drugset
drugset / Trial / NCT02070744

Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion

NCT02070744 ↗

Phase 2 Completed 40 enrolled Vertex Pharmaceuticals Incorporated
RandomizedParallel-groupTriple-blindTreatment

Summary

The objective of this study was to evaluate the safety and efficacy of VX-661in combination with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del cystic fibrosis transmembrane conductance regulator (CFTR) mutation

Timeline

Start
2014-03
Primary completion
2016-05-27
Completion
2016-05-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivacaftor Other / unclassified 150 mg Oral
Subject tezacaftor Other / unclassified 50 mg Oral
Subject tezacaftor Other / unclassified 100 mg Oral

Indications

cystic fibrosis