A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older

Vertex Pharmaceuticals Incorporated22 sites in 5 countries71 target enrollmentJanuary 17, 2022

ConditionsCystic Fibrosis

InterventionsELX/TEZ/IVA IVA

DrugsELX/TEZ/IVA IVA

Overview

Phase: Phase 3
Intervention: ELX/TEZ/IVA
Conditions: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Enrollment: 71
Locations: 22
Primary Endpoint: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Status: Completed
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the long term safety, tolerability, efficacy and pharmacodynamics of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in CF participants 2 years of age and older.

Registry

clinicaltrials.gov

Start Date

January 17, 2022

End Date

January 29, 2026

Last Updated

2 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Vertex Pharmaceuticals Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Completed study drug treatment in the parent study (VX20-445-111 Part B, NCT04537793), or had study drug interruption(s) in the parent study, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of the parent study

Exclusion Criteria

•History of study drug intolerance in the parent study
•History of poor compliance with ELX/TEZ/IVA and/or procedures in the parent study
•Other protocol defined Inclusion/Exclusion criteria may apply