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

NCT ID: NCT05111145

Last Updated: 2023-07-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-14

Study Completion Date

2022-12-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ELX/TEZ/IVA

Participants received ELX 200 mg once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in the treatment period for up to 36 weeks.

Group Type EXPERIMENTAL

ELX/TEZ/IVA

Intervention Type DRUG

Fixed-dose combination tablets for oral administration.

IVA

Intervention Type DRUG

Tablets for oral administration.

Interventions

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ELX/TEZ/IVA

Fixed-dose combination tablets for oral administration.

Intervention Type DRUG

IVA

Tablets for oral administration.

Intervention Type DRUG

Other Intervention Names

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VX-445/VX-661/VX-770 elexacaftor/tezacaftor/ivacaftor VX-770 ivacaftor

Eligibility Criteria

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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

Exclusion Criteria

* History of drug intolerance in a parent study
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Prince Charles Hospital

Chermside, , Australia

Site Status

Alfred Hospital

Melbourne, , Australia

Site Status

Institute for Respiratory Health

Nedlands, , Australia

Site Status

Telethon Kids Institute

Nedlands, , Australia

Site Status

The Royal Children's Hospital

Parkville, , Australia

Site Status

Mater Adult Hospital

South Brisbane, , Australia

Site Status

Queensland Children's Hospital

South Brisbane, , Australia

Site Status

Cliniques Universitaires de Bruxelles Hopital Erasme

Brussels, , Belgium

Site Status

Universitair Ziekenhuis Brussel - Campus Jette

Brussels, , Belgium

Site Status

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, , Belgium

Site Status

University of Calgary Medical Clinic of the Foothills Medical Centre

Calgary, , Canada

Site Status

Stollery Children's Hospital

Edmonton, , Canada

Site Status

Queen Elizabeth II Health Sciences Center

Halifax, , Canada

Site Status

Klinika Nemoci Plicnich a Tuberkulozy

Brno, , Czechia

Site Status

Fakultni nemocnice v Motole

Prague, , Czechia

Site Status

Hospital Saint Joan de Deu

Barcelona, , Spain

Site Status

Hospital Universitari Vall d Hebron

Barcelona, , Spain

Site Status

Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

Barcelona, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status

Hospital Virgen de la Arrixaca

Murcia, , Spain

Site Status

Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari

Sabadell, , Spain

Site Status

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status

Countries

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Australia Belgium Canada Czechia Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2020-004885-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VX20-445-121

Identifier Type: -

Identifier Source: org_study_id

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