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Clinical trials for Icatibant

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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    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).

    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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    23 result(s) found for: Icatibant. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2006-000763-29 Sponsor Protocol Number: PKM6746 Start Date*: 2006-06-12
    Sponsor Name:Sanofi-Aventis Deutschland GmbH
    Full Title: Pharmacokinetics, pharmacodynamics and safety of intra-articular multiple doses of 500 mcg icatibant in an uncontrolled 13-week multi-center study in patients with symptomatic knee osteoarthritis
    Medical condition: Subjects with symptomatic knee osteoarthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed)
    Trial results: View results
    EudraCT Number: 2006-005946-35 Sponsor Protocol Number: EFC10096 Start Date*: 2007-05-17
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: Efficacy and safety of 3 intra-articular injections of 500 µg icatibant in a randomized, double-blind, parallel-group, placebo-controlled 13-week multi-centre study in patients with symptomatic kne...
    Medical condition: patients with painful OA in the knee
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed)
    Trial results: View results
    EudraCT Number: 2005-003258-87 Sponsor Protocol Number: DRI6091 Start Date*: 2006-03-09
    Sponsor Name:Sanofi Aventis Deutschland GmbH
    Full Title: Efficacy and safety of intra-articular multiple doses of 500 µg icatibant including 40 mg triamcinolone as calibrator in a randomized, double-blind, parallel-group, placebo-controlled 13-week multi...
    Medical condition: Subjects with painful osteoarthritis in the knee
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) SI (Completed) LT (Completed) CZ (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2011-003825-81 Sponsor Protocol Number: HGT-FIR-086 Start Date*: 2012-02-28
    Sponsor Name:Shire Orphan Therapies, Inc
    Full Title: A Multicenter, Open-Label, Non-Randomized Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Administration of Icatibant in Children and Adolescents with Heredi...
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    16.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) HU (Prematurely Ended) ES (Prematurely Ended) IT (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-015410-22 Sponsor Protocol Number: AMACE Start Date*: 2010-04-30
    Sponsor Name:Medizinische Fakultaet der Technischen Universitaet Muenchen
    Full Title: A multicenter, randomized, double-blind study with 2 groups as prove of concept for the treatment of ACE induced angioedema with subcutaneous Icatibant
    Medical condition: The study objective is to assess the efficacy and safety of the Bradykinin-2 (BK-2) receptor antagonist Icatibant compared to a historic group of 47 patients with ACE inhibitor induced angioedema w...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-002627-35 Sponsor Protocol Number: TAK-667-3001 Start Date*: 2022-07-25
    Sponsor Name:Takeda Pharmaceutical Company Limited
    Full Title: A Multicenter, Open-Label, Non-randomized Phase 3 Study to Assess the Safety, Efficacy and Pharmacokinetics of Subcutaneous Administration of Icatibant (TAK-667) in Japanese Children and Adolescent...
    Medical condition: Hereditary Angioedema
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-000071-25 Sponsor Protocol Number: JE049-3101 Start Date*: 2009-09-10
    Sponsor Name:Jerini AG
    Full Title: Open-Label, Multicenter Study to Evaluate Safety, Local Tolerability, Convenience, and Efficacy of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of He...
    Medical condition: hereditary angioedema, HAE (in adult patients with C1-esterase-inhibitor deficiency)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10019860 Hereditary angioedema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) GB (Completed) FR (Completed) ES (Completed) IT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-002339-24 Sponsor Protocol Number: NA Start Date*: 2012-05-25
    Sponsor Name:Barts and the London NHS Trust
    Full Title: Open label, single-centre study to evaluate the efficacy of the bradykinin (BK) B2 receptor antagonist, Icatibant, in the relief of symptoms resulting from moderate to severe angioedema unresponsiv...
    Medical condition: Idiopathic Angioedema
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-015606-19 Sponsor Protocol Number: HGT-FIR-054 Start Date*: 2010-01-18
    Sponsor Name:Jerini US Inc
    Full Title: A Phase III Randomized Double-blind, Placebo-controlled Multicenter Study of Icatibant for Subcutaneous Injection in Patients with Acute Attacks of Hereditary Angioedema (HAE)
    Medical condition: Hereditary angioedema (HAE) in adults patients with C1-esterase inhibitor deficiency
    Disease: Version SOC Term Classification Code Term Level
    12.0 10019860 Hereditary angioedema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2004-001540-71 Sponsor Protocol Number: JE049 #2102 Start Date*: 2005-07-23
    Sponsor Name:Jerini AG
    Full Title: Randomised, double blind, controlled, parallel group, multicentre study of a subcutaneous formulation of Icatibant vs. oral Tranexamic acid for the treatment of hereditary angioedema (HAE).
