Hereditary Angioedema
Conditions
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.
Interventions
OTHERInapplicable
Inapplicable
Sponsors
US Hereditary Angioedema Association
KalVista Pharmaceuticals, Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change (PGI-C) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Severity (PGI-S) | 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 | Within 24 hours of the first Icatibant dose adminstration | time to HAE attack resolution, defined as ''none'' |
| Return to normal function | 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 | 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 |
Countries
United States
Outcome results
None listed