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A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation
Conditions
Interventions
LUM/IVA
Locations
23
United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Start Date
February 24, 2020
Primary Completion Date
August 22, 2023
Completion Date
August 22, 2023
Last Updated
September 19, 2024
NCT02417740
NCT06616857
NCT07108153
NCT02740868
NCT07274631
NCT07303621
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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