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This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 (sebetralstat) in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KVD900 600 mg | Experimental |
| |
| Experimental: KVD900 300 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 |
|---|---|---|
| Pharmacokinetics - Cmax | Up to 6 hours after IMP administration | |
| Pharmacokinetics - Tmax | Up to 6 hours after IMP administration | |
| Pharmacokinetics - AUC | Up to 6 hours after IMP administration |
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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 | Scottsdale | Arizona | 85251 | United States | ||
| KalVista Investigative Site |
Data will not be shared until all global regulatory filings are complete.
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| Drug: KVD900 300 mg |
| Drug |
KVD900 Tablet 300 mg |
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| KalVista Investigative Site | San Diego | California | 92122 | United States |
| KalVista Investigative Site | San Diego | California | 92123 | United States |
| KalVista Investigative Site | Santa Monica | California | 90404 | United States |
| KalVista Investigative Site | Centennial | Colorado | 80112 | United States |
| KalVista Investigative Site | Colorado Springs | Colorado | 80907 | United States |
| KalVista Investigative Site | Evansville | Indiana | 47715 | United States |
| KalVista Investigative Site | Overland Park | Kansas | 66211 | United States |
| KalVista Investigative Site | Louisville | Kentucky | 40215 | United States |
| KalVista Investigative Site | Chevy Chase | Maryland | 20815 | United States |
| KalVista Investigative Site | Plymouth | Minnesota | 55446 | United States |
| KalVista Investigative Site | St Louis | Missouri | 63141 | United States |
| KalVista Investigative Site | Charlotte | North Carolina | 28277 | United States |
| KalVista Investigative Site | Cincinnati | Ohio | 45236 | United States |
| KalVista Investigative Site | Toledo | Ohio | 43617 | United States |
| Kalvista Investigative Site | Hershey | Pennsylvania | 17033 | United States |
| KalVista Investigative Site | Dallas | Texas | 75231 | United States |
| KalVista Investigative Site | Layton | Utah | 84041 | United States |
| KalVista Investigative Site | Spokane | Washington | 99204 | United States |
| KalVista Investigative Site | Campbelltown | 2560 | Australia |
| KalVista Investigative Site | Vienna | 1090 | Austria |
| KalVista Investigative Site | Sofia | 1431 | Bulgaria |
| KalVista Investigative Site | Montreal | H2W 1R7 | Canada |
| KalVista Investigative Site | Grenoble | 38043 | France |
| KalVista Investigative Site | Lille | 59037 | France |
| KalVista Investigative Site | Paris | 75012 | France |
| KalVista Investigative Site | Berlin | 12203 | Germany |
| KalVista Investigative Site | Frankfurt | 60590 | Germany |
| KalVista Investigative Site | Mainz | 55131 | Germany |
| KalVista Investigative Site | Mörfelden-Walldorf | 64546 | Germany |
| KalVista Investigative Site | Athens | 11521 | Greece |
| KalVista Investigative Site | Athens | 11527 | Greece |
| KalVista Investigative Site | Haifa | 31048 | Israel |
| KalVista Investigative Site | Petach Tikvah | 4920235 | Israel |
| KalVista Investigative Site | Ramat Gan | 52621 | Israel |
| KalVista Investigative Site | Tel Aviv | 64239 | Israel |
| KalVista Investigative Site | Sapporo | Hokkaido | 002-8072 | Japan |
| KalVista Investigative Site | Chiba | 260-8677 | Japan |
| KalVista Investigative Site | Hiroshima | 730-8518 | Japan |
| KalVista Investigative Site | Kawagoe-shi | 350-8550 | Japan |
| KalVista Investigative Site | Maebashi | 371-8511 | Japan |
| KalVista Investigative Site | Soka-shi | 340-0041 | Japan |
| KalVista Investigative Site | Takatsuki-shi | 569-8686 | Japan |
| KalVista Investigative Site | Tokyo | 142-8666 | Japan |
| KalVista Investigative Site | Yokohama | 236-0004 | Japan |
| KalVista Investigative Site | Amsterdam | 1105 AZ | Netherlands |
| KalVista Investgative Site | Auckland | 1023 | New Zealand |
| KalVista Investigative Site | Sângeorgiu de Mureş | 547530 | Romania |
| KalVista Investigative Site | Martin | 036 59 | Slovakia |
| KalVista Investigative Site | Cape Town | 7700 | South Africa |
| KalVista Investigative Site | Barcelona | 08035 | Spain |
| KalVista Investigative Site | Barcelona | 08907 | Spain |
| KalVista Investigative Site | Madrid | 28046 | Spain |
| KalVista Investigative Site | Birmingham | B9 5SS | United Kingdom |
| KalVista Investigative Site | Cambridge | CB2 0QQ | United Kingdom |
| KalVista Investigative Site | Cardiff | CF14 4XW | United Kingdom |
| KalVista Investgative Site | Frimley | GU16 7UJ | United Kingdom |
| KalVista Investigative Site | Leeds | LS9 7TF | United Kingdom |
| KalVista Investigative Site | London | E1 2ES | United Kingdom |
| KalVista Investigative Site | London | NW3 2QG | United Kingdom |
| 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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