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Available 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07159464). StuddyBuddy aggregates publicly available trial information.