Current Environment:

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.

Intervention

Intervention Type

Intervention Name

DRUG

VX-659/TEZ/IVA

DRUG

IVA

Phase

PHASE3

Gender

ALL

Min Age

12 Years

Max Age

N/A

Download Date

2022-01-25

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

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