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

Phase 3

Recruiting

• Conditions: Hereditary Angioedema
• Interventions: Drug: KVD900 600 mg

• Registration Number: NCT05511922
• Lead Sponsor: KalVista Pharmaceuticals, Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-23
• Study Start: 2022-10-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

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Exclusion Criteria

• Patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KVD900 600 mg	KVD900 600 mg	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics - Tmax	Up to 6 hours after IMP administration
Pharmacokinetics - Cmax	Up to 6 hours after IMP administration
Pharmacokinetics - AUC	Up to 6 hours after IMP administration

Trial Locations

Locations (3)

KalVista Investigative Site; 🇬🇧 London, United Kingdom

Kalvista Investigative Site; 🇺🇸 Hershey, Pennsylvania, United States

KalVista Investgative Site; 🇬🇧 Frimley, United Kingdom