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Each trial has specific eligibility criteria including age, condition, medical history, and current treatments. TrialConnect shows you trials that may match your situation, but only the trial team can confirm eligibility.

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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Health checks and monitoring — no treatment given
Type of study: Observational (no treatment given)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: No intervention (other)
How long the study runs: Study runs about 61 months (dates as stated)
About the drug or intervention: No intervention — other: No intervention will be administered as part of this study.
Patient visit burden: Not specified by the sponsor

In plain English

This study looks at how well garadacimab works and how safe it is for people with hereditary angioedema (HAE), a condition causing sudden swelling. CSL Behring is running the study.

Who can take part

Aged 12 or over at enrolment.
Have a confirmed diagnosis of HAE, based on symptoms and/or test results.
Are newly starting garadacimab, prescribed by their doctor as part of normal care and according to the approved label, before joining the study.
Are willing and able to give written informed consent (a parent or legal guardian gives consent for those under 18, or under the legal age of consent in their country).
Can use an electronic device such as a smartphone or computer to record study information.

Who may not be able to

Have another type of angioedema, such as idiopathic or acquired angioedema, or recurring swelling linked to hives (histaminergic angioedema).
Are taking part in any ongoing interventional clinical study, including studies of garadacimab. People who join such a study later will be withdrawn from this one.

What taking part involves

• Taking garadacimab as newly prescribed by your doctor, in line with the approved label — not as a new or experimental treatment given by the study.
• Using an electronic device such as a smartphone or computer to collect study data.

Time commitment: Number of visits and study duration: Not stated — ask the trial team. Taking part involves recording information on an electronic device.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Observing health over time
Ages: 12 Years and over
Who: All
Number of participants: 200
Started: 2025-07-21
Last checked: 2026-05

Plain English Summary

What is this study?

• Testing a new treatment for hereditary angioedemas
• Clinical study - 200 participants
• This is a multinational, multicenter, prospective, observational cohort study of patients with HAE in the real-world setting

Who can take part?

• Ages 12 Years and over
• Diagnosed with hereditary angioedemas

Where?

• Cambridge - Addenbrooke's Hospital
• London - Barts Health NHS Trust
• Manchester - Manchester Royal Infirmary
• Cardiff - Cardiff & Vale University HB
• +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Hereditary Angioedemas

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 12 Years and over
Who can join: All genders

What the study is looking for

✓1\. Participants aged greater than or equal to (\>=) 12 years at enrollment.
✓2\. Participants with clinical and/or laboratory confirmed diagnosis of HAE.
✓4\. Willing and able to provide written agreement to take part and/or assent by parent or legal guardian for children less...
✓5\. Ability to use an electronic device such as a smartphone or a computer for data collection in the study.

Who cannot take part

✗1\. Participants with a concomitant diagnosis of another form of angioedema such as idiopathic or acquired...

See the full 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.