Status:
RECRUITING
A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE)
Lead Sponsor:
CSL Behring
Conditions:
Hereditary Angioedemas
Eligibility:
All Genders
12+ years
Brief Summary
This is a multinational, multicenter, prospective, observational cohort study of patients with HAE in the real-world setting. The study will include patients newly initiating garadacimab in routine cl...
Eligibility Criteria
Inclusion
- 1\. Participants aged greater than or equal to (\>=) 12 years at enrollment.
- 2\. Participants with clinical and/or laboratory confirmed diagnosis of HAE.
- 3\. Participants newly initiating garadacimab, as prescribed according to the decision of the treating physician per routine clinical practice and in accordance with the indication per the approved local label, independent of and prior to enrollment in the study.
- 4\. Willing and able to provide written informed consent and/or assent by parent or legal guardian for children less than (\<) 18 years of age (or legal age of consent in the respective countries).
- 5\. Ability to use an electronic device such as a smartphone or a computer for data collection in the study.
Exclusion
- 1\. Participants with a concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria (histaminergic angioedema).
- 2\. Participants participating in any ongoing interventional clinical study, including interventional studies with garadacimab. Participants in this study who later chose to enroll in any interventional clinical study (including garadacimab) will be discontinued from this study.
Key Trial Info
Start Date :
July 21 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07001280
Start Date
July 21 2025
End Date
August 31 2030
Last Update
December 12 2025
Active Locations (9)
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1
Medical Research of Arizona
Phoenix, Arizona, United States, 85248
2
John Hopkins University
Baltimore, Maryland, United States, 21287
3
Washington University
St Louis, Missouri, United States, 63141
4
Riverside Medical Group, Belleville
Belleville, New Jersey, United States, 07109