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

June 4, 2026 updated by: KalVista Pharmaceuticals, Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Campbelltown, Australia, 2560
        • KalVista Investigative Site
  • Austria
      • Vienna, Austria, 1090
        • KalVista Investigative Site
  • Bulgaria
      • Sofia, Bulgaria, 1431
        • KalVista Investigative Site
  • Canada
      • Montreal, Canada, H2W 1R7
        • KalVista Investigative Site
  • France
      • Grenoble, France, 38043
        • KalVista Investigative Site
      • Lille, France, 59037
        • KalVista Investigative Site
      • Paris, France, 75012
        • KalVista Investigative Site
  • Germany
      • Berlin, Germany, 12203
        • KalVista Investigative Site
      • Frankfurt, Germany, 60590
        • KalVista Investigative Site
      • Mainz, Germany, 55131
        • KalVista Investigative Site
      • Mörfelden-Walldorf, Germany, 64546
        • KalVista Investigative Site
  • Greece
      • Athens, Greece, 11521
        • KalVista Investigative Site
      • Athens, Greece, 11527
        • KalVista Investigative Site
  • Israel
      • Haifa, Israel, 31048
        • KalVista Investigative Site
      • Petach Tikvah, Israel, 4920235
        • KalVista Investigative Site
      • Ramat Gan, Israel, 52621
        • KalVista Investigative Site
      • Tel Aviv, Israel, 64239
        • KalVista Investigative Site
  • Japan
      • Chiba, Japan, 260-8677
        • KalVista Investigative Site
      • Hiroshima, Japan, 730-8518
        • KalVista Investigative Site
      • Kawagoe-shi, Japan, 350-8550
        • KalVista Investigative Site
      • Maebashi, Japan, 371-8511
        • KalVista Investigative Site
      • Soka-shi, Japan, 340-0041
        • KalVista Investigative Site
      • Takatsuki-shi, Japan, 569-8686
        • KalVista Investigative Site
      • Tokyo, Japan, 142-8666
        • KalVista Investigative Site
      • Yokohama, Japan, 236-0004
        • KalVista Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 002-8072
        • KalVista Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • KalVista Investigative Site
  • New Zealand
      • Auckland, New Zealand, 1023
        • KalVista Investgative Site
  • Romania
      • Sângeorgiu de Mureş, Romania, 547530
        • KalVista Investigative Site
  • Slovakia
      • Martin, Slovakia, 036 59
        • KalVista Investigative Site
  • South Africa
      • Cape Town, South Africa, 7700
        • KalVista Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • KalVista Investigative Site
      • Barcelona, Spain, 08907
        • KalVista Investigative Site
      • Madrid, Spain, 28046
        • KalVista Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • KalVista Investigative Site
      • Cambridge, United Kingdom, CB2 0QQ
        • KalVista Investigative Site
      • Cardiff, United Kingdom, CF14 4XW
        • KalVista Investigative Site
      • Frimley, United Kingdom, GU16 7UJ
        • KalVista Investgative Site
      • Leeds, United Kingdom, LS9 7TF
        • KalVista Investigative Site
      • London, United Kingdom, E1 2ES
        • KalVista Investigative Site
      • London, United Kingdom, NW3 2QG
        • KalVista Investigative Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • KalVista Investigative Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • KalVista Investigative Site
    • California
      • San Diego, California, United States, 92122
        • KalVista Investigative Site
      • San Diego, California, United States, 92123
        • KalVista Investigative Site
      • Santa Monica, California, United States, 90404
        • KalVista Investigative Site
    • Colorado
      • Centennial, Colorado, United States, 80112
        • KalVista Investigative Site
      • Colorado Springs, Colorado, United States, 80907
        • KalVista Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47715
        • KalVista Investigative Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • KalVista Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • KalVista Investigative Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • KalVista Investigative Site
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • KalVista Investigative Site
    • Missouri
      • St Louis, Missouri, United States, 63141
        • KalVista Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • KalVista Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • KalVista Investigative Site
      • Toledo, Ohio, United States, 43617
        • KalVista Investigative Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • KalVista Investigative Site
    • Texas
      • Dallas, Texas, United States, 75231
        • KalVista Investigative Site
    • Utah
      • Layton, Utah, United States, 84041
        • KalVista Investigative Site
    • Washington
      • Spokane, Washington, United States, 99204
        • KalVista Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KVD900 600 mg
Drug: KVD900 600 mg
KVD900 Tablet 600 mg (2 x 300 mg)
Experimental: Experimental: KVD900 300 mg
Drug: Drug: KVD900 300 mg
KVD900 Tablet 300 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics - Cmax
Time Frame: Up to 6 hours after IMP administration
Up to 6 hours after IMP administration
Pharmacokinetics - Tmax
Time Frame: Up to 6 hours after IMP administration
Up to 6 hours after IMP administration
Pharmacokinetics - AUC
Time Frame: Up to 6 hours after IMP administration
Up to 6 hours after IMP administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KalVista Pharmaceuticals, Ltd.

Investigators

  • Study Director: Study Director, KalVista Pharmaceuticals, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2022

Primary Completion (Actual)

May 27, 2026

Study Completion (Actual)

May 27, 2026

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KVD900-302a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared until all global regulatory filings are complete.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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