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

NCT ID: NCT07009262

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-21
• Study Completion Date: 2025-11-25

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Inapplicable

Intervention Type: OTHER

Inapplicable

Interventions

Inapplicable

Inapplicable

Intervention Type: OTHER

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Hereditary Angioedema Association

UNKNOWN

Sponsor Role: collaborator

KalVista Pharmaceuticals, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

KalVista Investigative Site

Fairfax, Virginia, United States

Countries

United States

Other Identifiers

ICTOS-001

Identifier Type: -

Identifier Source: org_study_id