CompletedPhase 3

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

United States, Australia, Austria11 participantsStarted 2022-10-24

Plain-language 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.

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pharmacokinetics - Cmax

Timeframe: Up to 6 hours after IMP administration

Pharmacokinetics - Tmax

Timeframe: Up to 6 hours after IMP administration

Pharmacokinetics - AUC

Timeframe: Up to 6 hours after IMP administration

Trial details

NCT IDNCT05511922

SponsorKalVista Pharmaceuticals, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-27

View on ClinicalTrials.gov More Hereditary Angioedema trials

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.