Overview
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor
Status:
Completed
Completed
Trial end date:
2017-01-20
2017-01-20
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Vertex Pharmaceuticals IncorporatedTreatments:
Ivacaftor
Criteria
Inclusion Criteria:- Homozygous for the F508del CFTR mutation, genotype to be confirmed at the Screening
Visit
- Confirmed diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative
pilocarpine iontophoresis
- Forced expiratory volume at one second (FEV1) ≥40% and ≤90% of predicted normal for
age, sex, and height during screening
- Stable CF disease as judged by the investigator
- Willing to remain on a stable CF medication regimen through Week 24 or, if applicable,
the Safety Follow up Visit
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
participant.
- 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 (females of childbearing potential must have a negative
pregnancy test at Screening and Day 1)
- Sexually active participants of reproductive potential who are not willing to follow
the contraception requirements