A Phase 3, Randomized, Double-Blind,Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Save

Date Added
April 14th, 2015
PRO Number
Pro00043283
Researcher
Patrick Flume
Keywords
Adolescents, Cystic Fibrosis, Drug Studies, Lung, Pulmonary
Summary

This study will evaluate the safety of VX-661 in combination with ivacaftor over 3 months in subjects with Cystic Fibroisis 12-years-old and older who are heterozygous for the F508del mutation and a second CFTR Allele.This study has 2 treatment periods: an Ivacaftor Run-in Period for 4 weeks, followed by a treatment period for 8 weeks.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

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