A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks

Launched by KALVISTA PHARMACEUTICALS, LTD. · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well icatibant, a medication used to treat attacks of Hereditary Angioedema (HAE) Type I or II, works for patients in the U.S. If you decide to participate, you'll keep a diary to record your experiences during an HAE attack, especially if icatibant is your first treatment. The diary will help track how severe the attack is and how it affects your anxiety over a 48-hour period after taking the medication.

To be eligible for this study, you need to be at least 12 years old and have a confirmed diagnosis of HAE Type I or II. You should be currently using icatibant for your attacks and have experienced at least two attacks in the last three months. If you meet these criteria and are willing to follow the study's requirements, you could contribute valuable information about managing HAE. Participants will be guided on how to complete the diary and can expect to share their experiences to help improve treatments for HAE in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients 12 years of age and older
• • 2. Diagnosis of HAE Type I or II, based on US Hereditary Angioedema Association (HAEA) database records and/or verbal confirmation from the patient
• • 3. Currently using icatibant to treat HAE attacks
• • 4. 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
• • 5. Patient has had at least 2 HAE attacks in the 3 months prior to the Screening Visit, as self-reported verbally by the patient
• • 6. Patient is able to read, understand, and complete the eDiary
• • 7. Patient is willing and able to adhere to all protocol requirements
• Exclusion Criteria:
• • 1. 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
• • 2. Use of angiotensin-converting enzyme inhibitors
• • 3. Participation in any gene therapy treatment or trial for HAE
• • 4. Participation in any interventional investigational clinical trial within 4 weeks prior to screening
• • 5. Any pregnant or breastfeeding patient