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Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

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Title: Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.
Authors: Craig TJ; Allergy, Asthma and Immunology, Department of Medicine and Pediatrics, Penn State University, Hershey, PA, USA. Electronic address: tcraig@pennstatehealth.psu.edu., Reshef A; Allergy, Immunology & Angioedema Center, Barzilai University Hospital, Ashkelon, Israel., Li HH; Institute for Asthma and Allergy, Chevy Chase, MD, USA., Jacobs JS; Allergy & Asthma Clinical Research, Walnut Creek, CA, USA., Bernstein JA; University of Cincinnati, Department of Internal Medicine Division of Rheumatology, Allergy and Immunology and the Bernstein Clinical Research Center Cincinnati, Cincinnati, OH, USA., Farkas H; Department of Internal Medicine and Haematology, Hungarian Angioedema Center of Reference and Excellence, Semmelweis University, Budapest, Hungary., Yang WH; Ottawa Allergy Research Corporation, Department of Medicine, University of Ottawa, Ottawa, ON, Canada., Stroes ESG; Department of Vascular Medicine, Amsterdam UMC, Amsterdam, Netherlands., Ohsawa I; Department of Nephrology, Saiyu Soka Hospital, Saitama, Japan., Tachdjian R; Division of Allergy & Clinical Immunology, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA., Manning ME; Allergy, Asthma & Immunology Associates, Ltd, Internal Medicine, UA College of Medicine, Phoenix, Phoenix, AZ, USA., Lumry WR; AARA Research Center, Dallas, TX, USA., Saguer IM; HZRM Haemophilia Center Rhein Main, Mörfelden-Walldorf, Germany., Aygören-Pürsün E; Klinikum der Johann Wolfgang-Goethe Universität, Klinik für Kinder- und Jugendmedizin, Frankfurt, Germany., Ritchie B; Division of Hematology, Department of Medicine, University of Alberta, Edmonton, AB, Canada., Sussman GL; Gordon Sussman Clinical Research Inc and Department of Clinical Immunology and Allergy, St Michael's Hospital, Toronto, ON, Canada., Anderson J; AllerVie Clinical Research, Birmingham, AL, USA., Kawahata K; St Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan., Suzuki Y; Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo, Japan., Staubach P; Department of Dermatology and Allergy, University Medical Center, Mainz, Germany., Treudler R; University Leipzig Medical Faculty, Department of Dermatology, Venereology and Allergology, Leipzig Interdisciplinary Center for Allergology-CAC, Leipzig, Germany., Feuersenger H; CSL Behring Innovation GmbH, Marburg, Germany., Glassman F; CSL Behring, King of Prussia, PA, USA., Jacobs I; CSL Behring, King of Prussia, PA, USA., Magerl M; Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Frauhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany.
Source: Lancet (London, England) [Lancet] 2023 Apr 01; Vol. 401 (10382), pp. 1079-1090. Date of Electronic Publication: 2023 Feb 28.
Publication Type: Randomized Controlled Trial; Multicenter Study; Clinical Trial, Phase III; Journal Article
Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 2985213R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-547X (Electronic) Linking ISSN: 01406736 NLM ISO Abbreviation: Lancet Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.
