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

NCT07009262 — Completed, 88 participants, KalVista Pharmaceuticals, Ltd.

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A Prospective, Non-interventional Study in Patients With Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks

Registry	NCT07009262, acronym ICTOS
Status	Completed
Study type	Observational
Enrollment	88 (Actual)
Sponsor	KalVista Pharmaceuticals, Ltd. (Industry); collaborators: US Hereditary Angioedema Association
Conditions	Hereditary Angioedema
Interventions	Inapplicable (Other)
Dates	start 2025-04-21, primary completion 2025-11-25, completion 2025-11-25, first posted 2025-06-06, last updated 2026-01-13
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients with Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks.		Other: Inapplicable

Inapplicable (Other): Inapplicable

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 12 Years to any

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

+Locations (1)

Facility	City	Country	Status
KalVista Investigative Site	Fairfax, Virginia	United States

My Notes

Public

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