Trials / Available
AvailableNCT07159464
Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study
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
- Status
- Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 11 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CSL312 | Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously (SC) |
Timeline
- First posted
- 2025-09-08
- Last updated
- 2025-09-08
Source: ClinicalTrials.gov record NCT07159464. Inclusion in this directory is not an endorsement.