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This is a Phase 4, prospective, open-label trial to evaluate the safety and effectiveness of sebetralstat when used for STP for a qualifying procedures in patients 12 years of age or older with hereditary angioedema (HAE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KVD900 600 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KVD900 600 mg | Drug | KVD900 Tablet 600 mg (2 x 300 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number and proportion of STPs that did not result in an HAE attack within 24 hours after the start of the procedure will be summarized. | 24 hours following the start of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KalVista Pharmaceuticals | Contact | 1 (857) 999-0075 | clinicalstudies@kalvista.com |
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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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| ID | Term |
|---|---|
| C000726128 | sebetralstat |
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| 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 |