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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
United States
Virginia
KalVista Investigative Site
RECRUITING
Fairfax
Contact Information
Primary
Christine Selva
cselva@haea.org
798-5598
Time Frame
Start Date: 2025-04-21
Estimated Completion Date: 2026-04-07
Participants
Target number of participants: 50
Treatments
Patients with Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks.
Related Therapeutic Areas
Sponsors
Leads: KalVista Pharmaceuticals, Ltd.
Collaborators: US Hereditary Angioedema Association

This content was sourced from clinicaltrials.gov