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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
Recruiting
I'm InterestedTrial ID: NCT01807923
Purpose
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.
Official Title
A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Intervention(s):
drug: Ivacaftor
drug: Lumacaftor Plus Ivacaftor Combination
drug: Placebo
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Angela Leung
6507235193