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Clinical trials for Reversal potential

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   44336   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).

    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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    45 result(s) found for: Reversal potential. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2013-004813-41 Sponsor Protocol Number: 1321.3 Start Date*: 2014-05-26
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A Phase III case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075) in patients treated wtih dabigatran ...
    Medical condition: Hemorrhage
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004866 10019524 Hemorrhage LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IE (Completed) PT (Completed) SE (Completed) ES (Completed) FI (Completed) EE (Completed) LV (Prematurely Ended) CZ (Completed) IT (Completed) SK (Completed) NL (Completed) BE (Completed) AT (Completed) NO (Completed) DK (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-005410-19 Sponsor Protocol Number: HH-AT-001 Start Date*: 2013-03-11
    Sponsor Name:Jessaziekenhuis Hasselt
    Full Title: Developing a Patient Model of Controlled, Radial Artery Access Site Bleeding for Deciding on Anticoagulation Reversal in Patients Treated by Systemic Anticoagulants.
    Medical condition: With the novel oral anticoagulants, including EDOXABAN-DABIGATRANRIVAROXABAN- APIXABAN, we are entering a new era of anticoagulation for atrial fibrillation (AF) (and deep vein thrombosis). Neve...
    Disease: Version SOC Term Classification Code Term Level
    15.1 10022891 - Investigations 10060319 Anticoagulation drug level therapeutic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-001201-27 Sponsor Protocol Number: P07038 Start Date*: 2011-11-07
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA
    Full Title: A randomized, controlled, parallel-group, double-blind trial of sugammadex or usual care (neostigmine or spontaneous recovery) for reversal of rocuronium- or vecuronium-induced neuromuscular blocka...
    Medical condition: not applicable
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) NL (Prematurely Ended) AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-002177-37 Sponsor Protocol Number: 1321.7 Start Date*: 2016-06-01
    Sponsor Name:Boehringer Ingelheim AB
    Full Title: Single dose, open label, uncontrolled, safety trial of intravenous administration of idarucizumab to paediatric patients enrolled from ongoing phase IIb/III clinical trials with dabigatran etexilat...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004866 10066899 Venous thromboembolism LLT
    18.1 100000004865 10049909 Venous thromboembolism prophylaxis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) LT (Completed) CZ (Completed) IT (Completed) DE (Completed) Outside EU/EEA GR (Completed) HU (Completed) BE (Completed) ES (Prematurely Ended) BG (Completed) AT (Completed) FI (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-000692-92 Sponsor Protocol Number: MK-8616-089 Start Date*: 2019-02-01
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 4 Double-Blinded, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade ...
    Medical condition: Reversal of neuromuscular blockade (NMB)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10018061 General anesthesia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) ES (Completed) FI (Completed) BE (Completed) DK (Completed)
    Trial results: View results
    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: 2020-000374-21 Sponsor Protocol Number: 19-515 Start Date*: 2020-08-17
    Sponsor Name:Alexion Pharmaceuticals, Inc
    Full Title: PROSPECTIVE, OPEN-LABEL STUDY OF ANDEXANET ALFA IN PATIENTS RECEIVING A FACTOR XA INHIBITOR WHO REQUIRE URGENT SURGERY (ANNEXA-S)
    Medical condition: Need for FXa inhibitor reversal in patients undergoing urgent surgery.
    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 (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000608-16 Sponsor Protocol Number: 5466 Start Date*: 2011-12-21
    Sponsor Name:The Newcastle upon Tyne Hospitals NHS Foundation Trust [...]
    1. The Newcastle upon Tyne Hospitals NHS Foundation Trust
    2. The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Full Title: To evaluate the safety and effectiveness of human ex vivo expanded autologous limbal stem cells for the treatment of unilateral total limbal stem cell deficiency
    Medical condition: unilateral total limbal stem cell deficiency
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-007162-38 Sponsor Protocol Number: 19.4.335 Start Date*: 2008-03-17
    Sponsor Name:NV Organon
    Full Title: A multi-center, open label trial, to show efficacy and safety of 4.0 mg.kg-1 sugammadex administered at a depth of neuromuscular blockade of 1-2 PTC induced by rocuronium in Chinese and European AS...
    Medical condition: Not applicable
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2017-000187-15 Sponsor Protocol Number: MK-8616-145 Start Date*: 2017-09-18
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 4 Randomized, Active-Comparator Controlled Clinical Trial to Study the Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecu...
    Medical condition: Reversal of neuromuscular blockade
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10018061 General anesthesia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2007-006304-37 Sponsor Protocol Number: 19.4.324 Start Date*: 2008-03-19
    Sponsor Name:NV Organon
    Full Title: A multi-center, randomized, parallel-group, active-controlled, safety-assessor blinded trial, comparing the efficacy and safety of 2.0 mg.kg-1 sugammadex with 50 μg.kg-1 neostigmine administered at...
    Medical condition: Not applicable
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2005-003001-85 Sponsor Protocol Number: BDD Start Date*: 2005-11-28
    Sponsor Name:Austrian Forum against Cancer
    Full Title: Bortezomib-Doxorubicin-Dexamethasone (BDD) as Treatment for Patients with Multiple Myeloma Presenting with Acute Renal Failure
    Medical condition: The occurrence of renal failure is an emergency situation in patients with multiple myeloma. A fast active relatively, non-toxic protocol seems presently the best option for attempts to reverse ren...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) CZ (Completed) HU (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2019-002232-82 Sponsor Protocol Number: KIH18001 Start Date*: 2019-07-25
    Sponsor Name:Karolinska Institutet
    Full Title: Downstream targets of SSRI effect in treatment of Major Depressive Disorder
    Medical condition: Major depressive disorder (MDD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001926-25 Sponsor Protocol Number: B300201316844 Start Date*: 2013-09-23
    Sponsor Name:Universitair Ziekenhuis Antwerpen
    Full Title: Sugammadex and the diaphragm: recovery of diaphragmatic function and neuromuscular blockade
    Medical condition: Residual neuromuscular blockade and diphragm fatigue
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000295-38 Sponsor Protocol Number: IMPEDE Start Date*: 2020-05-27
    Sponsor Name:AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
    Full Title: Phase II trial, open label, single-arm, of Immune Checkpoint Inhibitor In High Risk Oral Premalignant Lesions
    Medical condition: Clinical and histological evidence of Oral Premalignant Lesions (OPL) with high risk of malignant transformation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10022891 - Investigations 10078906 Oral soft tissue biopsy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001785-26 Sponsor Protocol Number: 14-505 Start Date*: 2016-02-15
    Sponsor Name:Portola Pharmaceuticals, Inc.
    Full Title: Prospective, Open-label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor who Have Acute Major Bleeding (ANNEXA-4).
    Medical condition: Uncontrolled bleeding in patients who have taken either a direct factor Xa inhibitor (novel oral anticoagulants) or an indirect factor Xa inhibitor (low molecular weight heparins).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000022097 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (Completed) BE (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-002721-18 Sponsor Protocol Number: AC-054-203 Start Date*: 2016-02-17
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A prospective, multi-center, open-label, single-arm, Phase 2 study to assess the efficacy and safety of clazosentan in reversing angiographically-confirmed cerebral vasospasm in adult subjects with...
    Medical condition: Aneurysmal subarachnoid hemorrhage (aSAH); cerebral vasospasm
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004852 10047164 Vasospasm cerebral LLT
    19.1 100000004863 10042320 Subarachnoid hemorrhage LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000188-33 Sponsor Protocol Number: MK-8616-146 Start Date*: 2017-10-27
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 4 Randomized, Active-Comparator Controlled Trial to Study the Efficacy and Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or ...
    Medical condition: Reversal of neuromuscular blockade
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10018061 General anesthesia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) BE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-001668-21 Sponsor Protocol Number: FDE_2014_25 Start Date*: Information not available in EudraCT
    Sponsor Name:Fondation Ophtalomologique A. de Rothschild
    Full Title: Addition of neuromuscular-blocking agents during induction in infants: potential interest in reducing hypoxia episodes
    Medical condition: Chirurgie programmée sous anesthésie générale avec intubation orotrachéale, avec induction inhalatoire prévue
    Disease: Version SOC Term Classification Code Term Level
    21.0 10042613 - Surgical and medical procedures 10002326 Anesthetic induction LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004829-82 Sponsor Protocol Number: GHREDECIDE Start Date*: 2019-04-16
    Sponsor Name:Linköping University
    Full Title: Effects of the appetite-inducing hormone ghrelin on decision making in healthy volunteers
    Medical condition: NA, healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    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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