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

Recruiting
12 - 17 years of age
Both
Phase 3

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Overview

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.

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.

Study details

Hereditary Angioedema

NCT05511922

KalVista Pharmaceuticals, Ltd.

22 March 2024

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