drugset / Trial / NCT03061331

Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation

NCT03061331

Phase 2 Completed 20 enrolled Vertex Pharmaceuticals Incorporated
RandomizedCrossoverQuadruple-blindTreatment

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation.

Timeline

Start
2017-01-31
Primary completion
2017-09-06
Completion
2017-10-04

Drugs

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

Indications