Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study

NCT07159464 | Unknown

• 1 other identifier: CSL312_5001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This protocol for post study access allows pediatric participants (2-11 years old at the time of consent) with HAE who have completed study CSL312\_3003 (NCT05819775) to continue treatment with CSL312 for routine prevention of HAE attacks. The continuing treatment with the study product will be administered under a Post Study Access program in accordance with the applicable laws and regulations, to be dictated by CSL Behring (Sponsor) and approved by the appropriate local/central Ethics Committees and all other competent authorities required by law, as applicable.

Conditions

Hereditary Angioedema (HAE)

Interventions

CSL312 BIOLOGICAL

Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously (SC)

Also known as: Garadacimab

Eligibility Criteria

• Age: Up to 11 Years
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• Completion of treatment period in study CSL312\_3003 (NCT05819775)
• The participant responded to CSL312 treatment with no or very limited number of HAE attacks during the CSL312\_3003 study
• The participant experienced no clinically significant adverse effects associated with CSL312 treatment
• In the opinion of the treating physician, the participant continues to receive benefit from CSL312
• There is no other suitable alternative prophylactic treatment available at the time of consenting into the Post Study Access program

You may not qualify if:

• In the opinion of the treating physician, participant may not be compliant with the Protocol requirements
• Participant is 12 years or older at the time of consent
• In the opinion of the treating physician, other study medication of prophylaxis treatment of HAE may benefit the participant more than continuing treatment with CSL312
• Participant who is pregnant, breastfeeding, or not willing to cease breastfeeding

Sponsors & Collaborators

• CSL Behring: lead

MeSH Terms

Conditions

Angioedemas, Hereditary

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Central Study Contacts

Trial Registration Coordinator

CONTACT

1-610-878-4697; clinicaltrials@cslbehring.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 8, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08