A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks
Completed
Conditions studied: Hereditary Angioedema
In brief
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.
Key facts
- Study ID
- NCT07009262
- Run by
- KalVista Pharmaceuticals, Ltd.
- People needed
- 88
- Starts
- 2025-04-21
- Expected to finish
- 2025-11-25
- Last updated by the study team
- 2026-01-13
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Any pregnant or breastfeeding patient
Where it is running
- KalVista Investigative Site — Fairfax, Virginia, United States
Full record on ClinicalTrials.gov
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