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New injection shows promise for long-term prevention of rare swelling disorder

NCT ID NCT04739059

Completed Disease control Sponsor: CSL Behring Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the long-term safety and effectiveness of garadacimab, a monthly injection, for preventing attacks of hereditary angioedema (HAE) — a rare condition causing severe swelling. 171 people aged 12 and older who had frequent HAE attacks took part. The goal was to see if the drug could safely reduce attack rates over time.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
garadacimab (a monoclonal antibody injection)
What this could lead to
If successful, this could provide a long-term preventive option to reduce swelling attacks in people with hereditary angioedema.
What could go wrong
This is an open-label study without a placebo group, so results may be less reliable. Side effects or lack of lasting benefit are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

hereditary angioedema hereditary angioedema with C1Inh deficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEREDITARY ANGIOEDEMA

Contacts and locations

Locations

  • AARA Research Center

    Dallas, Texas, 75231, United States

  • Allergy & Asthma Clinical Research

    Walnut Creek, California, 94598, United States

  • Amsterdam UMC, location AMC

    Amsterdam, 1105, Netherlands

  • Auckland City Hospital

    Grafton, Auckland, 1023, New Zealand

  • Barzilai University Medical Center

    Ashkelon, 7830604, Israel

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio, 45236, United States

  • Campbelltown Hospital / Western Sydney University

    Campbelltown, New South Wales, 2560, Australia

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35209, United States

  • Clover Hospital

    Kanagawa, Kugenumaishigami, Fujisawa-shi, 251-0025, Japan

  • Donald S. Levy M.D.

    Orange, California, 92868, United States

  • Fiona Stanley Hospital, Department of Clinical Immunology

    Murdoch, Western Australia, 6150, Australia

  • Gordon Sussman Clinical Research

    Toronto, Ontario, M3B 3S6, Canada

  • HZRM Haemophilie Zentrum Rhein Main GmbH

    Mörfelden-Walldorf, 64546, Germany

  • Hospital Gregorio Marañón, Servicio de Alergia

    Madrid, 28007, Spain

  • Hospital Universitari General de La Vall d'Hebron

    Barcelona, 8035, Spain

  • Institute for Asthma and Allergy PC

    Chevy Chase, Maryland, 20815, United States

  • Johannes Gutenberg-Universität KöR, Hautklinik und Poliklinik der Universitätsmedizin, Clinical Research Center

    Mainz, 55131, Germany

  • Juntendo University Hospital

    Tokyo, Hongo Bunkyo-ku, 113-8431, Japan

  • Koga Community Hospital

    Shizuoka, Daikakuji Yaizu-shi, 425-0088, Japan

  • Little Rock Allergy & Asthma Clinic

    Little Rock, Arkansas, 72205, United States

  • Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital

    Miyakojima-ku, Osaka-shi, 534-0021, Japan

  • McMaster University

    Hamilton, Ontario, L8N 3Z5, Canada

  • Medical Research of Arizona

    Scottsdale, Arizona, 85251, United States

  • Mie University Hospital

    Mie, Edobashi, Tsu-shi, Edobashi, Tsu-shi, Japan

  • Montreal Clinical Research Institute

    Montreal, Quebec, H2W 1R7, Canada

  • NRC Institute of Immunology FMBA Russia

    Moscow, 115522, Russia

  • National Hospital Organization Disaster Medical Center

    Tokyo, Midoricho, Tachikawa-shi, 190-0014, Japan

  • Ottawa Allergy Research Corp

    Ottawa, Ontario, K1H 1E4, Canada

  • PennState Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Raffi Tachdjian MD, Inc.

    Santa Monica, California, 90404, United States

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340, United States

  • Saga University Hospital

    Saga, Nebeshima, Saga-shi, 849-8501, Japan

  • Saitama Medical Center

    Saitama, Kamoda Kawagoe-shi, 350-8550, Japan

  • Saiyu Soka Hospital

    Saitama, Matsubara Soka-shi, 340-0041, Japan

  • Semmelweis Egyetem Altalanos Orvostudományi Kar Belgyógyászati és Hematológiai Klinika

    Budapest, 1088, Hungary

  • St. Marianna University School of Medicine Hospital

    Kanagawa, Kawasaki-shi, 216-8511, Japan

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The University of Hong Kong, Queen Mary Hospital

    Hong Kong, Hong Kong

  • University Hospital Motol

    Prague, 150 06, Czechia

  • University hospital St. Anna Ustav klinicke imunologie a alergologie, Fakultní nemocnice u sv. Anny v Brně

    Brno, 65691, Czechia

  • University of Alberta - Research Transition Facility

    Edmonton, Alberta, T6G 2B7, Canada

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590, Germany

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