Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)

What Was Tested

The trial (phase 3) is built around Icatibant.

Primary Outcome Measures: The primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase.

It had four arms (groups): Randomized controlled -Icatibant (experimental), Randomized controlled-Tranexamic acid (active comparator), Controlled Open-label / laryngeal attack (experimental) and one (experimental).

Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.

The registry classes the interventions as drug.

More on the Plan

The study consisted of two parts: controlled phase and OLE phase.

Who Took Part

85 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: Age above 18 years;. Documented diagnosis of HAE Type I or II (confirmed C1-INH deficiency);. Current edema in the cutaneous, abdominal and/or laryngeal areas;. Current edema moderate to severe according to the investigator's Symptom Score.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: diagnosis of angioedema other than hae,; participation in a clinical trial of another investigational medicinal product (imp)within the past month; treatment with any pain medication since onset of the current angioedema attack.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Icatibant group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Icatibant, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2005-03-01 with completion listed for 2006-07-25.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to Onset of Symptom Relief (time frame: 2 days).

It also tracked 1 secondary outcome, for example Time to Almost Complete Symptom Relief.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Icatibant in 85 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.