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  Data: <searchLink fieldCode="AU" term="%22Craig+TJ%22">Craig TJ</searchLink>; Allergy, Asthma and Immunology, Department of Medicine and Pediatrics, Penn State University, Hershey, PA, USA. Electronic address: tcraig@pennstatehealth.psu.edu.<br /><searchLink fieldCode="AU" term="%22Reshef+A%22">Reshef A</searchLink>; Allergy, Immunology & Angioedema Center, Barzilai University Hospital, Ashkelon, Israel.<br /><searchLink fieldCode="AU" term="%22Li+HH%22">Li HH</searchLink>; Institute for Asthma and Allergy, Chevy Chase, MD, USA.<br /><searchLink fieldCode="AU" term="%22Jacobs+JS%22">Jacobs JS</searchLink>; Allergy & Asthma Clinical Research, Walnut Creek, CA, USA.<br /><searchLink fieldCode="AU" term="%22Bernstein+JA%22">Bernstein JA</searchLink>; University of Cincinnati, Department of Internal Medicine Division of Rheumatology, Allergy and Immunology and the Bernstein Clinical Research Center Cincinnati, Cincinnati, OH, USA.<br /><searchLink fieldCode="AU" term="%22Farkas+H%22">Farkas H</searchLink>; Department of Internal Medicine and Haematology, Hungarian Angioedema Center of Reference and Excellence, Semmelweis University, Budapest, Hungary.<br /><searchLink fieldCode="AU" term="%22Yang+WH%22">Yang WH</searchLink>; Ottawa Allergy Research Corporation, Department of Medicine, University of Ottawa, Ottawa, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Stroes+ESG%22">Stroes ESG</searchLink>; Department of Vascular Medicine, Amsterdam UMC, Amsterdam, Netherlands.<br /><searchLink fieldCode="AU" term="%22Ohsawa+I%22">Ohsawa I</searchLink>; Department of Nephrology, Saiyu Soka Hospital, Saitama, Japan.<br /><searchLink fieldCode="AU" term="%22Tachdjian+R%22">Tachdjian R</searchLink>; Division of Allergy & Clinical Immunology, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA.<br /><searchLink fieldCode="AU" term="%22Manning+ME%22">Manning ME</searchLink>; Allergy, Asthma & Immunology Associates, Ltd, Internal Medicine, UA College of Medicine, Phoenix, Phoenix, AZ, USA.<br /><searchLink fieldCode="AU" term="%22Lumry+WR%22">Lumry WR</searchLink>; AARA Research Center, Dallas, TX, USA.<br /><searchLink fieldCode="AU" term="%22Saguer+IM%22">Saguer IM</searchLink>; HZRM Haemophilia Center Rhein Main, Mörfelden-Walldorf, Germany.<br /><searchLink fieldCode="AU" term="%22Aygören-Pürsün+E%22">Aygören-Pürsün E</searchLink>; Klinikum der Johann Wolfgang-Goethe Universität, Klinik für Kinder- und Jugendmedizin, Frankfurt, Germany.<br /><searchLink fieldCode="AU" term="%22Ritchie+B%22">Ritchie B</searchLink>; Division of Hematology, Department of Medicine, University of Alberta, Edmonton, AB, Canada.<br /><searchLink fieldCode="AU" term="%22Sussman+GL%22">Sussman GL</searchLink>; Gordon Sussman Clinical Research Inc and Department of Clinical Immunology and Allergy, St Michael's Hospital, Toronto, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Anderson+J%22">Anderson J</searchLink>; AllerVie Clinical Research, Birmingham, AL, USA.<br /><searchLink fieldCode="AU" term="%22Kawahata+K%22">Kawahata K</searchLink>; St Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan.<br /><searchLink fieldCode="AU" term="%22Suzuki+Y%22">Suzuki Y</searchLink>; Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Staubach+P%22">Staubach P</searchLink>; Department of Dermatology and Allergy, University Medical Center, Mainz, Germany.<br /><searchLink fieldCode="AU" term="%22Treudler+R%22">Treudler R</searchLink>; University Leipzig Medical Faculty, Department of Dermatology, Venereology and Allergology, Leipzig Interdisciplinary Center for Allergology-CAC, Leipzig, Germany.<br /><searchLink fieldCode="AU" term="%22Feuersenger+H%22">Feuersenger H</searchLink>; CSL Behring Innovation GmbH, Marburg, Germany.<br /><searchLink fieldCode="AU" term="%22Glassman+F%22">Glassman F</searchLink>; CSL Behring, King of Prussia, PA, USA.<br /><searchLink fieldCode="AU" term="%22Jacobs+I%22">Jacobs I</searchLink>; CSL Behring, King of Prussia, PA, USA.<br /><searchLink fieldCode="AU" term="%22Magerl+M%22">Magerl M</searchLink>; Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Frauhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany.
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  Data: <searchLink fieldCode="JN" term="%222985213R%22">Lancet (London, England)</searchLink> [Lancet] 2023 Apr 01; Vol. 401 (10382), pp. 1079-1090. <i>Date of Electronic Publication: </i>2023 Feb 28.
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  Data: Randomized Controlled Trial; Multicenter Study; Clinical Trial, Phase III; Journal Article
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%22">Elsevier </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>2985213R <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1474-547X (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2201406736%22">01406736 </searchLink><i>NLM ISO Abbreviation: </i>Lancet <i>Subsets: </i>MEDLINE
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