A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation

Completed · Phase 3 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation

Key facts

Study ID

NCT02514473

Run by

Vertex Pharmaceuticals Incorporated

People needed

206

Starts

2015-07-01

Expected to finish

2016-09-01

Last updated by the study team

2017-10-23

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who weigh ≥15 kg without shoes a the Screening Visit
• Subjects with confirmed diagnosis of CF at the Screening Visit.
• Subjects who are homozygous for the F508del CFTR mutation
• Subjects with ppFEV1 of ≥70 percentage points adjusted for age, sex, and height
• Subjects with a screening LCI2.5 result greater than or equal to 7.5

You may not qualify if…

• History of any comorbidity reviewed at the Screening Visit 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.
• Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject
• Clinically significant abnormalities in hemoglobin, liver function, or renal function at the Screening Visit.
• An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before Day 1
• History of solid organ or hematological transplantation at the Screening Visit

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Palo Alto, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Wilmington, Delaware, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Boston, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Manchester, New Hampshire, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Dayton, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Colchester, Vermont, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Norfolk, Virginia, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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