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Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young Children
Sponsor: Sonya Heltshe
Summary
This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact on children with cystic fibrosis (CF).
Official title: A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN Study)
Key Details
Gender
All
Age Range
Any - 10 Years
Study Type
OBSERVATIONAL
Enrollment
210
Start Date
2020-11-18
Completion Date
2029-12-01
Last Updated
2024-08-12
Healthy Volunteers
No
Conditions
Interventions
Ivacaftor or elexacaftor/tezacaftor/ivacaftor
In Part B, approved CFTR modulator as prescribed at the discretion of the treating physician -not dictated by the BEGIN investigators
Locations (35)
The Children's Hospital Alabama, University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University Medical Center
Palo Alto, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
The Nemours Children's Clinic - Orlando
Orlando, Florida, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, United States
Children's Mercy Kansas City
Kansas City, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
The Cystic Fibrosis Center of Western New York
Buffalo, New York, United States
Children's Hospital of New York
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
New York Medical College at Westchester Medical Center
Valhalla, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oklahoma Cystic Fibrosis Center
Oklahoma City, Oklahoma, United States
Oregon Health Sciences University
Portland, Oregon, United States
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern / Children's Health
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Primary Children's Cystic Fibrosis Center
Salt Lake City, Utah, United States
Vermont Children's Hospital
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States