NCT05111145

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_3

Geographic Reach
5 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 14, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 11, 2023

Completed
Last Updated

July 11, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

October 27, 2021

Results QC Date

June 19, 2023

Last Update Submit

June 19, 2023

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

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

    Day 1 up to Week 36

Study Arms (1)

ELX/TEZ/IVA

EXPERIMENTAL

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.

Drug: ELX/TEZ/IVADrug: IVA

Interventions

ELX/TEZ/IVADRUG

Fixed-dose combination tablets for oral administration.

Also known as: VX-445/VX-661/VX-770, elexacaftor/tezacaftor/ivacaftor
ELX/TEZ/IVA
IVADRUG

Tablets for oral administration.

Also known as: VX-770, ivacaftor
ELX/TEZ/IVA

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of drug intolerance in a parent study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

The Prince Charles Hospital

Chermside, Australia

Location

Alfred Hospital

Melbourne, Australia

Location

Institute for Respiratory Health

Nedlands, Australia

Location

Telethon Kids Institute

Nedlands, Australia

Location

The Royal Children's Hospital

Parkville, Australia

Location

Mater Adult Hospital

South Brisbane, Australia

Location

Queensland Children's Hospital

South Brisbane, Australia

Location

Cliniques Universitaires de Bruxelles Hopital Erasme

Brussels, Belgium

Location

Universitair Ziekenhuis Brussel - Campus Jette

Brussels, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, Belgium

Location

University of Calgary Medical Clinic of the Foothills Medical Centre

Calgary, Canada

Location

Stollery Children's Hospital

Edmonton, Canada

Location

Queen Elizabeth II Health Sciences Center

Halifax, Canada

Location

Klinika Nemoci Plicnich a Tuberkulozy

Brno, Czechia

Location

Fakultni nemocnice v Motole

Prague, Czechia

Location

Hospital Saint Joan de Deu

Barcelona, Spain

Location

Hospital Universitari Vall d Hebron

Barcelona, Spain

Location

Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

Barcelona, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Spain

Location

Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari

Sabadell, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

elexacaftor, ivacaftor, tezacaftor drug combinationivacaftor

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Results Point of Contact

Title
Medical Monitor
Organization
Vertex Pharmaceuticals Incorporated
medicalinfo@vrtx.com
617-341-6777

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2021

First Posted

November 8, 2021

Study Start

January 14, 2022

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

July 11, 2023

Results First Posted

July 11, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Locations

ES(8)CA(3)AU(7)CZ(2)BE(4)