A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF)

Vertex Pharmaceuticals Incorporated86 enrolled

Overview

The purpose of this study is to evaluate the safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in participants with CF who are 12 years of age or older.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

ELX/TEZ/IVADRUG

Fixed-dose combination tablets for oral administration.

IVADRUG

Tablets for oral administration.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Completed study drug treatment in parent study (VX19-445-117 \[NCT04599465\] or VX20-445-126 \[NCT04969224\]), or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study Key Exclusion Criteria: * History of drug intolerance in a parent study Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (24)

The Prince Charles Hospital

Chermside, Australia

Outcomes

Primary Outcomes

Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame: Day 1 up to Week 36

Data from ClinicalTrials.gov

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