Status:
AVAILABLE
Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study
Lead Sponsor:
CSL Behring
Conditions:
Hereditary Angioedema (HAE)
Eligibility:
All Genders
Up to 11 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT07159464
Last Update
September 8 2025
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