NCT07159464AvailableNot Applicable
Post Study Access of CSL312 (Garadacimab) for the Routine Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Participants (2-11 Years Old) With HAE Who Have Completed the CSL312_3003 Study
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Available
- Sponsor
- CSL Behring
Study Overview
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.
Study Design
- Study Type
- Expanded Access
Eligibility Criteria
- Ages
- — to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
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