A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants

What Was Tested

The trial (phase 3) is built around Icatibant.

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

The registry classes the interventions as drug.

Who Took Part

8 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 participant is in Japan and is Japanese; defined as born in Japan and having Japanese parents and Japanese maternal and paternal grandparents. The participant is male or female and greater than or equal to (\>=) 18 years of age at the time of informed consent. The participant has a confirmed diagnosis of hereditary angioedema (HAE) type I or II. Diagnosis may be based on historical data using the following criteria:. Family history of angioedema. Characteristic attack manifestations, recurrent attacks.

The full record lists 17 inclusion and 12 exclusion criteria; among the exclusions: the participant will require an intervention to support the airway (example: intubation, tracheotomy, cricothyrotomy) due to the current attack of angioedema; the participant has a diagnosis of angioedema other than hae (non-hereditary angioedema, example: acquired angioedema); the participant has received previous treatment with icatibant.

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 2015-03-18 with completion listed for 2016-02-12.

It ran at 8 sites in Japan (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to Onset of Symptom Relief (TOSR) (time frame: Baseline up to 120 hours post-treatment).

It also tracked 17 secondary outcomes, for example Time to Onset of Primary Symptom Relief (TOSR-P), Change From Baseline in the Composite Visual Analog Scale (VAS) Score, Composite Symptom Score (SS) Assessed by Investigator, Composite Symptom Score (SS) Assessed by Participant, Investigator Global Assessment and Time to Almost Complete Symptom Relief As Assessed by Visual Analog Scale (VAS) Score.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Icatibant in 8 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.