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New drug offers hope for rare swelling disorder patients

NCT ID NCT07290855

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called icatibant (Icanticure) in 5 adults with a rare condition that causes sudden, painful swelling attacks. The goal was to see how quickly the drug relieved symptoms and if it was safe. Participants received the injection for free during an acute attack, and researchers tracked their pain and swelling relief over time.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

5 people

The number who actually took part.

Started

Sep 2024

Finished

Sep 2025

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.

Ages

20 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. The male or female patient is ≥20 years old at the time of informed consent. 2. The informed consent form has been read, signed and dated by the patient. 3. At the screening visit, the investigator diagnosed bradykinin-induced angioedema based on at least one of the following: * Recurrent attacks of edema and/or poor respond to antihistamines, corticosteroids or epinephrine * Recurrent angioedema attacks of abdominal, and/or laryngeal (inclusive of laryngeal and pharyngeal) areas * Angioedema without the presence of urticarial rashes * Known family history of angioedema * Known to have genetic defects related to hereditary angioedema 4. Able to communicate well with the investigator, comply with study questionnaires, and other instruments used for collecting patient-reported outcomes. Exclusion Criteria: 1. Known with a history of allergy or hypersensitivity to the investigational drug as judged by the investigator at the screening visit. 2. The patient has a diagnosis of angioedema other than bradykinin induced angioedema. 3. The patient has participated in another clinical study within the past 30 days before screening. 4. Presence of liver disease or liver injury as indicated by an abnormal liver function profile such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin, if any one of them is out of the reference range. The definitions of out of the reference ranges are: * Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), or alkaline phosphatase (ALP) \> 2.5 times ULN (Upper Limit Normal); * Serum total bilirubin \>= 1.5 times ULN; 5. Presence of impaired renal function as indicated by abnormal creatinine or blood urea nitrogen values, if any one of them is out of the reference range. The definitions of out of the reference ranges are: * Creatinine clearance rate (\<= 40 mL/min) (estimated by Cockcroft-Gault formula) and serum creatinine \>=1.5 times ULN; * Blood urea nitrogen value \>= 1.5 times ULN 6. Presence of impaired hematological or coagulation functions as indicated by abnormal measure values, if any one of them is out of the reference range. 7. Evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease. 8. Congestive heart failure (NYHA Class 3 and 4). 9. Stroke within the past 6 months. 10. Known pregnancy and/or breast-feeding. 11. In the opinion of the investigator: mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study. 12. In the opinion of the investigator: unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason. 13. In the opinion of the investigator: inability to manage study medication or self-administration of an injection.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Taichung Veterans General Hospital

    Taichung, Taiwan

More trials for these conditions

Other studies related to the condition(s) this trial covers.