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Активно (без набиране) Фаза 3 NCT05444257

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

Фаза 3 – широко изпитване преди одобрение
Заболявания: Cystic Fibrosis

Спонсор: Vertex Pharmaceuticals Incorporated

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
Кой може да участва
Key Inclusion Criteria: * Part A: Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period in the parent study * Part B: Completed study drug treatment in Part A; or had study drug interruption(s) in Part A, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of Part A Key Exclusion Criteria: * History of drug intolerance in a parent study * Pregnant or breast-feeding females at the time of enrollment in Part A Other protocol defined Inclusion/Exclusion criteria may apply.
Места на провеждане 19
Австралия (1)
Royal Prince Alfred Hospital
Camperdown
Белгия (1)
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels
Канада (1)
University of Calgary Medical Clinic of the Foothills Medical Centre
Calgary
Чехия (1)
Klinika Detskych Infekcnich Nemoci
Brno
Дания (1)
Aarhus University Hospital
Aarhus
Франция (1)
Groupe Hospitaler Pellegrin, CHU De Bordeaux
Bordeaux
Гърция (1)
General Hospital of Thessaloniki "Papanikolaou"
Thessaloniki
Унгария (1)
National Koranyi Institute for TBC and Pulmonology
Budapest
Ireland (1)
Cork University Hospital
Cork
Израел (1)
Hadassah Medical Organization
Jerusalem
Италия (1)
Azienda Ospedaliero Universitaria Ospedale Riuniti
Ancona
Нидерландия (1)
Academisch Medisch Centrum (Academic Medical Centre)
Amsterdam
New Zealand (1)
Canterbury District Health Board
Christchurch
Норвегия (1)
Haukeland Universitetssjukehus (CF)
Bergen
Полша (1)
Pediatric Hospital Polanki named of Maciej Płażyński
Gdansk
Испания (1)
Hospital Saint Joan de Deu
Barcelona
Швеция (1)
Sahlgrenska Universitetssjukhuset
Gothenburg
Великобритания (1)
Birmingham Heartlands Hospital
Birmingham
САЩ (1)
University of Alabama at Birmingham
Birmingham , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
12 Years
Здрави доброволци
Не
Начална дата
08.11.2022
Крайна дата
30.10.2026
Регистрационен номер
NCT05444257
Източник
anzctr
Запитване за медицински туризъм

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