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New HAE drug garadacimab tested in real life: will it hold up?

NCT ID NCT07001280

Disease control Sponsor: CSL Behring Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 200 people with hereditary angioedema (HAE) who are starting garadacimab in routine medical care. Researchers will track how well the drug prevents swelling attacks, its safety, and its impact on quality of life over 48 months. The goal is to see if results from earlier clinical trials hold true in everyday practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
garadacimab
What this could lead to
If successful, this study could confirm that garadacimab works well in everyday life for preventing HAE attacks, supporting its broader use.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It also relies on patient-reported data, which can be less reliable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants with the diagnosis of HAE and who will initiate garadacimab treatment per routine clinical practice will be enrolled.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

angioedema hereditary angioedema hereditary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hereditary angioedemas

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

  • Asthma and Allergy Wellness Center

    RECRUITING

    Saint Charles, Illinois, 60175-4827, United States

  • Barts Health NHS Trust

    RECRUITING

    London, Greater London, E1 1RD, United Kingdom

  • Birmingham Heartlands Hospital

    RECRUITING

    Birmingham, West Midlands, B 9 5SS, United Kingdom

  • Cardiff & Vale University HB

    RECRUITING

    Cardiff, South Glamorgan, CF14 4XU, United Kingdom

  • Charité - Campus Charité Mitte

    RECRUITING

    Berlin, 10117, Germany

    Contact Email: •••••@•••••

  • Family Allergy and Asthma

    NOT_YET_RECRUITING

    Louisville, Kentucky, 40217, United States

  • Frimley Park Hospital

    RECRUITING

    Frimley, Surrey, GU16 7UJ, United Kingdom

  • HZRM Haemophilie-Zentrum Rhein Main

    ACTIVE_NOT_RECRUITING

    Frankfurt am Main, Hesse, 60596, Germany

  • John Hopkins University

    ACTIVE_NOT_RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kepler Universitätsklinikum - Med Campus III.

    RECRUITING

    Linz, 4021, Austria

  • Leeds Teaching Hospitals NHS Trust

    RECRUITING

    Leeds, West Yorkshire, LS9 7TF, United Kingdom

  • Manchester Royal Infirmary

    RECRUITING

    Manchester, Greater Manchester, M13 9WL, United Kingdom

  • Medical Research of Arizona

    RECRUITING

    Phoenix, Arizona, 85248, United States

  • Medizinische Hochschule Hannover

    ACTIVE_NOT_RECRUITING

    Hanover, Lower Saxony, 30625, Germany

  • Providence Health Care Society

    RECRUITING

    Vancouver, British Columbia, V6Z 2K5, Canada

  • Riverside Medical Group, Belleville

    RECRUITING

    Belleville, New Jersey, 07109, United States

  • Sirven and Associates

    RECRUITING

    Miami, Florida, 33183, United States

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    RECRUITING

    Leipzig, Saxony, 01307, Germany

  • Universitaetsklinikum Schleswig Holstein - Campus Luebeck

    RECRUITING

    Hamburg, Schleswig-Holstein, 23538, Germany

  • Universitaetsklinikum Ulm

    RECRUITING

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Washington University

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63141, United States