OTHER
Inapplicable
Inapplicable
Status
Completed
Phase
Not applicable
Enrollment
88
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
OTHER
Inapplicable
Timeline
First posted
Jun 6, 2025
Study start
Apr 21, 2025
Primary completion
Nov 25, 2025
Study completion
Nov 25, 2025
Results posted
Not reported
Registry updated
Jan 13, 2026
Outcomes
Patient Global Impression of Change (PGI-C)
Time frame · 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)
Patient Global Impression of Severity (PGI-S)
Time frame · 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
Time frame · Within 24 hours of the first Icatibant dose adminstration
time to HAE attack resolution, defined as ''none''
Return to normal function
Time frame · 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
Time frame · 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
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
KalVista Investigative Site
Fairfax, Virginia, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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