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PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial

NCT05511922

CompletedPhase 3

Sponsor: KalVista Pharmaceuticals, Ltd.

Conditions: Hereditary Angioedema

Interventions: KVD900 600 mg, Drug: KVD900 300 mg

Countries: United States, Australia, Austria, Bulgaria, Canada, France, Germany, Greece

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (61)
  • Scottsdale, Arizona, United States
  • Little Rock, Arkansas, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • Santa Monica, California, United States
  • Centennial, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Evansville, Indiana, United States
  • Overland Park, Kansas, United States
  • Louisville, Kentucky, United States
  • Chevy Chase, Maryland, United States
  • Plymouth, Minnesota, United States
  • St Louis, Missouri, United States
  • Charlotte, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Toledo, Ohio, United States
  • Hershey, Pennsylvania, United States
  • Dallas, Texas, United States
  • Layton, Utah, United States
  • Spokane, Washington, United States
  • Campbelltown, Australia
  • Vienna, Austria
  • Sofia, Bulgaria
  • Montreal, Canada
  • Grenoble, France
  • Lille, France
  • Paris, France
  • Berlin, Germany
  • Frankfurt, Germany
  • Mainz, Germany
  • + 31 more on CT.gov