Overview

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

Status:
Completed
Trial end date:
2018-07-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Treatments:
Ivacaftor
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