A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE)
NCT ID: NCT07001280
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-07-21
2030-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Garadacimab
This cohort will include all participants diagnosed with HAE and who will be prescribed garadacimab treatment as per routine clinical practice.
No intervention
No intervention will be administered as part of this study.
Interventions
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No intervention
No intervention will be administered as part of this study.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Global Program Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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Medical Research of Arizona
Phoenix, Arizona, United States
John Hopkins University
Baltimore, Maryland, United States
Washington University
St Louis, Missouri, United States
Riverside Medical Group, Belleville
Belleville, New Jersey, United States
HZRM Haemophilie-Zentrum Rhein Main
Frankfurt am Main, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Leipzig, Saxony, Germany
Universitaetsklinikum Schleswig Holstein - Campus Luebeck
Hamburg, Schleswig-Holstein, Germany
Charité - Campus Charité Mitte
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSL312_4001
Identifier Type: -
Identifier Source: org_study_id
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