A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Phase 3 Completed 57 enrolled Vertex Pharmaceuticals Incorporated

NaSingle-groupOpen-labelTreatment

A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for F508del.

Evaluation	Drug	Modality	Dose	Route
Subject	Ivacaftor	Other / unclassified	125 mg	Oral
Subject	Ivacaftor	Other / unclassified	188 mg	Oral
Subject	Ivacaftor	Other / unclassified	250 mg	Oral
Subject	Lumacaftor	Small molecule	100 mg	Oral
Subject	Lumacaftor	Small molecule	150 mg	Oral
Subject	Lumacaftor	Small molecule	200 mg	Oral