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CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT05819775•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.

Eligibility

Age

2 - 11 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Male or female
•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

•1\. Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria, or HAE type 3
•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.

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

Key Dates

Start Date

May 30, 2023

Primary Completion Date

November 19, 2025

Completion Date

November 19, 2025

Last Updated

January 26, 2026

Enrollment

ACTUAL participants

Conditions

Hereditary Angioedema (HAE)

Interventions

CSL312

BIOLOGICAL

Donidalorsen Treatment in Children With Hereditary Angioedema

NCT07298447

Hereditary Angioedema (HAE)

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RECRUITINGPHASE3

A Study of Navenibart in Participants With Hereditary Angioedema

NCT06842823

Hereditary Angioedema (HAE)

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ACTIVE_NOT_RECRUITING

A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

NCT05469789

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Donidalorsen Treatment in Children With Hereditary Angioedema

A Study of Navenibart in Participants With Hereditary Angioedema

A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)

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