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CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema
Sponsor: CSL Behring
Summary
The purpose of this study is to investigate the safety, PK / PD, and efficacy of SC CSL312 for prophylactic treatment of pediatric subjects with HAE.
Official title: A Phase 3 Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema in Pediatric Subjects 2 to 11 Years of Age
Key Details
Gender
All
Age Range
2 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2023-05-30
Completion Date
2025-11-19
Last Updated
2026-06-02
Healthy Volunteers
No
Conditions
Interventions
CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously (SC)
Locations (13)
Research Solutions of Arizona
Litchfield Park, Arizona, United States
Medical Research of Arizona
Scottsdale, Arizona, United States
Donald S. Levy M.D.
Orange, California, United States
Raffi Tachdjian MD, Inc.
Santa Monica, California, United States
Bernstein Clinical Research
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, Australia
Ottawa Allergy Research Corp
Ottawa, Canada
HZRM Hämophilie Zentrum Rhein Main GmbH
Frankfurt am Main, Hesse, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Barzilai University Medical Center
Ashkelon, Israel