Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older

Vertex Pharmaceuticals Incorporated71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

ELX/TEZ/IVADRUG

Fixed-dose combination granules or tablets for oral administration.

IVADRUG

Granules or tablets for oral administration.

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

key 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 Key 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

Locations (22)

Banner University of Arizona Medical Center

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: From Day 1 up to Week 196

Secondary Outcomes

Absolute Change in Sweat Chloride (SwCl)

Time frame: From Baseline up to Week 192

Absolute Change in Lung Clearance Index (LCI) 2.5

Time frame: From Baseline up to Week 192

Data from ClinicalTrials.gov

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