Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease

Completed · Phase 3

Conditions studied: Cystic Fibrosis, Advanced Lung Disease

In brief

The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination therapy in subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del CFTR mutation

Key facts

Study ID

NCT02390219

Run by

Vertex Pharmaceuticals Incorporated

People needed

46

Starts

2015-03-01

Expected to finish

2016-10-01

Last updated by the study team

2017-12-06

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Homozygous for the F508del-CFTR mutation; historical genotype must be documented in the participant's source documents.
• Percent predicted FEV1 <40 of adjusted for age, sex, and height at Screening

You may not qualify if…

• Participant currently receiving invasive mechanical ventilation.
• 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
• Any clinically significant laboratory abnormalities at screening that would interfere with the study assessments or pose an undue risk for the subject
• A 12-lead electrocardiograms (ECG) demonstrating QTcF >450 msec at Screening
• 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 CYP3A
• Pregnant and nursing females: Females of childbearing potential must have a negative pregnancy test at Screening and Day 1.
• Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
• Use of beta blockers or the equivalent at Screening.

Where it is running

• Study site — Denver, Colorado, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — St Louis, Missouri, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.