A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)

What Was Tested

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

It had two arms (groups): Placebo (placebo comparator) and Icatibant (experimental).

Single subcutaneous injection of matching placebo.

The registry classes the interventions as drug.

More on the Plan

This Phase III study consisted of two parts: A controlled phase and an open label extension (OLE) phase.

Patients experiencing severe laryngeal attacks (post-amendment) or mild to severe laryngeal attacks (pre-amendment) were to receive open-label icatibant.

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

In the OLE phase, patients who experienced angioedema attacks severe enough to warrant treatment were to be treated with s.c. icatibant as appropriate until the study was discontinued or the product was commercially available.

Who Took Part

The registry lists 98 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: The patient is ≥18 years old at the time of informed consent. The current HAE attack must be in the cutaneous, abdominal and/or laryngeal (inclusive of laryngeal and pharyngeal) areas. Cutaneous or abdominal HAE attacks must be moderate to very severe as determined by investigator global assessment at pre-treatment assessments. The patient must report at least 1 VAS score ≥ 30mm.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: the patient has a diagnosis of angioedema other than hae type i or ii; the patient has received previous treatment with icatibant; the patient has participated in a clinical trial and has received treatment with another investigational medicinal product within the past 30 days.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

The Icatibant group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Icatibant.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-07-16 with completion listed for 2010-10-01.

It ran at 64 sites in United States (39), Russia (7), Ukraine (5), Australia (4), Canada (3) and Israel (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient.

It also tracked 4 secondary outcomes, for example Time to Onset of Primary Symptom Relief and Time to Almost Complete Symptom Relief.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Icatibant in 98 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.