drugset / Trial / NCT02709109

A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation

NCT02709109

RandomizedCrossoverTriple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of treatment with VX-371 in hypertonic saline compared to hypertonic saline alone in subjects with cystic fibrosis (CF) who are ≥12 years of age, homozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mutation, and being treated with Orkambi

Timeline

Start
2016-02
Primary completion
2017-09
Completion
2017-09

Drugs

EvaluationDrugModalityDoseRoute
Subject IDREVLORIDE Small molecule 85 ug Inhaled
Background Hypertonic saline Unknown 3 ml Inhaled
Background Ivacaftor Other / unclassified 2 unknown Oral

Indications