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Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study
Sponsor: CSL Behring
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.
Official title: Post Study Access of CSL312 (Garadacimab) for the Routine Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Participants (2-11 Years Old) With HAE Who Have Completed the CSL312_3003 Study
Key Details
Gender
All
Age Range
Any - 11 Years
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-10-09
Healthy Volunteers
Not specified
Conditions
Interventions
CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously (SC)