An observational study in Hereditary Angioedemas, sponsored by CSL Behring. Recruiting at 22 sites in 5 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by CSL Behring (part of CSL Limited) · 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-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.
171 studies on the registry are indexed under Angioedemas, Hereditary; 24 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 43 observational studies indexed under Angioedemas, Hereditary.
Browse Angioedemas, Hereditary studies →CSL Behring is the lead sponsor of 145 studies on the registry; 17 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.
First submitted after CSL Behring became part of CSL Limited.
Counted across the registry records on this site, refreshed daily.
Participants with the diagnosis of HAE and who will initiate garadacimab treatment per routine clinical practice will be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort will include all participants diagnosed with HAE and who will be prescribed garadacimab treatment as per routine clinical practice.
Other: No intervention
No intervention will be administered as part of this study.
Incidence Rate Ratio (IRR) of HAE Attacks
Monthly HAE attack rate while on treatment with garadacimab, including all HAE attacks, HAE attacks requiring acute treatment (on demand therapy \[ODT\]), and by severity will be reported. All HAE attacks will be categorized by severity as: Mild (no impact on daily life), Moderate (some impact on daily life), and Severe (severe impact on daily life).
Time frame: Up to 24 months
Number of Participants with Adverse Events (AEs), Severity of AEs, Serious AEs (SAEs), and Treatment-related AEs
Time frame: Up to 48 months
Change From Baseline in Angioedema Control Test (AECT) Total Score
The AECT includes a set of 4 AECT items attributable to the domains of signs and symptoms, impact and effectiveness of treatment, and the 4th item addresses the important aspect of unpredictability, which correlates strongly with anxiety and fears of recurrent angioedema patients. Score ranges from 0 (minimum) to 16 (maximum). A higher score indicates a higher level of angioedema control.
Time frame: Baseline to 48 months
Change From Baseline in Angioedema Quality of Life Questionnaire (AE-QoL) Total Score
The AE-QoL includes 17 items across 4 domains: functioning (4 items), fatigue/mood (5 items), fears/shame (6 items), and food (2 items). Total scores range from 0 to 100, where 100 indicates the worst possible impairment of health related QoL.
Time frame: Baseline to 48 months
Percentage of Participants With Reduction in Monthly HAE Attacks and who Achieved HAE Attack-free Status
Time frame: Up to Month 24
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Plan to share: No
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Aug 2028, 37 months after the start.
Of 27 observational studies under Angioedemas, Hereditary, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 56. This study's planned 37 months is below that.
How these figures are worked out, and which studies are left out of them.
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