Overview

Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Status:
Completed

Trial end date:
2015-10-01

Target enrollment:

Participant gender:

Summary

This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Phase:

Phase 3

Details

Lead Sponsor:

Vertex Pharmaceuticals Incorporated

Treatments:

Ivacaftor