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A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT04599465
Collaborator
(none)
69
Enrollment
41
Locations
1
Arm
17.8
Actual Duration (Months)
1.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF participants, 12 years of age and older who are heterozygous for the F508del mutation and a minimal function mutation (F/MF genotypes), with abnormal glucose metabolism.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects With Abnormal Glucose Metabolism
Actual Study Start Date :
Jan 18, 2021
Actual Primary Completion Date :
Jul 14, 2022
Actual Study Completion Date :
Jul 14, 2022

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 (FDC) 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. Change From Baseline in 2-hour Blood Glucose Levels Following an Oral Glucose Tolerance Test (OGTT) to the Average of Week 36 and Week 48 [Day 1 up to Week 48]

    Secondary Outcome Measures

    1. Proportion of Participants With Improvement in Dysglycemia Categorization at Week 48 [Day 1 up to Week 48]

    2. 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:

    • Heterozygous for F508del and an MF mutation (F/MF genotypes)

    • Forced expiratory volume in 1 second (FEV1) value ≥ 30% of predicted mean for age, sex, and height

    • Abnormal glucose tolerance determined by an OGTT as either:

    • Impaired glucose tolerance (IGT)

    • CF-related diabetes (CFRD)

    Key Exclusion Criteria:

    • Clinically significant liver cirrhosis with or without portal hypertension

    • Solid organ or hematological transplantation

    • Lung infection with organisms associated with a more rapid decline in pulmonary status

    • Type 1 or Type 2 diabetes

    • Duration of CFRD ≥5 years

    Other protocol defined Inclusion/Exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Adelaide Hospital Adelaide Australia
    2 The Prince Charles Hospital Chermside Australia
    3 Alfred Hospital Melbourne Australia
    4 Telethon Kids Institute Nedlands Australia
    5 The Royal Children's Hospital Parkville, VIC Australia
    6 Sydney Children's Hospital Randwick Australia
    7 Mater Adult Hospital South Brisbane Australia
    8 Queensland Children's Hospital South Brisbane Australia
    9 Westmead Hospital Westmead Australia
    10 Cliniques Universitaires de Bruxelles Hopital Erasme Brussels Belgium
    11 Universitair Ziekenhuis Gent Gent Belgium
    12 Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium
    13 Klinika Nemoci Plicnich a Tuberkulozy Brno Czechia
    14 Fakultni nemocnice v Motole Praha 5 Czechia
    15 Centre Hospitalier Intercommunal Creteil Créteil France
    16 CHRU de Lille - Hopital Albert Calmette Lille France
    17 CHU Marseille - Hopital Nord Marseille France
    18 Hopital Arnaud de Villeneuve Montpellier Cedex 5 France
    19 Centre Hospitalier Universitaire De Nantes - G. R. Laennec Nantes France
    20 Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur Nice France
    21 Centre Hospitalier Lyon Sud Pierre-Bénite France
    22 CHU de Rouen - Hopital Charles Nicolle Rouen Cedex, Seine Maritime France
    23 Hopitaux Universitaires de Strasbourg Strasbourg France
    24 Hopital Foch (Suresnes), Hopital Foch, Adultes Suresnes France
    25 Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona Ancona Italy
    26 IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico Genova Italy
    27 Azienda Ospedaliera Universitaria Policlinico G. Martino Messina Italy
    28 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano Italy
    29 Azienda Ospedaliero Universitaria Federico II Napoli Naples Italy
    30 Azienda Ospedaliera di Verona - Ospedale Civile Maggiore Verona Italy
    31 Academisch Medisch Centrum (Academic Medical Centre) Amsterdam Netherlands
    32 HagaZiekenhuis van den Haag Den Haag Netherlands
    33 University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis Heidelberglaan Netherlands
    34 Erasmus Medical Center Rotterdam Netherlands
    35 Hospital Saint Joan de Deu Barcelona Spain
    36 Hospital Universitari Vall d Hebron Barcelona Spain
    37 Hospital Universitari Vall d´Hebron Servicio de Broncoscopia Barcelona Spain
    38 Hospital Universitario 12 de Octubre Madrid Spain
    39 Hospital Universitario Ramon y Cajal Madrid Spain
    40 Hospital Virgen de la Arrixaca Murcia Spain
    41 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:
    NCT04599465
    Other Study ID Numbers:
    • VX19-445-117
    • 2020-003170-44
    First Posted:
    Oct 22, 2020
    Last Update Posted:
    Aug 5, 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 5, 2022