A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
Phase 3 – large-scale trial before approval
Conditions:
Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
trial.available_in:
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Overview
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.
Who can participate
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.
Locations
19
Australia (1)
Royal Prince Alfred Hospital
Camperdown
Belgium (1)
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels
Canada (1)
University of Calgary Medical Clinic of the Foothills Medical Centre
Calgary
Czech Republic (1)
Klinika Detskych Infekcnich Nemoci
Brno
Denmark (1)
Aarhus University Hospital
Aarhus
France (1)
Groupe Hospitaler Pellegrin, CHU De Bordeaux
Bordeaux
Greece (1)
General Hospital of Thessaloniki "Papanikolaou"
Thessaloniki
Hungary (1)
National Koranyi Institute for TBC and Pulmonology
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