drugset
drugset / Trial / NCT03447249

A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

NCT03447249 ↗

Phase 3 Completed 385 enrolled Vertex Pharmaceuticals Incorporated
RandomizedParallel-groupTriple-blindTreatment

Summary

This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).

Timeline

Start
2018-03-07
Primary completion
2019-02-05
Completion
2019-02-05

Drugs

EvaluationDrugModalityDoseRoute
Subject BAMOCAFTOR Small molecule 240 mg Oral
Subject Ivacaftor Other / unclassified 150 mg Oral
Subject tezacaftor Other / unclassified 100 mg Oral

Indications

cystic fibrosis