CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
Completed · Phase 3 · Has a placebo group
Conditions studied: Hereditary Angioedema
In brief
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.
Key facts
- Study ID
- NCT04656418
- Run by
- CSL Behring
- People needed
- 64
- Starts
- 2021-01-27
- Expected to finish
- 2022-06-07
- Last updated by the study team
- 2023-06-29
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female ≥ 12 years of age; diagnosed with clinically confirmed C1-INH hereditary angioedema; experience ≥ 3 attacks during the 3 months before screening.
- Note: For subjects taking any prophylactic HAE therapy during the 3 months before Screening, ≥ 3 HAE attacks may be documented over 3 consecutive months before commencing the prophylactic therapy.
You may not qualify if…
- Concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticarial or hereditary angioedema type 3
Where it is running
- Clinical Research Center of Alabama — Birmingham, Alabama, United States
- Medical Research of Arizona — Scottsdale, Arizona, United States
- Raffi Tachdjian MD, Inc. — Santa Monica, California, United States
- Allergy and Asthma Clinical Research — Walnut Creek, California, United States
- Institute of Asthma and Allergy — Chevy Chase, Maryland, United States
- Bernstein Clinical Research Center LLC — Cincinnati, Ohio, United States
- Pennsylvania State University — Hershey, Pennsylvania, United States
- AARA Research Center — Dallas, Texas, United States
- University of Alberta - Research Transition Facility — Edmonton, Alberta, Canada
- Ottawa Allergy Research Corp — Ottawa, Ontario, Canada
- Gordon Sussman Clinical Research Inc. — Toronto, Ontario, Canada
- Clinique specialisee en allergie de la Capitale — Québec, Canada
- Universitätsklinikum Frankfurt Goethe-Universität — Frankfurt am Main, Hesse, Germany
- Charité Universitätsmedizin Berlin — Berlin, Germany
- Universitätsklinikum Leipzig — Leipzig, Germany
- CRC Clinical Research / Hautklinik und Poliklinik der Universitätsklinik Mainz — Mainz, Germany
- HZRM Hämophilie Zentrum Rhein Main GmbH — Mörfelden-Walldorf, Germany
- Semmelweis University — Budapest, Hungary
- Barzilai University Medical Center — Ashkelon, Israel
- Hiroshima University Hospital — Hiroshima, Hiroshima, Japan
- Kobe University Hospital — Kobe, Hyōgo, Japan
- St.Marianna University School of Medicine Hospital — Kawasaki-shi, Kanagawa, Japan
- Saitama Medical Center — Saitama, Kawagoe-shi, Japan
- Saga University Hospital — Saga, Saga-shi, Japan
- Koga Community Hospital — Yaizu-shi, Shizuoka, Japan
Full record on ClinicalTrials.gov
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