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Completed NCT05511922

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

Conditions: Hereditary Angioedema

Sex: All
Ages: 12 Years – 17 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 11
Sponsor: KalVista Pharmaceuticals, Ltd.

Location: KalVista Investigative Site Scottsdale Arizona

Summary

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 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05511922). StuddyBuddy aggregates publicly available trial information.