drugset
drugset / Trial / NCT02508207

A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

NCT02508207 ↗

Phase 2 Completed 34 enrolled Vertex Pharmaceuticals Incorporated
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661 (tezacaftor; TEZ) in combination with ivacaftor (IVA) (TEZ/IVA) in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

Timeline

Start
2016-02
Primary completion
2017-06
Completion
2017-06

Drugs

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

Indications

cystic fibrosis