Clincosm LogoSign in Get a demo

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

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT04969224
Collaborator
(none)
82
Enrollment
19
Locations
1
Arm
9.4
Actual Duration (Months)
4.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
82 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 Effects of Elexacaftor/Tezacaftor/Ivacaftor on Cough and Physical Activity in Cystic Fibrosis Subjects 12 Years of Age and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Actual Study Start Date :
Oct 12, 2021
Actual Primary Completion Date :
Jul 26, 2022
Actual Study Completion Date :
Jul 26, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ELX/TEZ/IVA

Participants will receive ELX/TEZ/IVA fixed-dose combination (FDC) in the morning and IVA in the evening.

Drug: ELX/TEZ/IVA
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. Percent Reduction From Baseline in Cough Frequency (cough events per day) to the Average of Week 8 Through Week 12 [Baseline up to Week 12]

    Secondary Outcome Measures

    1. Absolute Change From Baseline in Total Step Count per day to the Average of Week 8 Through Week 12 [Baseline up to Week 12]

    Eligibility Criteria

    Criteria

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

    Key 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

    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, VIC Australia
    4 Institute for Respiratory Health Nedlands Australia
    5 Telethon Kids Institute Nedlands Australia
    6 The Royal Children's Hospital Parkville, VIC Australia
    7 Mater Adult Hospital South Brisbane Australia
    8 Queensland Children's Hospital South Brisbane Australia
    9 Cliniques Universitaires de Bruxelles Hopital Erasme Brussels Belgium
    10 Universitair Ziekenhuis Brussel - Campus Jette Brussels Belgium
    11 Universitair Ziekenhuis Gent Gent Belgium
    12 Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium
    13 University of Calgary Medical Clinic of the Foothills Medical Centre Calgary Canada
    14 University of Alberta Hospital, Edmonton Clinic Edmonton Canada
    15 Queen Elizabeth II Health Sciences Center Halifax Canada
    16 Hospital Universitari Vall d Hebron Barcelona Spain
    17 Hospital Universitario 12 de Octubre Madrid Spain
    18 Hospital Universitario Ramon y Cajal Madrid Spain
    19 Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari Sabadell 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:
    NCT04969224
    Other Study ID Numbers:
    • VX20-445-126
    • 2021-001628-16
    First Posted:
    Jul 20, 2021
    Last Update Posted:
    Aug 25, 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
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Fibrosis
    Ivacaftor
    Elexacaftor

    Study Results

    No Results Posted as of Aug 25, 2022