Actively Recruiting
A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE)
Led by CSL Behring · Updated on 2026-03-27
200
Participants Needed
18
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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-world effectiveness of garadacimab as measured by HAE attack rate before and after garadacimab initiation in patients with HAE over 24 months of follow-up. The study will aim to complement the data available from the clinical development program on the efficacy, safety, and health-related quality-of-life (HRQoL) in patients with HAE taking garadacimab.
CONDITIONS
Official Title
A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged greater than or equal to (>=) 12 years at enrollment.
- Participants with clinical and/or laboratory confirmed diagnosis of HAE.
- 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.
- 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).
- Ability to use an electronic device such as a smartphone or a computer for data collection in the study.
You will not qualify if you...
- Participants with a concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria (histaminergic angioedema).
- 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.
AI-Screening
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Trial Site Locations
Total: 18 locations
1
Medical Research of Arizona
Phoenix, Arizona, United States, 85248
Actively Recruiting
2
Asthma and Allergy Wellness Center
Saint Charles, Illinois, United States, 60175-4827
Actively Recruiting
3
John Hopkins University
Baltimore, Maryland, United States, 21287
Active, Not Recruiting
4
Washington University
St Louis, Missouri, United States, 63141
Active, Not Recruiting
5
Riverside Medical Group, Belleville
Belleville, New Jersey, United States, 07109
Actively Recruiting
6
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
7
HZRM Haemophilie-Zentrum Rhein Main
Frankfurt am Main, Hesse, Germany, 60596
Active, Not Recruiting
8
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
Active, Not Recruiting
9
Universitaetsklinikum Carl Gustav Carus TU Dresden
Leipzig, Saxony, Germany, 01307
Actively Recruiting
10
Universitaetsklinikum Schleswig Holstein - Campus Luebeck
Hamburg, Schleswig-Holstein, Germany, 23538
Actively Recruiting
11
Charité - Campus Charité Mitte
Berlin, Germany, 10117
Actively Recruiting
12
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
13
Barts Health NHS Trust
London, Greater London, United Kingdom, E1 1RD
Actively Recruiting
14
Manchester Royal Infirmary
Manchester, Greater Manchester, United Kingdom, M13 9WL
Actively Recruiting
15
Cardiff & Vale University HB
Cardiff, South Glamorgan, United Kingdom, CF14 4XU
Actively Recruiting
16
Frimley Park Hospital
Frimley, Surrey, United Kingdom, GU16 7UJ
Actively Recruiting
17
Birmingham Heartlands Hospital
Birmingham, West Midlands, United Kingdom, B 9 5SS
Actively Recruiting
18
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Actively Recruiting
Research Team
T
Trial Registration Coordinator
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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