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 or heterozygous for the F508del mutation.

Conditions

  • Cystic Fibrosis

Recruitment Status

TERMINATED

Eligibility Criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Phase

PHASE3

Gender

ALL

Min Age

12 Years

Max Age

N/A

Download Date

2022-01-25

Principal Investigator

N/A

Intervention

Intervention Type

DRUG

DRUG

Intervention Name

VX-659/TEZ/IVA

IVA

Contact

For more information and to contact the study team:

A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy NCT03447262