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NCT07159464
Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study
Conditions: Hereditary Angioedema (HAE)
Sex: All
Ages: N/A – 11 Years
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07159464). StuddyBuddy aggregates publicly available trial information.