ACTIVE_NOT_RECRUITING

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

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Conditions

Hereditary AngioedemaKONFIDENT-SSebetralstat

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-24
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05511922

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.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Male or female adolescent patient 12 to 17 years of age at the time of enrollment and during sample collection in this PK subtrial.
  2. * Patient is currently participating in KVD900-302.
  3. * Patient must provide signed informed consent or assent (when applicable), and a legally authorized representative (LAR) must also provide signed informed consent when applicable.
  4. * 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.
  1. * Patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent.

Contacts and Locations

Principal Investigator

Study Director
STUDY_DIRECTOR
KalVista Pharmaceuticals, Ltd.

Study Locations (Sites)

KalVista Investigative Site
Scottsdale, Arizona, 85251
United States
KalVista Investigative Site
Little Rock, Arkansas, 72205
United States
KalVista Investigative Site
San Diego, California, 92122
United States
KalVista Investigative Site
San Diego, California, 92123
United States
KalVista Investigative Site
Santa Monica, California, 90404
United States
KalVista Investigative Site
Centennial, Colorado, 80112
United States
KalVista Investigative Site
Colorado Springs, Colorado, 80907
United States
KalVista Investigative Site
Evansville, Indiana, 47715
United States
KalVista Investigative Site
Overland Park, Kansas, 66211
United States
KalVista Investigative Site
Louisville, Kentucky, 40215
United States
KalVista Investigative Site
Chevy Chase, Maryland, 20815
United States
KalVista Investigative Site
Plymouth, Minnesota, 55446
United States
KalVista Investigative Site
Saint Louis, Missouri, 63141
United States
KalVista Investigative Site
Charlotte, North Carolina, 28277
United States
KalVista Investigative Site
Cincinnati, Ohio, 45236
United States
KalVista Investigative Site
Toledo, Ohio, 43617
United States
Kalvista Investigative Site
Hershey, Pennsylvania, 17033
United States
KalVista Investigative Site
Dallas, Texas, 75231
United States
KalVista Investigative Site
Layton, Utah, 84041
United States
KalVista Investigative Site
Spokane, Washington, 99204
United States

Collaborators and Investigators

Sponsor: KalVista Pharmaceuticals, Ltd.

  • 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 Registration Dates

Study Start Date2022-10-24
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2022-10-24
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • KONFIDENT-S
  • Sebetralstat

Additional Relevant MeSH Terms

  • Hereditary Angioedema