A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

Completed · Phase 3 · Has a placebo group

Conditions studied: Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

In brief

The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

Key facts

Study ID

NCT01807949

Run by

Vertex Pharmaceuticals Incorporated

People needed

563

Starts

2013-04-01

Expected to finish

2014-04-01

Last updated by the study team

2016-09-27

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of CF
• Homozygous for the F508del CFTR mutation
• Forced expiratory volume in 1 second (FEV1) greater than or equal to (>=) 40 percent (%) and less than or equal to (=<) 90% of predicted normal for age, sex, and height
• Willing to remain on a stable CF medication regimen through Week 24 or, if applicable, the Safety Follow up Visit

You may not qualify if…

• An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before first dose of study drug
• History of solid organ or hematological transplantation
• History of alcohol or drug abuse in the past year
• Ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening.
• Use of strong inhibitors, moderate inducers, or strong inducers of Cytochrome P450 3A (CYP3A) within 14 days before Day 1 of dosing

Where it is running

• Study site — Sacramento, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — New Haven, Connecticut, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Portland, Maine, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Jackson, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Morristown, New Jersey, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Albany, New York, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Oakland, California, United States

Full record on ClinicalTrials.gov

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