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Investigating KVD900 in adolescents with Hereditary Angioedema

A Pharmacokinetic Subtrial in Adolescent Patients With Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial

Phase 3 Interventional KalVista Pharmaceuticals, Ltd. · NCT05511922

This study is testing how the drug KVD900 works in the bodies of teenagers with Hereditary Angioedema to see if it's safe and effective for them.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment12 (estimated)
Ages12 Years to 17 Years
SexAll
SponsorKalVista Pharmaceuticals, Ltd. Industry-sponsored
Locations62 sites (Scottsdale, Arizona and 61 other locations)
Trial IDNCT05511922 on ClinicalTrials.gov

What this trial studies

This multicenter pharmacokinetic subtrial focuses on evaluating the pharmacokinetic profile of KVD900 (sebetralstat) in adolescent patients aged 12 to 17 who have Hereditary Angioedema (HAE) type I or II. Participants must be enrolled in the KVD900-302 trial and will receive either a 600 mg or 300 mg dose of KVD900. The study aims to gather data on how the drug is processed in the body, which is crucial for understanding its effectiveness and safety in this age group.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12 to 17 with a diagnosis of Hereditary Angioedema type I or II who are currently participating in the KVD900-302 trial.

Not a fit: Patients with a history of bleeding disorders or those currently taking anticoagulant or antiplatelet medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for adolescents suffering from Hereditary Angioedema.

How similar studies have performed: While this specific pharmacokinetic subtrial is novel, similar studies investigating the pharmacokinetics of treatments for Hereditary Angioedema have shown promising results.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Scottsdale, Arizona and 61 other locations

+12 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hereditary AngioedemaKONFIDENT-SSebetralstat
Last reviewed 2026-06-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.