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

Recruitingn/aAges 12 Years - anyAllCSL Behring
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In plain words

What the trial is, and whether it could suit you

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 clinical practice. Each participant will be followed for 48 months after index date (date of the first administration of garadacimab). Patient data will be collected from the HAE eDiary, patient medical records (MRs) and/or during a routine clinical visit and will be entered into the electronic case report form (eCRF) via an electronic data capture (EDC) system. Data pertaining to HAE attacks, prior HAE treatments, retrospective focused safety data collection, and healthcare resource utilization (HCRU) over a look-back period of 12 months prior to the enrollment will be extracted from the MR, and patients will also record retrospective HAE attack related data over a look-back period of 3 mont

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • No intervention
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Where

22 sites
Medical Research of Arizona
Phoenix, United States
Sirven and Associates
Miami, United States
Asthma and Allergy Wellness Center
Saint Charles, United States
Family Allergy and Asthma
Louisville, United States
John Hopkins University
Baltimore, United States
Washington University
St Louis, United States
Riverside Medical Group, Belleville
Belleville, United States
Kepler Universitätsklinikum - Med Campus III.
Linz, Austria

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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