Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older

Last updated: March 22, 2024
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Completed

Phase

3

Condition

Cystic Fibrosis

Scar Tissue

Lung Disease

Treatment

IVA

ELX/TEZ/IVA

Clinical Study ID

NCT04183790
VX19-445-107
2019-001827-11
  • Ages > 6
  • All Genders

Study Summary

This study will evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Completed study drug treatment in parent study (VX18-445-106 Part B, NCT03691779), orhad study drug interruption(s) in parent study but completed study visits up to thelast scheduled visit of the Treatment Period in the parent study

Exclusion

Key Exclusion Criteria:

  • History of study drug intolerance in parent study Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: IVA
Phase: 3
Study Start date:
February 17, 2020
Estimated Completion Date:
February 24, 2024

Connect with a study center

  • Queensland Children's Hospital

    South Brisbane,
    Australia

    Site Not Available

  • The Children's Hospital at Westmead

    Westmead,
    Australia

    Site Not Available

  • The Hospital for Sick Children

    Toronto,
    Canada

    Site Not Available

  • British Columbia's Children's Hospital

    Vancouver,
    Canada

    Site Not Available

  • Children's Health Ireland at Crumlin

    Dublin,
    Ireland

    Site Not Available

  • Children's Health Ireland at Temple Street

    Dublin,
    Ireland

    Site Not Available

  • Birmingham Children's Hospital - NHS Foundation Trust

    Birmingham,
    United Kingdom

    Site Not Available

  • Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

    London,
    United Kingdom

    Site Not Available

  • Children's Hospital of Orange County

    Orange, California 92868
    United States

    Site Not Available

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Ann & Robert Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • The Children's Mercy Hospital

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Northwell Health- Long Island Jewish Medical Center

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Clinical Research of Charlotte

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

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