Hereditary Angioedema Clinical Trial
Official title:
A Pharmacokinetic Subtrial in Adolescent Patients With Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial
This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.
| Status | Recruiting |
| Enrollment | 12 |
| Est. completion date | January 30, 2026 |
| Est. primary completion date | January 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 17 Years |
| Eligibility | Inclusion Criteria: - Male or female adolescent patient 12 to 17 years of age at the time of enrollment and during sample collection in this PK subtrial. - Patient is currently participating in KVD900-302. - Patient must provide signed informed consent or assent (when applicable), and a legally authorized representative (LAR) must also provide signed informed consent when applicable. - Patient and LAR are willing and able to provide samples per the requirements of the protocol, including willingness to complete forms and the electronic Diary, obtain and return samples in a timely manner, and obtain samples while within the required age limit. Exclusion Criteria: - Patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | KalVista Investigative Site | Campbelltown | |
| Austria | KalVista Investigative Site | Wien | |
| Bulgaria | KalVista Investigative Site | Sofia | |
| Canada | KalVista Investigative Site | Montréal | |
| France | KalVista Investigative Site | Grenoble Cedex 9 | |
| France | KalVista Investigative Site | Lille | |
| France | KalVista Investigative Site | Lille Cedex | |
| France | KalVista Investigative Site | Paris | |
| Germany | KalVista Investigative Site | Berlin | |
| Germany | KalVista Investigative Site | Frankfurt | |
| Germany | KalVista Investigative Site | Mainz | |
| Germany | KalVista Investigative Site | Morfelden-Walldorf | |
| Greece | KalVista Investigative Site | Athens | |
| Greece | KalVista Investigative Site | Athens | |
| Israel | KalVista Investigative Site | Haifa | |
| Israel | KalVista Investigative Site | Petach Tikvah | |
| Israel | KalVista Investigative Site | Ramat Gan | |
| Israel | KalVista Investigative Site | Tel Aviv | |
| Japan | KalVista Investigative Site | Chiba-shi | |
| Japan | KalVista Investigative Site | Hiroshima-shi | |
| Japan | KalVista Investigative Site | Kawagoe-shi | |
| Japan | KalVista Investigative Site | Maebashi-city | |
| Japan | KalVista Investigative Site | Sapporo-city | Hokkaido |
| Japan | KalVista Investigative Site | Soka-shi | |
| Japan | KalVista Investigative Site | Takatsuki-shi | |
| Japan | KalVista Investigative Site | Tokyo | |
| Japan | KalVista Investigative Site | Yokohama-shi | |
| Netherlands | KalVista Investigative Site | Amsterdam | |
| New Zealand | KalVista Investgative Site | Auckland | |
| Romania | KalVista Investigative Site | Sângeorgiu De Mures | |
| Slovakia | KalVista Investigative Site | Martin | |
| South Africa | KalVista Investigative Site | Cape Town | |
| Spain | KalVista Investigative Site | Barcelona | |
| Spain | KalVista Investigative Site | Barcelona | |
| Spain | KalVista Investigative Site | Madrid | |
| United Kingdom | KalVista Investigative Site | Birmingham | |
| United Kingdom | KalVista Investigative Site | Cambridge | |
| United Kingdom | KalVista Investigative Site | Cardiff | |
| United Kingdom | KalVista Investgative Site | Frimley | |
| United Kingdom | KalVista Investigative Site | Leeds | |
| United Kingdom | KalVista Investigative Site | London | |
| United Kingdom | KalVista Investigative Site | London | |
| United States | KalVista Investigative Site | Centennial | Colorado |
| United States | KalVista Investigative Site | Charlotte | North Carolina |
| United States | KalVista Investigative Site | Chevy Chase | Maryland |
| United States | KalVista Investigative Site | Cincinnati | Ohio |
| United States | KalVista Investigative Site | Colorado Springs | Colorado |
| United States | KalVista Investigative Site | Dallas | Texas |
| United States | KalVista Investigative Site | Evansville | Indiana |
| United States | Kalvista Investigative Site | Hershey | Pennsylvania |
| United States | KalVista Investigative Site | Layton | Utah |
| United States | KalVista Investigative Site | Little Rock | Arkansas |
| United States | KalVista Investigative Site | Louisville | Kentucky |
| United States | KalVista Investigative Site | Overland Park | Kansas |
| United States | KalVista Investigative Site | Plymouth | Minnesota |
| United States | KalVista Investigative Site | Saint Louis | Missouri |
| United States | KalVista Investigative Site | San Diego | California |
| United States | KalVista Investigative Site | San Diego | California |
| United States | KalVista Investigative Site | Santa Monica | California |
| United States | KalVista Investigative Site | Scottsdale | Arizona |
| United States | KalVista Investigative Site | Spokane | Washington |
| United States | KalVista Investigative Site | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| KalVista Pharmaceuticals, Ltd. |
United States, Australia, Austria, Bulgaria, Canada, France, Germany, Greece, Israel, Japan, Netherlands, New Zealand, Romania, Slovakia, South Africa, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pharmacokinetics - Cmax | Up to 6 hours after IMP administration | ||
| Primary | Pharmacokinetics - Tmax | Up to 6 hours after IMP administration | ||
| Primary | Pharmacokinetics - AUC | Up to 6 hours after IMP administration |
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