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

Recruiting

• Conditions: Hereditary Angioedema

• Registration Number: NCT07009262
• Lead Sponsor: KalVista Pharmaceuticals, Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-21
• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2026-04-07
• Study Completion: 2026-04-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGI-C)	Within 12 hours of the first Icatibant dose adminstration	time to beginning of symptom relief defined as at least ''a little better'' (2 time points in a row)

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Severity (PGI-S)	Within 12 hours of the first Icatibant dose adminstration	Time to first incidence of decrease from baseline (2 time points in a row)
PGI-S: Time to Complete HAE Attack Resolution	Within 24 hours of the first Icatibant dose adminstration	time to HAE attack resolution, defined as ''none''
Return to normal function	At 48 hours after first Icatibant dose adminstration	Time to return to normal daily activities. Date/Time or one of the following options: * Not Applicable - daily activities were not affected; * not yet returned to normal activities
General Anxiety Numeric Rating Scale (GA-NRS): Cumulative GA-NRS	over 12 and 24 hours of the first icatibant administration	Patient is asked 'How anxious do you feel right now?' 11-point numeric scale, 0-10 with 0=Not at all anxious and 10=Extremely anxious

Trial Locations

Locations (1)

KalVista Investigative Site; 🇺🇸 Fairfax, Virginia, United States