The primary purpose of study is to evaluate the treatment effect of tezacaftor in combination with ivacaftor (TEZ/IVA) on chest imaging endpoints using low-dose computed tomography (LDCT) at Week 72, and to evaluate the safety of TEZ/IVA through Week 72.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
41
Unnamed facility
Chermside, Australia
Unnamed facility
Melbourne, Australia
Unnamed facility
Nedlands, Australia
Unnamed facility
New Lambton Heights, Australia
Absolute Change in Total Brody/CF-CT Score
The exploratory Brody/CF-CT score semi-quantitatively scores the degree of structural lung disease as shown on CT in participants with CF. The score ranges from a minimum of 0 to a maximum of 219 with higher scores indicating more severe structural lung disease.
Time frame: From Baseline at Week 72
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Week 76
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Placebo matched to IVA tablet.
Unnamed facility
Parkville SIC, Australia
Unnamed facility
Randwick, Australia
Unnamed facility
South Brisbane, Australia
Unnamed facility
Subiaco, Australia
Unnamed facility
Westmead, Australia