A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE)

Launched by CSL BEHRING · May 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called garadacimab for treating patients with Hereditary Angioedema (HAE), a condition that causes sudden swelling in various parts of the body. The study will follow patients who are starting garadacimab for the first time, observing them for up to four years to see how well the medication reduces the number of HAE attacks they experience. Researchers will gather information through a digital diary where patients can record their experiences, as well as from their medical records.

To participate in this study, individuals must be at least 12 years old and have a confirmed diagnosis of HAE. They should be starting treatment with garadacimab as directed by their doctor. Participants will need to be able to use a smartphone or computer for data collection. Throughout the study, patients can expect to regularly provide updates on their health and any HAE attacks they may have. Importantly, this study is not yet recruiting participants, but it aims to provide valuable insights into how garadacimab works in real-world settings, complementing previous clinical research.

Gender

ALL

Eligibility criteria

• 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.