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

Last updated: January 6, 2025
Sponsor: KalVista Pharmaceuticals, Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Allergy

Hives (Urticaria)

Hereditary Angioedema

Treatment

KVD900 600 mg

Drug: KVD900 300 mg

Clinical Study ID

NCT05511922
KVD900-302a
  • Ages 12-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female adolescent patient 12 to 17 years of age at the time of enrollmentand 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 alegally authorized representative (LAR) must also provide signed informed consentwhen applicable.

  • Patient and LAR are willing and able to provide samples per the requirements of theprotocol, including willingness to complete forms and the electronic Diary, obtainand return samples in a timely manner, and obtain samples while within the requiredage limit.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 12
Treatment Group(s): 2
Primary Treatment: KVD900 600 mg
Phase: 3
Study Start date:
October 24, 2022
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • KalVista Investigative Site

    Campbelltown, 2560
    Australia

    Completed

  • KalVista Investigative Site

    Wien, 1090
    Austria

    Active - Recruiting

  • KalVista Investigative Site

    Sofia, 1431
    Bulgaria

    Active - Recruiting

  • KalVista Investigative Site

    Montréal, H2W 1R7
    Canada

    Active - Recruiting

  • KalVista Investigative Site

    Grenoble Cedex 9, 38043
    France

    Active - Recruiting

  • KalVista Investigative Site

    Lille, 59037
    France

    Active - Recruiting

  • KalVista Investigative Site

    Lille Cedex, 59037
    France

    Active - Recruiting

  • KalVista Investigative Site

    Paris, 75012
    France

    Completed

  • KalVista Investigative Site

    Berlin, 12203
    Germany

    Active - Recruiting

  • KalVista Investigative Site

    Frankfurt, 60590
    Germany

    Active - Recruiting

  • KalVista Investigative Site

    Mainz, 55131
    Germany

    Active - Recruiting

  • KalVista Investigative Site

    Morfelden-Walldorf, 64546
    Germany

    Active - Recruiting

  • KalVista Investigative Site

    Athens, 11521
    Greece

    Active - Recruiting

  • KalVista Investigative Site

    Haifa, 31048
    Israel

    Active - Recruiting

  • KalVista Investigative Site

    Petach Tikvah, 4920235
    Israel

    Active - Recruiting

  • KalVista Investigative Site

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • KalVista Investigative Site

    Tel Aviv, 64239
    Israel

    Active - Recruiting

  • KalVista Investigative Site

    Sapporo-city, Hokkaido 002-8072
    Japan

    Site Not Available

  • KalVista Investigative Site

    Chiba-shi, 260-8677
    Japan

    Site Not Available

  • KalVista Investigative Site

    Hiroshima-shi, 730-8518
    Japan

    Site Not Available

  • KalVista Investigative Site

    Kawagoe-shi, 350-8550
    Japan

    Site Not Available

  • KalVista Investigative Site

    Maebashi-city, 371-8511
    Japan

    Site Not Available

  • KalVista Investigative Site

    Soka-shi, 340-0041
    Japan

    Site Not Available

  • KalVista Investigative Site

    Takatsuki-shi, 569-8686
    Japan

    Site Not Available

  • KalVista Investigative Site

    Tokyo, 142-8666
    Japan

    Site Not Available

  • KalVista Investigative Site

    Yokohama-shi, 236-0004
    Japan

    Site Not Available

  • KalVista Investigative Site

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • KalVista Investgative Site

    Auckland, 1023
    New Zealand

    Active - Recruiting

  • KalVista Investigative Site

    Sângeorgiu De Mureş, 547530
    Romania

    Active - Recruiting

  • KalVista Investigative Site

    Martin, 036 59
    Slovakia

    Active - Recruiting

  • KalVista Investigative Site

    Cape Town, 7700
    South Africa

    Active - Recruiting

  • KalVista Investigative Site

    Barcelona, 08907
    Spain

    Completed

  • KalVista Investigative Site

    Madrid, 28046
    Spain

    Active - Recruiting

  • KalVista Investigative Site

    Birmingham, B9 5SS
    United Kingdom

    Active - Recruiting

  • KalVista Investigative Site

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • KalVista Investigative Site

    Cardiff, CF14 4XW
    United Kingdom

    Active - Recruiting

  • KalVista Investgative Site

    Frimley, GU16 7UJ
    United Kingdom

    Active - Recruiting

  • KalVista Investigative Site

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • KalVista Investigative Site

    London, E1 2ES
    United Kingdom

    Active - Recruiting

  • KalVista Investigative Site

    Scottsdale, Arizona 85251
    United States

    Active - Recruiting

  • KalVista Investigative Site

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • KalVista Investigative Site

    San Diego, California 92122
    United States

    Active - Recruiting

  • KalVista Investigative Site

    Santa Monica, California 90404
    United States

    Completed

  • KalVista Investigative Site

    Centennial, Colorado 80112
    United States

    Site Not Available

  • KalVista Investigative Site

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • KalVista Investigative Site

    Evansville, Indiana 47715
    United States

    Active - Recruiting

  • KalVista Investigative Site

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • KalVista Investigative Site

    Louisville, Kentucky 40215
    United States

    Completed

  • KalVista Investigative Site

    Chevy Chase, Maryland 20815
    United States

    Active - Recruiting

  • KalVista Investigative Site

    Plymouth, Minnesota 55446
    United States

    Active - Recruiting

  • KalVista Investigative Site

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • KalVista Investigative Site

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • KalVista Investigative Site

    Cincinnati, Ohio 45236
    United States

    Active - Recruiting

  • KalVista Investigative Site

    Toledo, Ohio 43617
    United States

    Active - Recruiting

  • Kalvista Investigative Site

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • KalVista Investigative Site

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • KalVista Investigative Site

    Layton, Utah 84041
    United States

    Active - Recruiting

  • KalVista Investigative Site

    Spokane, Washington 99204
    United States

    Active - Recruiting

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