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

Study Results

Results pending

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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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

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Detailed Description

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Conditions

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Hereditary Angioedema (HAE)

Interventions

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CSL312

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Garadacimab

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No