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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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Disease Information

Descriptive Information
Brief Title † 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
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
Brief Summary The primary purpose of study is to evaluate the treatment effect of VX-661 in combination with ivacaftor (VX-661/ivacaftor) on chest imaging endpoints using low-dose computed tomography (LDCT) at Week 72, and to evaluate the safety of VX-661/ivacaftor through Week 72
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Change in CT imaging score from baseline at Week 72
Secondary Outcome Measure † Safety and tolerability assessments including number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Condition † Cystic Fibrosis
Intervention † DrugVX-661
Study Arms / Comparison Groups VX-661/ivacaftor Fixed-dose combination tablet of VX-661 100-mg/ivacaftor 150-mg and an evening dose of ivacaftor 150-mg to be taken approximately 12 hours after the morning dose Placebo visually-matched tablets to be taken on the same schedule as the active treatment.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 40
Start Date † September 2016
Completion Date October 2018
Primary Completion Date September 2018
Eligibility Criteria † Inclusion Criteria: - Homozygous for the F508del CFTR mutation - Confirmed diagnosis of CF - Percent predicted forced expiratory volume (ppFEV1) ≥70% of predicted normal for age, sex, and height during screening. - Stable CF disease as judged by the investigator Exclusion Criteria: - History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. - An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1 (first dose of study drug) - Pregnant or nursing females. - Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements. - Any contraindication to undergoing chest imaging, as per the site's institutional guidelines
Gender All
Ages 12 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Australia
Administrative Information
NCT ID † NCT02730208
Organization ID VX15-661-112
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Vertex Pharmaceuticals Incorporated
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date April 2017
First Received Date † March 31, 2016
Last Updated Date April 7, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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