PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Hereditary Angioedema
Спонсор: KalVista Pharmaceuticals, Ltd.
Налично на:
БГ
Обобщение
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.
Кой може да участва
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.