT
    9.1 10039073 Rheumatoid arthritis LLT
    9.1 10028245 Multiple sclerosis LLT
    9.1 10045228 Type I diabetes mellitus LLT
    9.1 10011401 Crohn's disease LLT
    9.1 10009900 Colitis ulcerative LLT
    9.1 10003827 Autoimmune hepatitis LLT
    9.1 10049046 Autoimmune thyroiditis LLT
    9.1 10003822 Autoimmune haemolytic anaemia NOS LLT
    9.1 10034697 Pernicious anemia LLT
    9.1 10028417 Myasthenia gravis LLT
    9.1 10018620 Goodpasture's syndrome LLT
    9.1 10018766 Guillain Barre syndrome LLT
    9.1 10043554 Thrombocytopenia LLT
    9.1 10037153 Psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Prematurely Ended) AT (Prematurely Ended) NL (Prematurely Ended) PT (Prematurely Ended)
    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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