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