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Само по покана Фаза 3 NCT05844449

Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older

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 vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis (CF).
Кой може да участва
Key Inclusion Criteria: Parts A and B: • Participants who have completed study drug treatment in the parent study (VX21-121-105; NCT Number: NCT05422222) Part B: -Meets at least 1 of the following criteria: * Completed study drug treatment in Part A * 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: * Hepatic cirrhosis with portal hypertension, moderate hepatic impairment, or severe hepatic impairment that might pose an additional risk in administering study drug * History of solid organ, hematological transplantation, or cancer * History of drug intolerance in the parent study Other protocol defined Inclusion/Exclusion criteria may apply.
Места на провеждане 9
Австралия (1)
The Kids Research Institute Australia
Nedlands
Канада (1)
Hospital for Sick Children - Pulmonology
Toronto
Франция (1)
Hopital Femme Mere-Enfant
Bron
Германия (1)
Charite Paediatric Pulmonology Department
Berlin
Нидерландия (1)
Sophia Children's Hospital
Rotterdam
New Zealand (1)
Starship Child Health
Grafton
Швеция (1)
Sahlgrenska Universitetssjukhuset - Göteborg CF-center
Gothenburg
Великобритания (1)
Noah's Ark Children's Hospital for Wales
Cardiff
САЩ (1)
Children's Hospital of Orange County
Orange , California
Технически детайли
Статус
Само по покана
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
1 Year
Здрави доброволци
Не
Начална дата
11.08.2023
Крайна дата
30.07.2029
Регистрационен номер
NCT05844449
Източник
anzctr
Запитване за медицински туризъм

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