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

KalVista Pharmaceuticals

Status and phase: Active, not recruiting; Phase 3

Conditions: Hereditary Angioedema

Treatments: Drug: Drug: KVD900 300 mg; Drug: KVD900 600 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05511922

KVD900-302a

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

KVD900 600 mg

Experimental group

Treatment:

Drug: KVD900 600 mg

Experimental: KVD900 300 mg

Experimental group

Treatment:

Drug: Drug: KVD900 300 mg