drugset / Trial / NCT04058210

VX-445/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF Genotypes)

NCT04058210

Expanded access Approved for marketing Vertex Pharmaceuticals Incorporated

Summary

The purpose of this program is to provide elexacaftor(ELX, VX-445)/tezacaftor(TEZ)/ivacaftor(IVA) combination therapy to CF patients in critical need who are 12 years of age and older, heterozygous for F508del and a minimal function (MF) mutation in response to unsolicited physician requests.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivacaftor Other / unclassified 150 mg Oral
Subject elexacaftor Small molecule Oral
Subject tezacaftor Other / unclassified Oral

Indications