CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema
NCT ID: NCT05819775
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
22 participants
INTERVENTIONAL
2023-05-30
2025-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CSL312
Ages 2-5 years and 6-11 years will have specific subcutaneous dosing schedules
CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously (SC)
Interventions
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CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously (SC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2\. Aged 2 to 11 years, inclusive, with body weight ? 10th percentile based on age
* 3\. Diagnosed with clinically confirmed C1-INH HAE
* 4\. Experienced ? 2 HAE attacks during the 6 months before Screening
Exclusion Criteria
* 2\. 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
* 3\. 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
* 4\. Having laboratory clinical abnormalities assessed as clinically significant by the investigator in results of hematology or chemistry assessments performed during Screening
* 5\. Currently receiving a therapy not permitted during the study
* 6\. Being pregnant or breastfeeding.
2 Years
11 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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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
Countries
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Other Identifiers
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2022-502386-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
CSL312_3003
Identifier Type: -
Identifier Source: org_study_id
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