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Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
Sponsor: CSL Behring
Summary
This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)
Official title: An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
171
Start Date
2021-03-29
Completion Date
2025-11-21
Last Updated
2026-06-02
Healthy Volunteers
No
Conditions
Interventions
CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody
Locations (44)
Clinical Research Center of Alabama
Birmingham, Alabama, United States
Research Solutions of Arizona
Litchfield Park, Arizona, United States
Medical Research of Arizona
Scottsdale, Arizona, United States
Little Rock Allergy & Asthma Clinic
Little Rock, Arkansas, United States
Donald S. Levy M.D.
Orange, California, United States
Raffi Tachdjian MD, Inc.
Santa Monica, California, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, United States
Institute for Asthma and Allergy PC
Chevy Chase, Maryland, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
PennState Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
AARA Research Center
Dallas, Texas, United States
Campbelltown Hospital / Western Sydney University
Campbelltown, New South Wales, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital, Department of Clinical Immunology
Murdoch, Western Australia, Australia
University of Alberta - Research Transition Facility
Edmonton, Alberta, Canada
McMaster University
Hamilton, Ontario, Canada
Ottawa Allergy Research Corp
Ottawa, Ontario, Canada
Gordon Sussman Clinical Research
Toronto, Ontario, Canada
Montreal Clinical Research Institute
Montreal, Quebec, Canada
University hospital St. Anna Ustav klinicke imunologie a alergologie, Fakultní nemocnice u sv. Anny v Brně
Brno, Czechia
University Hospital Motol
Prague, Czechia
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Johannes Gutenberg-Universität KöR, Hautklinik und Poliklinik der Universitätsmedizin, Clinical Research Center
Mainz, Germany
HZRM Haemophilie Zentrum Rhein Main GmbH
Mörfelden-Walldorf, Germany
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Semmelweis Egyetem Altalanos Orvostudományi Kar Belgyógyászati és Hematológiai Klinika
Budapest, Hungary
Barzilai University Medical Center
Ashkelon, Israel
Koga Community Hospital
Shizuoka, Daikakuji Yaizu-shi, Japan
Mie University Hospital
Mie, Edobashi, Tsu-shi, Japan
Juntendo University Hospital
Tokyo, Hongo Bunkyo-ku, Japan
Saitama Medical Center
Saitama, Kamoda Kawagoe-shi, Japan
St. Marianna University School of Medicine Hospital
Kanagawa, Kawasaki-shi, Japan
Clover Hospital
Kanagawa, Kugenumaishigami, Fujisawa-shi, Japan
Saiyu Soka Hospital
Saitama, Matsubara Soka-shi, Japan
National Hospital Organization Disaster Medical Center
Tokyo, Midoricho, Tachikawa-shi, Japan
Saga University Hospital
Saga, Nebeshima, Saga-shi, Japan
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
Miyakojima-ku, Osaka-shi, Japan
Amsterdam UMC, location AMC
Amsterdam, Netherlands
Auckland City Hospital
Grafton, Auckland, New Zealand
NRC Institute of Immunology FMBA Russia
Moscow, Russia
Hospital Universitari General de La Vall d'Hebron
Barcelona, Spain
Hospital Gregorio Marañón, Servicio de Alergia
Madrid, Spain
Taichung Veterans General Hospital
Taichung, Taiwan