A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
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|ClinicalTrials.gov Identifier: NCT02730208|
Recruitment Status : Completed
First Posted : April 6, 2016
Results First Posted : August 21, 2019
Last Update Posted : October 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: Tezacaftor/Ivacaftor Drug: Ivacaftor Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase 2, Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||July 2018|
Participants received TEZ 100 milligram (mg)/IVA 150 mg fixed dose combination tablet orally once daily in the morning and IVA 150 mg tablet orally once daily in the evening for 72 weeks.
TEZ 100 mg/IVA 150 mg fixed-dose combination tablet.
Other Name: TEZ/IVA; VX-661/VX-770
IVA 150 mg tablet.
Other Name: VX-770; IVA
Placebo Comparator: Placebo
Participants received placebo matched to TEZ/IVA fixed dose combination tablet orally once daily in the morning and placebo matched to IVA tablet orally once daily in the evening for 72 weeks.
Placebo matched to TEZ/IVA fixed-dose combination tablet.
Placebo matched to IVA tablet.
- Absolute Change in Total Brody/CF-CT Score [ Time Frame: From Baseline at Week 72 ]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.
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to Week 76 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730208
|New Lambton Heights, Australia|
|Parkville SIC, Australia|
|South Brisbane, Australia|