Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE

What Was Tested

The trial (phase 4) is built around Icatibant.

The investigators believe that self administration with Icatibant for treatment of an acute attack of angioedema will not change the time to complete or near complete resolution of symptoms compared to treatment with Icatibant in a medical facility.

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

Open-label study.

The registry classes the interventions as drug.

Who Took Part

19 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Males and females at least 18 years of age at the time of informed consent. Documented diagnosis of hereditary angioedema Type I or II based on ALL of the following criteria:. Family and/or medical history. Characteristic attack manifestations, recurrent attacks. Historical low C4, normal C1q and either low C1-INH or low C1INH function.

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: participation in a clinical therapeutic trial of another investigational medicinal product within the past month (except a previous icatibant study); diagnosis of angioedema other than type i or type ii hereditary angioedema; evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease.

How the Study Was Run

It was run as a single-group and open-label study.

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 2011-12 with completion listed for 2014-04.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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 1 secondary outcome, for example Percent Change in VAS Scores.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Icatibant in 19 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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