MedTrace Logo

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

NCT07159464 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-09-08

No results posted yet for this study

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

BIOLOGICAL

CSL312

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

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Eligibility

Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07159464 on ClinicalTrials.gov