Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation

Summary

The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR) gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R, G970R, G1244E, S1251N, S1255P, or G1349D).

Timeline

Start

2012-07

Primary completion

2013-10

Completion

2013-10

Outcome

Met primary endpoint

registry Part 1: Ivacaftor vs Part 1: Placebo; p <0.0001; Least squares (LS) mean difference 10.6780 (95% CI 7.2559 to 14.1000) NCT01614470 ↗

Drugs

Indications