A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks (NCT07009262) | Clinical Trial Compass
CompletedNot Applicable
A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks
United States88 participantsStarted 2025-04-21
Plain-language summary
Patients with HAE Type I or II who enroll in the study are asked to complete a patient diary when they experience an HAE attack. If icatibant is taken as the first treatment for the attack, the patient diary will ask questions over a 48 hour period after dosing to track the characteristics and severity of the attack along with the patient's level of anxiety.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Male or female patients 12 years of age and older
✓. Diagnosis of HAE Type I or II, based on US Hereditary Angioedema Association (HAEA) database records and/or verbal confirmation from the patient
✓. Currently using icatibant to treat HAE attacks
✓. If a patient is receiving long-term prophylactic treatment, they must have been on a stable dose and regimen for at least 3 months prior to the Screening Visit
✓. Patient has had at least 2 HAE attacks in the 3 months prior to the Screening Visit, as self-reported verbally by the patient
✓. Patient is able to read, understand, and complete the eDiary
✓. Patient is willing and able to adhere to all protocol requirements
Exclusion criteria
✕. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1-inhibitor deficiency, HAE with normal C1-INH (previously known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria
✕. Use of angiotensin-converting enzyme inhibitors
✕. Participation in any gene therapy treatment or trial for HAE
✕. Participation in any interventional investigational clinical trial within 4 weeks prior to screening
✕
What they're measuring
1
Patient Global Impression of Change (PGI-C)
Timeframe: Within 12 hours of the first Icatibant dose adminstration