A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 Months of Age and Older

Vertex Pharmaceuticals Incorporated18 sites in 7 countries50 target enrollmentNovember 21, 2024

ConditionsCystic Fibrosis

InterventionsIVA ELX/TEZ/IVA

DrugsELX/TEZ/IVA IVA

Overview

Phase: Phase 3
Intervention: IVA
Conditions: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Enrollment: 50
Locations: 18
Primary Endpoint: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Status: Active, Not Recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).

Registry

clinicaltrials.gov

Start Date

November 21, 2024

End Date

September 30, 2027

Last Updated

6 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 VX22-445-122 Part B (NCT05882357) 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 drug intolerance in the parent study that would pose an additional risk to the participant
•Current participation in an investigational drug trial other than the parent study
•Other protocol defined Inclusion/Exclusion criteria may apply.