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A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Participants With Cystic Fibrosis (CF)

NCT ID: NCT04969224

Last Updated: 2025-09-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-12

Study Completion Date

2022-07-26

Brief Summary

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This study will evaluate the effects of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) on cough and physical activity using wearable technology in CF participants.

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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 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in the treatment period approximately 13 weeks.

Group Type EXPERIMENTAL

ELX/TEZ/IVA

Intervention Type DRUG

Fixed dose combination (FDC) tablet for oral administration.

IVA

Intervention Type DRUG

Tablet for oral administration.

Interventions

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ELX/TEZ/IVA

Fixed dose combination (FDC) tablet for oral administration.

Intervention Type DRUG

IVA

Tablet 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

* Forced expiratory volume in 1 second (FEV1) value ≥30% and ≤90% predicted
* Heterozygous for CF transmembrane conductance regulator gene (CFTR) F508del mutation and a minimal function mutation (F/MF genotypes)

Exclusion Criteria

* Clinically significant liver cirrhosis
* Solid organ or hematological transplantation
* Non-ambulatory status
* Lung infection with organisms associated with a more rapid decline in pulmonary status
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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Royal Adelaide Hospital

Adelaide, , Australia

Site Status

The Prince Charles Hospital

Chermside, , Australia

Site Status

Alfred Hospital

Melbourne, VIC, , Australia

Site Status

Institute for Respiratory Health

Nedlands, , Australia

Site Status

Telethon Kids Institute

Nedlands, , Australia

Site Status

The Royal Children's Hospital

Parkville, VIC, , 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

University of Alberta Hospital, Edmonton Clinic

Edmonton, , Canada

Site Status

Queen Elizabeth II Health Sciences Center

Halifax, , Canada

Site Status

Hospital Universitari Vall d Hebron

Barcelona, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status

Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari

Sabadell, , Spain

Site Status

Countries

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Australia Belgium Canada 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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2021-001628-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VX20-445-126

Identifier Type: -

Identifier Source: org_study_id

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