Summary

for people ages 12 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This study will evaluate the efficacy of VX-445 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).

Official Title

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Keywords

Cystic Fibrosis Fibrosis VX-445 TEZ IVA

Eligibility

For people ages 12 years and up

Key Inclusion Criteria:

  • Heterozygous for the F508del mutation (F/MF).
  • Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height.

Key Exclusion Criteria:

  • Clinically significant cirrhosis with or without portal hypertension
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Lung infection with organisms associated with a more rapid decline in pulmonary status.
  • Solid organ or hematological transplantation.

Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94110 United States
  • Kaiser Permanente accepting new patients
    Oakland California 94611 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vertex Pharmaceuticals Incorporated
ID
NCT03525444
Phase
Phase 3
Study Type
Interventional
Last Updated