Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema

What Was Tested

The trial (phase 3) is built around Icatibant.

It had four arms (groups): Icatibant- Randomized (experimental), Placebo-Randomized (placebo comparator), Controlled Open-label / laryngeal attack (experimental) and one (experimental).

Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.

Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.

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

This Phase II/III study consisted of two parts: A controlled phase and An Open label extension(OLE) phase.

Patients experienced a laryngeal attack were not randomised, but treated with open label icatibant according to the controlled phase procedures and assessments.

The outcome of this group was to be reported descriptively.

After treatment of the first attack in the controlled phase, the patients were eligible to enter the OLE phase.

Who Took Part

The registry lists 84 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 complement 1 esterase inhibitor \[C1-INH\] deficiency);. Current edema be in the cutaneous, abdominal and/or laryngeal areas;. Current edema be moderate to severe according to the investigator's Symptom Score.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: diagnosis of angioedema other than hae, for example, acquired angioedema (aae);; 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 edema attack;.

How the Study Was Run

The set-up was randomized, single-group and double-blind.

Because people in this Icatibant study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Icatibant study, the assignments were hidden from both participants and investigators until the end.

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

Those kept unaware of assignments: participant and investigator.

It started in 2004-12-28 with completion listed for 2006-07-17.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to Onset of Symptom Relief (TOSR) (time frame: 5 days).

It also tracked 2 secondary outcomes, 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 84 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.