Actively Recruiting
Garadacimab Real-world Treatment Outcomes of Effectiveness, Safety, and Quality-of-Life in Patients With Hereditary Angioedema (GREAT Study)
Led by CSL Behring · Updated on 2026-06-03
200
Participants Needed
22
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multinational, multicenter observational study to understand the real-world use of garadacimab in patients with hereditary angioedema (HAE). The study includes patients who are newly starting garadacimab treatment as part of their regular clinical care. The main goal is to evaluate the effectiveness of garadacimab by comparing the rate of HAE attacks before and after treatment over a 24-month period, along with assessing safety and quality of life. Participants will receive garadacimab as prescribed by their doctors in routine practice, without any additional interventions from the study. There is one study group consisting of patients treated with garadacimab. Data collection includes information from patient medical records, electronic diaries, and routine clinical visits. Retrospective and prospective data on HAE attacks, prior treatments, safety, and healthcare resource use will be gathered throughout the study. Each participant will be followed for 48 months from the first garadacimab dose. During this time, researchers will collect data through electronic diaries, medical record reviews, and scheduled clinical assessments. Outcome measures include attack rates, adverse event monitoring, angioedema control, and quality-of-life questionnaires. This long-term follow-up helps capture the real-world experience and safety of garadacimab in routine care.
CONDITIONS
Brief 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 12 years or older at enrollment
- Clinical and/or laboratory confirmed diagnosis of hereditary angioedema (HAE)
- Newly starting garadacimab treatment as prescribed by their physician in routine practice
- Willing and able to provide written informed consent or assent by a parent/legal guardian for children under 18
- Ability to use an electronic device such as a smartphone or computer for study data collection
You will not qualify if you...
- Diagnosis of another form of angioedema such as idiopathic, acquired, or histaminergic angioedema
- Currently participating in any other interventional clinical study, including those involving garadacimab
- Participants who enroll in another interventional study after joining this study will be discontinued from this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 months
Participants who start garadacimab treatment as part of their routine clinical care are observed to assess effectiveness, safety, and quality of life over time.
Regular visits as part of routine care; additional study assessments conducted periodically
Trial Site Locations
Total: 22 locations
1
Medical Research of Arizona
Phoenix, Arizona, United States, 85248
Actively Recruiting
2
Sirven and Associates
Miami, Florida, United States, 33183
Actively Recruiting
3
Asthma and Allergy Wellness Center
Saint Charles, Illinois, United States, 60175-4827
Actively Recruiting
4
Family Allergy and Asthma
Louisville, Kentucky, United States, 40217
Not Yet Recruiting
5
John Hopkins University
Baltimore, Maryland, United States, 21287
Active, Not Recruiting
6
Washington University
St Louis, Missouri, United States, 63141
Active, Not Recruiting
7
Riverside Medical Group, Belleville
Belleville, New Jersey, United States, 07109
Actively Recruiting
8
Kepler Universitätsklinikum - Med Campus III.
Linz, Austria, 4021
Actively Recruiting
9
Providence Health Care Society
Vancouver, British Columbia, Canada, V6Z 2K5
Actively Recruiting
10
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
11
HZRM Haemophilie-Zentrum Rhein Main
Frankfurt am Main, Hesse, Germany, 60596
Active, Not Recruiting
12
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
Active, Not Recruiting
13
Universitaetsklinikum Carl Gustav Carus TU Dresden
Leipzig, Saxony, Germany, 01307
Actively Recruiting
14
Universitaetsklinikum Schleswig Holstein - Campus Luebeck
Hamburg, Schleswig-Holstein, Germany, 23538
Actively Recruiting
15
Charité - Campus Charité Mitte
Berlin, Germany, 10117
Actively Recruiting
16
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
17
Barts Health NHS Trust
London, Greater London, United Kingdom, E1 1RD
Actively Recruiting
18
Manchester Royal Infirmary
Manchester, Greater Manchester, United Kingdom, M13 9WL
Actively Recruiting
19
Cardiff & Vale University HB
Cardiff, South Glamorgan, United Kingdom, CF14 4XU
Actively Recruiting
20
Frimley Park Hospital
Frimley, Surrey, United Kingdom, GU16 7UJ
Actively Recruiting
21
Birmingham Heartlands Hospital
Birmingham, West Midlands, United Kingdom, B 9 5SS
Actively Recruiting
22
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Actively Recruiting
Research Team
T
Trial Registration Coordinator
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
Frequently Asked Questions
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