Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation

Completed · Phase 3

Conditions studied: Cystic Fibrosis

In brief

This is a Phase 3, multicenter, open-label and roll-over study in participants who are 12 to \<24 months of age at initiation of Lumacaftor/Ivacaftor (LUM/IVA) treatment.

Key facts

Study ID

NCT04235140

Run by

Vertex Pharmaceuticals Incorporated

People needed

52

Starts

2020-02-24

Expected to finish

2023-08-22

Last updated by the study team

2024-09-19

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• 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
• Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• Cardinal Glennon Children's Hospital - St. Louis University — St Louis, Missouri, United States
• University of Rochester Medical Center — Rochester, New York, United States
• NC TraCS Institute - CTRC University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• University of Utah / Primary Children's Medical Center — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• McGill University Health Centre, Glen Site, Montreal Children's Hospital — Montreal, Canada
• The Hospital for Sick Children — Toronto, Canada
• British Columbia's Children's Hospital — Vancouver, Canada

Full record on ClinicalTrials.gov

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