drugset / Trial / NCT02823470

A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation

NCT02823470

Phase 4 Terminated 24 enrolled Vertex Pharmaceuticals Incorporated
RandomizedParallel-groupOpen-labelTreatment

Summary

The study will evaluate the impact of smart adherence technology for monitoring on lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with Cystic Fibrosis (CF) who are homozygous for the F508del Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) mutation.

Timeline

Start
2016-06
Primary completion
2017-08
Completion
2017-08

Drugs

EvaluationDrugModalityDoseRoute
Background Ivacaftor Other / unclassified 250 mg
Background Lumacaftor Small molecule 400 mg

Indications