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

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05111145
Collaborator
(none)
86
Enrollment
24
Locations
1
Arm
20.5
Anticipated Duration (Months)
3.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis
Actual Study Start Date :
Jan 14, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ELX/TEZ/IVA

Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.

Drug: ELX/TEZ/IVA
Fixed-dose combination tablet for oral administration.
Other Names:
  • VX-445/VX-661/VX-770
  • elexacaftor/tezacaftor/ivacaftor

    • Drug: IVA
    Tablet for oral administration.
    Other Names:
  • VX-770
  • ivacaftor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Day 1 up to Week 52]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Prince Charles Hospital Chermside Australia
    2 Alfred Hospital Melbourne, VIC Australia
    3 Institute for Respiratory Health Nedlands Australia
    4 Telethon Kids Institute Nedlands Australia
    5 The Royal Children's Hospital Parkville, VIC Australia
    6 Mater Adult Hospital South Brisbane Australia
    7 Queensland Children's Hospital South Brisbane Australia
    8 Cliniques Universitaires de Bruxelles Hopital Erasme Brussels Belgium
    9 Universitair Ziekenhuis Brussel - Campus Jette Brussels Belgium
    10 Universitair Ziekenhuis Gent Gent Belgium
    11 Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium
    12 University of Calgary Medical Clinic of the Foothills Medical Centre Calgary Canada
    13 Stollery Children's Hospital Edmonton Canada
    14 Queen Elizabeth II Health Sciences Center Halifax Canada
    15 Klinika Nemoci Plicnich a Tuberkulozy Brno Czechia
    16 Fakultni nemocnice v Motole Praha 5 Czechia
    17 Hospital Saint Joan de Deu Barcelona Spain
    18 Hospital Universitari Vall d Hebron Barcelona Spain
    19 Hospital Universitari Vall d´Hebron Servicio de Broncoscopia Barcelona Spain
    20 Hospital Universitario 12 de Octubre Madrid Spain
    21 Hospital Universitario Ramon y Cajal Madrid Spain
    22 Hospital Virgen de la Arrixaca Murcia Spain
    23 Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari Sabadell Spain
    24 Hospital Universitario Virgen del Rocio Sevilla Spain

    Sponsors and Collaborators

    • Vertex Pharmaceuticals Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vertex Pharmaceuticals Incorporated
    ClinicalTrials.gov Identifier:
    NCT05111145
    Other Study ID Numbers:
    • VX20-445-121
    • 2020-004885-21
    First Posted:
    Nov 8, 2021
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Fibrosis
    Ivacaftor
    Elexacaftor

    Study Results

    No Results Posted as of Aug 24, 2022