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COMPLETED
NCT05819775
PHASE3

CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema

Sponsor: CSL Behring

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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