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

NCT07009262 | Completed

• 1 other identifier: ICTOS-001
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Hereditary Angioedema

Outcome Measures

Primary Outcomes (1)

• Patient Global Impression of Change (PGI-C)

  time to beginning of symptom relief defined as at least ''a little better'' (2 time points in a row)

  Within 12 hours of the first Icatibant dose adminstration

Secondary Outcomes (4)

• Patient Global Impression of Severity (PGI-S)

  Within 12 hours of the first Icatibant dose adminstration

• PGI-S: Time to Complete HAE Attack Resolution

  Within 24 hours of the first Icatibant dose adminstration

• Return to normal function

  At 48 hours after first Icatibant dose adminstration

• General Anxiety Numeric Rating Scale (GA-NRS): Cumulative GA-NRS

  over 12 and 24 hours of the first icatibant administration

Study Arms (1)

Patients with Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks.

Other: Inapplicable

Interventions

Inapplicable OTHER

Inapplicable

Patients with Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a self-reported diagnosis of HAE Type I or II who take icatibant to treat HAE attacks

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

Sponsors & Collaborators

• KalVista Pharmaceuticals, Ltd.: lead
• US Hereditary Angioedema Association: collaborator

Study Sites (1)

KalVista Investigative Site

Fairfax, Virginia, 22030, United States

Location

MeSH Terms

Conditions

Angioedemas, Hereditary

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: June 6, 2025
• Study Start: April 21, 2025
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)