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NCT05111145 Clinical Trial

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

Cystic Fibrosis Clinical Trial

Official title:
A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05111145
Other study ID # VX20-445-121
Secondary ID 2020-004885-21
Status Completed
Phase Phase 3
First received
Last updated
Start date January 14, 2022
Est. completion date December 20, 2022

Study information
Verified date June 2023
Source Vertex Pharmaceuticals Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date December 20, 2022
Est. primary completion date December 20, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ELX/TEZ/IVA
Fixed-dose combination tablets for oral administration.
• IVA
Tablets for oral administration.

Locations
Country Name City State
Australia The Prince Charles Hospital Chermside
Australia Alfred Hospital Melbourne
Australia Institute for Respiratory Health Nedlands
Australia Telethon Kids Institute Nedlands
Australia The Royal Children's Hospital Parkville
Australia Mater Adult Hospital South Brisbane
Australia Queensland Children's Hospital South Brisbane
Belgium Cliniques Universitaires de Bruxelles Hopital Erasme Brussels
Belgium Universitair Ziekenhuis Brussel - Campus Jette Brussels
Belgium Universitair Ziekenhuis Gent Gent
Belgium Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven
Canada University of Calgary Medical Clinic of the Foothills Medical Centre Calgary
Canada Stollery Children's Hospital Edmonton
Canada Queen Elizabeth II Health Sciences Center Halifax
Czechia Klinika Nemoci Plicnich a Tuberkulozy Brno
Czechia Fakultni nemocnice v Motole Praha 5
Spain Hospital Saint Joan de Deu Barcelona
Spain Hospital Universitari Vall d Hebron Barcelona
Spain Hospital Universitari Vall d´Hebron Servicio de Broncoscopia Barcelona
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital Virgen de la Arrixaca Murcia
Spain Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari Sabadell
Spain Hospital Universitario Virgen del Rocio Sevilla

Sponsors (1)
Lead Sponsor Collaborator
Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  Czechia,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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