CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
NCT ID: NCT04656418
Last Updated: 2023-06-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
64 participants
INTERVENTIONAL
2021-01-27
2022-06-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
NCT04739059
Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab
NCT06806657
Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study
NCT07159464
CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema
NCT05819775
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
NCT03712228
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CSL312
Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg subcutaneous (SC) injections, once monthly from Months 2 to 6.
CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
Placebo
Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.
Placebo
Buffer without active ingredient
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
Placebo
Buffer without active ingredient
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CSL Behring
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
CSL Behring LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Juntendo University Hospital
Bunkyo, Tokyo, Japan
Saiyu Soka Hospital
Saitama, , Japan
Amsterdam UMC, Location AMC
Amsterdam, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Craig TJ, Reshef A, Li HH, Jacobs JS, Bernstein JA, Farkas H, Yang WH, Stroes ESG, Ohsawa I, Tachdjian R, Manning ME, Lumry WR, Saguer IM, Aygoren-Pursun E, Ritchie B, Sussman GL, Anderson J, Kawahata K, Suzuki Y, Staubach P, Treudler R, Feuersenger H, Glassman F, Jacobs I, Magerl M. 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. Lancet. 2023 Apr 1;401(10382):1079-1090. doi: 10.1016/S0140-6736(23)00350-1. Epub 2023 Feb 28.
Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-000570-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSL312_3001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.