Status:

COMPLETED

A Study Evaluating the Long-term Safety of VX-445 Combination Therapy

Lead Sponsor:

Vertex Pharmaceuticals Incorporated

Conditions:

Cystic Fibrosis

Eligibility:

All Genders

12+ years

Phase:

PHASE3

Brief Summary

This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).

Eligibility Criteria

Inclusion

  • Currently participating in study VX17-659-105 (NCT03447262)

Exclusion

  • History of drug intolerance in study VX17-659-105 that would pose an additional risk to the participant in the opinion of the investigator
  • Current participation in an investigational drug trial (other than study VX17-659-105)
  • Other protocol defined Inclusion/Exclusion criteria may apply.

Key Trial Info

Start Date :

August 9 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 14 2022

Estimated Enrollment :

458 Patients enrolled

Trial Details

Trial ID

NCT04043806

Start Date

August 9 2019

End Date

December 14 2022

Last Update

July 6 2023

Active Locations (97)

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Page 1 of 25 (97 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

2

Stanford University

Palo Alto, California, United States, 94304

3

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

4

Hartford Hospital

Hartford, Connecticut, United States, 06102