Hereditary Angioedema (HAE)
Conditions
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.
Interventions
BIOLOGICALCSL312
Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously (SC)
Sponsors
CSL Behring
Eligibility
Sex/Gender
ALL
Age
No minimum to 11 Years
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
Contacts
Primary ContactTrial Registration Coordinator
Outcome results
None listed