Clinical trial NCT05511922: PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
Official title: A Pharmacokinetic Subtrial in Adolescent Patients With Hereditary Angioedema Type I or II Participating in the KVD900-302 Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hereditary Angioedema
Keywords: KONFIDENT-S
Sebetralstat
Lead sponsor: KalVista Pharmaceuticals, Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-23
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Pharmacokinetics - Cmax
timeFrame: Up to 6 hours after IMP administration
measure: Pharmacokinetics - Tmax
timeFrame: Up to 6 hours after IMP administration
measure: Pharmacokinetics - AUC
timeFrame: Up to 6 hours after IMP administration
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: KalVista Investigative Site
state: Arizona
city: Little Rock
country: United States
facility: KalVista Investigative Site
state: Arkansas
city: San Diego
country: United States
facility: KalVista Investigative Site
state: California
city: San Diego
country: United States
facility: KalVista Investigative Site
state: California
city: Santa Monica
country: United States
facility: KalVista Investigative Site
state: California
city: Centennial
country: United States
facility: KalVista Investigative Site
state: Colorado
city: Colorado Springs
country: United States
facility: KalVista Investigative Site
state: Colorado
city: Evansville
country: United States
facility: KalVista Investigative Site
state: Indiana
city: Overland Park
country: United States
facility: KalVista Investigative Site
state: Kansas
city: Louisville
country: United States
facility: KalVista Investigative Site
state: Kentucky
city: Chevy Chase
country: United States
facility: KalVista Investigative Site
state: Maryland
city: Plymouth
country: United States
facility: KalVista Investigative Site
state: Minnesota
city: Saint Louis
country: United States
facility: KalVista Investigative Site
state: Missouri
city: Charlotte
country: United States
facility: KalVista Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: KalVista Investigative Site
state: Ohio
city: Toledo
country: United States
facility: KalVista Investigative Site
state: Ohio
city: Hershey
country: United States
facility: Kalvista Investigative Site
state: Pennsylvania
city: Dallas
country: United States
facility: KalVista Investigative Site
state: Texas
city: Layton
country: United States
facility: KalVista Investigative Site
state: Utah
city: Spokane
country: United States
facility: KalVista Investigative Site
state: Washington
city: Campbelltown
country: Australia
facility: KalVista Investigative Site
city: Wien
country: Austria
facility: KalVista Investigative Site
city: Sofia
country: Bulgaria
facility: KalVista Investigative Site
city: Montréal
country: Canada
facility: KalVista Investigative Site
city: Grenoble Cedex 9
country: France
facility: KalVista Investigative Site
city: Lille Cedex
country: France
facility: KalVista Investigative Site
city: Lille
country: France
facility: KalVista Investigative Site
city: Paris
country: France
facility: KalVista Investigative Site
city: Berlin
country: Germany
facility: KalVista Investigative Site
city: Frankfurt
country: Germany
facility: KalVista Investigative Site
city: Mainz
country: Germany
facility: KalVista Investigative Site
city: Morfelden-Walldorf
country: Germany
facility: KalVista Investigative Site
city: Athens
country: Greece
facility: KalVista Investigative Site
city: Athens
country: Greece
facility: KalVista Investigative Site
city: Haifa
country: Israel
facility: KalVista Investigative Site
city: Petach Tikvah
country: Israel
facility: KalVista Investigative Site
city: Ramat Gan
country: Israel
facility: KalVista Investigative Site
city: Tel Aviv
country: Israel
facility: KalVista Investigative Site
city: Sapporo-city
country: Japan
facility: KalVista Investigative Site
state: Hokkaido
city: Chiba-shi
country: Japan
facility: KalVista Investigative Site
city: Hiroshima-shi
country: Japan
facility: KalVista Investigative Site
city: Kawagoe-shi
country: Japan
facility: KalVista Investigative Site
city: Maebashi-city
country: Japan
facility: KalVista Investigative Site
city: Soka-shi
country: Japan
facility: KalVista Investigative Site
city: Takatsuki-shi
country: Japan
facility: KalVista Investigative Site
city: Tokyo
country: Japan
facility: KalVista Investigative Site
city: Yokohama-shi
country: Japan
facility: KalVista Investigative Site
city: Amsterdam
country: Netherlands
facility: KalVista Investigative Site
city: Auckland
country: New Zealand
facility: KalVista Investgative Site
city: Sângeorgiu De Mureş
country: Romania
facility: KalVista Investigative Site
city: Martin
country: Slovakia
facility: KalVista Investigative Site
city: Cape Town
country: South Africa
facility: KalVista Investigative Site
city: Barcelona
country: Spain
facility: KalVista Investigative Site
city: Barcelona
country: Spain
facility: KalVista Investigative Site
city: Madrid
country: Spain
facility: KalVista Investigative Site
city: Birmingham
country: United Kingdom
facility: KalVista Investigative Site
city: Cambridge
country: United Kingdom
facility: KalVista Investigative Site
city: Cardiff
country: United Kingdom
facility: KalVista Investigative Site
city: Frimley
country: United Kingdom
facility: KalVista Investgative Site
city: Leeds
country: United Kingdom
facility: KalVista Investigative Site
city: London
country: United Kingdom
facility: KalVista Investigative Site
city: London
country: United Kingdom
facility: KalVista Investigative Site
Study officials:
affiliation: KalVista Pharmaceuticals, Ltd.
name: Study Director
role: STUDY_DIRECTOR
References: