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

Completed · Phase 3

Conditions studied: Hereditary Angioedema (HAE)

In brief

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.

Key facts

Study ID

NCT05819775

Run by

CSL Behring

People needed

22

Starts

2023-05-30

Expected to finish

2025-11-19

Last updated by the study team

2026-06-02

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female
• Aged 2 to 11 years, inclusive, with body weight ≥ 10th percentile based on age
• Diagnosed with clinically confirmed C1-INH HAE
• Experienced ≥ 2 HAE attacks during the 6 months before Screening

You may not qualify if…

• Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria, or HAE type 3
• Use of C1-INH products, androgens, antifibrinolytics, approved or future approved medications, or other small molecule medications for routine prophylaxis against HAE attacks within a minimum of 2 weeks before the Treatment Period
• Participation in another interventional clinical study during the 30 days before the Treatment Period or within 5 half-lives of the final dose of the investigational product administered during the previous interventional study, whichever is longer
• Having laboratory clinical abnormalities assessed as clinically significant by the investigator in results of hematology or chemistry assessments performed during Screening
• Currently receiving a therapy not permitted during the study
• Being pregnant or breastfeeding.

Where it is running

• 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

Full record on ClinicalTrials.gov

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