Hereditary Angioedemas

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

NCT07001280 | OBSERVATIONAL

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 months prior to enrollment in the HAE eDiary. The primary aim of this study is to investigate the real-

9 Sites

200 Participants

RECRUITING

12 Years

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SUBMIT

Medical Research of Arizona

Phoenix,Arizona,United States,85248

John Hopkins University

Baltimore,Maryland,United States,21287

Washington University

St Louis,Missouri,United States,63141

Riverside Medical Group, Belleville

Belleville,New Jersey,United States,07109

HZRM HaemophilieZentrum Rhein Main

Frankfurt am Main,Hesse,Germany,60596

Medizinische Hochschule Hannover

Hanover,Lower Saxony,Germany,30625

Universitaetsklinikum Carl Gustav Carus TU Dresden

Leipzig,Saxony,Germany,01307

Universitaetsklinikum Schleswig Holstein Campus Luebeck

Hamburg,Schleswig-Holstein,Germany,23538

Charit Campus Charit Mitte

Berlin,Schleswig-Holstein,Germany,10117

Study 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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov