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Active (not recruiting) Phase 3 NCT05511922

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

Phase 3 – large-scale trial before approval
Conditions: Hereditary Angioedema

Sponsor: KalVista Pharmaceuticals, Ltd.

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 16
Australia (1)
KalVista Investigative Site
Campbelltown
Bulgaria (1)
KalVista Investigative Site
Sofia
Canada (1)
KalVista Investigative Site
Montreal
France (1)
KalVista Investigative Site
Grenoble
Germany (1)
KalVista Investigative Site
Berlin
Greece (1)
KalVista Investigative Site
Athens
Israel (1)
KalVista Investigative Site
Haifa
Japan (1)
KalVista Investigative Site
Sapporo , Hokkaido
Netherlands (1)
KalVista Investigative Site
Amsterdam
New Zealand (1)
KalVista Investgative Site
Auckland
Romania (1)
KalVista Investigative Site
Sângeorgiu de Mureş
Slovakia (1)
KalVista Investigative Site
Martin
South Africa (1)
KalVista Investigative Site
Cape Town
Spain (1)
KalVista Investigative Site
Barcelona
United Kingdom (1)
KalVista Investigative Site
Birmingham
United States (1)
KalVista Investigative Site
Scottsdale , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
24.10.2022
Completion date
30.06.2026
Registry ID
NCT05511922
Source
anzctr
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