    Medical condition: Hereditary Angioedema (HAE)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) HU (Completed) AT (Completed) LT (Completed) IE (Completed) DE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001213-12 Sponsor Protocol Number: HGT-FIR-096 Start Date*: 2014-09-05
    Sponsor Name:Shire Orphan Therapies, Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study Evaluating the Safety and Efficacy of Icatibant as a Treatment for Angiotensin-Converting Enzyme Inhibitor (ACE...
    Medical condition: ACE-I-induced angioedema
    Disease: Version SOC Term Classification Code Term Level
    17.0 10040785 - Skin and subcutaneous tissue disorders 10002424 Angioedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-002166-13 Sponsor Protocol Number: HUB-MdI-ICAT-COVID-201 Start Date*: 2020-07-09
    Sponsor Name:Dr. Ramón Lleonart Bellfill / Dr. Xavier Corbella Virós
    Full Title: Randomized, open, multicenter phase II clinical trial, proof of concept, to evaluate efficacy and safety of Icatibant in hospitalized patients with SARS-COV-2 (COVID-19) without assisted ventilatio...
    Medical condition: Pneumonia caused by COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    20.0 10022891 - Investigations 10070255 Coronavirus test positive PT
    23.0 10021881 - Infections and infestations 10084381 Coronavirus pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002225-29 Sponsor Protocol Number: AntagoBrad-Cov Start Date*: 2020-11-12
    Sponsor Name:Groupement de Coopération Sanitaire Ramsay Générale de Santé pour l’Enseignement et la Recherche
    Full Title: Evaluation of the effects of bradykinin antagonists on pulmonary manifestations of COVID-19 infections.
    Medical condition: COVID positive patients with respiratory impairment
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004848 10084437 COVID-19 PCR test positive LLT
    23.1 10042613 - Surgical and medical procedures 10084460 COVID-19 treatment PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-019037-10 Sponsor Protocol Number: INITIAtE Start Date*: 2010-11-24
    Sponsor Name:AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
    Full Title: IcatibaNt In Treatment of Idiopathic Angio Edema.
    Medical condition: Idiopathic angioedema.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10051379 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-001703-20 Sponsor Protocol Number: SHP643-303 Start Date*: 2020-08-28
    Sponsor Name:Dyax Corporation, a Takeda company
    Full Title: A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema wi...
    Medical condition: non-histaminergic angioedema with normal C1-INH and acquired angioedema due to C1-INH deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10002425 Angioedemas HLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) HU (Completed) PL (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2022-003168-25 Sponsor Protocol Number: ONCE-AID1.0 Start Date*: 2023-02-28
    Sponsor Name:Academisch Medisch Centrum
    Full Title: Oral ONCE Daily prophylaxis with PHA-022121 in Patients with Acquired C1-Inhibitor Deficiency
    Medical condition: Acquired angioedema due to C1-inhibitor deficiency
    Disease: Version SOC Term Classification Code Term Level
    21.0 10040785 - Skin and subcutaneous tissue disorders 10081035 Acquired C1 inhibitor deficiency PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002478-19 Sponsor Protocol Number: SHP616-300 Start Date*: 2016-06-28
    Sponsor Name:Shire ViroPharma, Inc.
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Two-period, Three-sequence, Partial Crossover Study to Evaluate the Efficacy and Safety of Subcutaneous Administration of 2000 IU of C1 Este...
    Medical condition: hereditary angioedema
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-003966-29 Sponsor Protocol Number: BCX7353-302 Start Date*: Information not available in EudraCT
    Sponsor Name:BioCryst Pharmaceuticals Inc.
    Full Title: A Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two dose levels of BCX7353 as an oral treatment for the prevention of attacks in...
    Medical condition: Hereditary angioedema
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended) IE (Prematurely Ended) GB (GB - no longer in EU/EEA) FR (Completed) DE (Completed) DK (Completed) HU (Completed) CZ (Completed) AT (Completed) NL (Ongoing) BE (Completed) ES (Completed) IT (Prematurely Ended) RO (Completed)
    Trial results: View results
    EudraCT Number: 2021-000720-36 Sponsor Protocol Number: POP-AID1.0 Start Date*: 2021-08-27
    Sponsor Name:Academisch Medisch Centrum
    Full Title: oral PHA-022121 for the acute treatment and prophylaxis Of angioedema attacks in Patients with Acquired C1-Inhibitor Deficiency
    Medical condition: Acquired angioedema due to C1-inhibitor deficiency
    Disease: Version SOC Term Classification Code Term Level
    21.0 10040785 - Skin and subcutaneous tissue disorders 10081035 Acquired C1 inhibitor deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-001272-29 Sponsor Protocol Number: BCX7353-203 Start Date*: 2016-07-26
    Sponsor Name:BioCryst Pharmaceuticals Inc
    Full Title: A randomized, double-blind, placebo-controlled, dose-ranging, parallel-group study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of BCX7353 as a preventative...
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) HU (Completed) ES (Completed) AT (Completed) DK (Completed) GR (Completed)
    Trial results: View results
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