Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del

Completed · Phase 3

Conditions studied: Cystic Fibrosis

In brief

This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F/F).

Key facts

Study ID

NCT03601637

Run by

Vertex Pharmaceuticals Incorporated

People needed

61

Starts

2018-09-07

Expected to finish

2021-10-29

Last updated by the study team

2023-01-06

Who can join

Age: 1 and older, up to 2. 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
• Stanford University — Palo Alto, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Yale New Haven Medical Center — New Haven, Connecticut, United States
• Nemours / Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Ann & Robert Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, 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
• University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
• Wake Forest University School of Medicine - Brenner Children's Hospital — Winston-Salem, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, 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

Full record on ClinicalTrials.gov

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