RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-21

Study Completion:2026-04-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07009262

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Christine Selva

CONTACT

798-5598

cselva@haea.org

Study Locations (Sites)

KalVista Investigative Site

Fairfax, Virginia, 22030

United States

Collaborators and Investigators

Sponsor: KalVista Pharmaceuticals, Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-21

Study Completion Date2026-04-07

Study Record Updates

Study Start Date2025-04-21

Study Completion Date2026-04-07

Terms related to this study

Additional Relevant MeSH Terms

Hereditary Angioedema