A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema

What Was Tested

In this phase 4 trial, researchers set out to test Icatibant.

This is a phase IV clinical study.

The investigators collect patients with a diagnosis of bradykinin induced angioedema.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 5 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: The male or female patient is ≥20 years old at the time of informed consent. The informed consent form has been read, signed and dated by the patient. 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.

The full record lists 9 inclusion and 17 exclusion criteria; among the exclusions: known with a history of allergy or hypersensitivity to the investigational drug as judged by the investigator at the screening visit; the patient has a diagnosis of angioedema other than bradykinin induced angioedema; the patient has participated in another clinical study within the past 30 days before screening.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Icatibant study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-09-27 with completion listed for 2025-05-27.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To evaluate the time to complete or near complete resolution from onset of symptoms (time frame: Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours).

It also tracked 3 secondary outcomes, for example Percent Change in VAS pain score: VAS scale ranges from 0-10 with 0 being no any pain and 10 being the highest severity in pain and To evaluate volume change of edema from onset of symptoms to complete or near complete resolution.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Icatibant in 5 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Icatibant compound page, all human trials.