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KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150 mg Dose Group | Other | Patients will take a single 150 mg dose of KVD900. |
|
| 300 mg Dose Group | Other | Patients will take a single 300 mg dose of KVD900. |
|
| 600 mg Dose Group | Other | Patients will take a single 600 mg dose of KVD900. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KVD900 150 mg | Drug | KVD900 Tablet 150 mg (2 x 75 mg) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of pediatric patients with HAE Types I or II who take any sebetralstat dose, who experience any AE(s) (including fatal AEs) during the study, irrespective of uses of other medications and sebetralstat discontinuations for any reason. | Throughout the duration of the trial, up to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Global Impression of Change (CaGI-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 IMP administration. | |
| Caregiver Global Impression of Severity (CaGI-S): Time to first incidence of decrease from baseline (2 time points in a row) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | KalVista Pharmaceuticals, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KalVista Investigative Site | Birmingham | Alabama | 35209 | United States | ||
| KalVista Investigative Site |
Data will not be shared until all global regulatory filings are complete.
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| KVD900 300 mg |
| Drug |
KVD900 Tablet 300 mg (1 x 300 mg) |
|
| KVD900 600 mg | Drug | KVD900 Tablet 600 mg (2 x 300 mg) |
|
| Within 12 hours of the first IMP administration. |
| CaGI-S: Time to HAE attack resolution defined as "none" | Within 24 hours of the first IMP administration |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| KalVista Investigative Site | San Diego | California | 92123 | United States |
| KalVista Investigative Site | Santa Monica | California | 90404 | United States |
| KalVista Investigative Site | Evansville | Indiana | 47715 | United States |
| KalVista Investigative Site | Wheaton | Maryland | 20902 | United States |
| KalVista Investigative Site | St Louis | Missouri | 63141 | United States |
| KalVista Investigative Site | Toledo | Ohio | 43560 | United States |
| KalVista Investigative Site | Hershey | Pennsylvania | 17011 | United States |
| KalVista Investigative Site | Dallas | Texas | 75231 | United States |
| KalVista Investigative Site | Edmonton | Alberta | T6G 2B7 | Canada |
| KalVista Investigative Site | Lille | 59000 | France |
| KalVista Investigative Site | Marseille | 13005 | France |
| KalVista Investigative Site | Paris | 75012 | France |
| KalVista Investigative Site | Frankfurt am Main | 60590 | Germany |
| KalVista Investigative Site | Frankfurt am Main | 60596 | Germany |
| KalVista Investigative Site | Haifa | 31048 | Israel |
| KalVista Investigative Site | Petah Tikva | 4920235 | Israel |
| KalVista Investigative Site | Tel Aviv | 6423906 | Israel |
| KalVista Investigative Site | Milan | 20097 | Italy |
| KalVista Investigative Site | Padova | 35128 | Italy |
| KalVista Investigative Site | Rome | 00133 | Italy |
| KalVista Investigative Site | Kawagoe | 350-8550 | Japan |
| KalVista Investigative Site | Tokyo | 113-8431 | Japan |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 8, 2026 | Jul 1, 2026 | 15 |
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
| 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 |
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| ID | Term |
|---|---|
| C000726128 | sebetralstat |
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