EASSI - Evaluation of the Safety of Self-Administration With Icatibant

What Was Tested

In this phase 3 trial, researchers set out to test Icatibant.

It had two arms (groups): Icatibant- Naive Treatment Phase (experimental) and icatibant- Self administration Phase (experimental).

The registry classes the interventions as drug.

More on the Plan

Subjects with a documented diagnosis of HAE Type I or II were eligible to participate in this trial.

Eligible subjects included those who had received treatment for HAE with icatibant in previous clinical trials, or subjects who had been previously treated with the marketed product Firazyr® and subjects who were naïve to icatibant treatment.

Comprehensive educational material and instructions including pictograms were developed for the subjects to illustrate the method of self-administration and use of the Patient Diary.

The training material provided additional information on how to self-diagnose an HAE attack and how to decide on the necessity to treat.In addition, instructions were provided on what to do in case of a laryngeal attack.

Who Took Part

151 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 18 years of age at the time of informed consent. Documented diagnosis of HAE Type I or II based on ALL of the following criteria:. Family and/or medical history. Characteristic attack manifestations, recurrent attacks. Mental and physical condition allowing patients to complete baseline assessment, to self-administer icatibant and to follow other study procedures.

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: participation in a clinical 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 hae; 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

The set-up was non-randomized, 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 2009-09-25 with completion listed for 2011-06-22.

It ran at 26 sites in France (5), Germany (4), Spain (4), Israel (3), United Kingdom (3) and Italy (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant (time frame: 7 days from the beginning of each phase).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Icatibant in 151 people.

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.