Garadacimab to prevent hereditary angioedema attacks

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multinational, multicenter prospective observational cohort following patients newly initiating garadacimab in routine clinical practice. Each participant will be followed for 48 months after their first dose, with data collected from an electronic HAE eDiary, medical records, and routine clinic visits. The study extracts 12 months of retrospective healthcare resource and safety data from records and 3 months of retrospective attack data from the eDiary. No treatments are assigned by the study; garadacimab use is determined by the treating physician per local labeling.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Medical Research of Arizona
  Phoenix, Arizona, United States Recruiting
• Sirven and Associates
  Miami, Florida, United States Recruiting
• Asthma and Allergy Wellness Center
  Saint Charles, Illinois, United States Recruiting
• Riverside Medical Group, Belleville
  Belleville, New Jersey, United States Recruiting
• Kepler Universitätsklinikum - Med Campus III.
  Linz, Austria Recruiting
• Providence Health Care Society
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Study coordinator: Trial Registration Coordinator
• Email: clinicaltrials@cslbehring.com
• Phone: +1 610-878-4697

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.