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| Name | Class |
|---|---|
| US Hereditary Angioedema Association | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Type I or II Hereditary Angioedema Using Icatibant for On-demand Treatment of Attacks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inapplicable | Other | Inapplicable |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGI-C) | time to beginning of symptom relief defined as at least ''a little better'' (2 time points in a row) | Within 12 hours of the first Icatibant dose adminstration |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Severity (PGI-S) | Time to first incidence of decrease from baseline (2 time points in a row) | Within 12 hours of the first Icatibant dose adminstration |
| PGI-S: Time to Complete HAE Attack Resolution |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a self-reported diagnosis of HAE Type I or II who take icatibant to treat HAE attacks
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KalVista Investigative Site | Fairfax | Virginia | 22030 | United States |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing but only after deidentification of individual patient data.
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| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
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time to HAE attack resolution, defined as ''none''
| Within 24 hours of the first Icatibant dose adminstration |
| Return to normal function | Time to return to normal daily activities. Date/Time or one of the following options:
| At 48 hours after first Icatibant dose adminstration |
| General Anxiety Numeric Rating Scale (GA-NRS): Cumulative GA-NRS | 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 | over 12 and 24 hours of the first icatibant administration |
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |