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Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del

NCT05331183

Active Not RecruitingPhase 3

Sponsor: Vertex Pharmaceuticals Incorporated

Conditions: Cystic Fibrosis

Interventions: ELX/TEZ/IVA, IVA

Countries: Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Italy

This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation.

Eligibility overview

Sex: ALL

Age: 6 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

Part A: Completed study drug treatment in parent study or had study drug interruption(s) in parent study but 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 completed study visits up to the last scheduled visit of the treatment period of Part A

Key Exclusion Criteria:

History of study drug intolerance in the parent study

Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (81)

Innsbruck, Austria
Brussels, Belgium
Brussels, Belgium
Edegem, Belgium
Ghent, Belgium
Leuven, Belgium
Woluwe-Saint-Lambert, Belgium
Edmonton, Canada
Montreal, Canada
Montreal, Canada
Toronto, Canada
Vancouver, Canada
Vancouver, Canada
Brno, Czechia
Prague, Czechia
Bron, France
Créteil, France
Lille, France
Marseille, France
Montpellier, France
Nantes, France
Nice, France
Paris, France
Paris, France
Paris, France
Pierre-Bénite, France
Reims, France
Rennes, France
Roscoff, France
Toulouse, France
+ 51 more on CT.gov