Status:

TERMINATED

A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy

Lead Sponsor:

Vertex Pharmaceuticals Incorporated

Conditions:

Cystic Fibrosis

Eligibility:

All Genders

12+ years

Phase:

PHASE3

Brief Summary

This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous o...

Eligibility Criteria

Inclusion

  • Completed study drug treatment in a parent study; or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study.

Exclusion

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

Key Trial Info

Start Date :

July 13 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 9 2020

Estimated Enrollment :

484 Patients enrolled

Trial Details

Trial ID

NCT03447262

Start Date

July 13 2018

End Date

September 9 2020

Last Update

January 25 2022

Active Locations (100)

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Page 1 of 25 (100 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