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.
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
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