Actively Recruiting
Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young Children
Led by Sonya Heltshe · Updated on 2024-08-12
210
Participants Needed
35
Research Sites
471 weeks
Total Duration
On this page
Sponsors
S
Sonya Heltshe
Lead Sponsor
C
Cystic Fibrosis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Part A: Less than 10 years of age at the first study visit
- Part A: Documentation of a cystic fibrosis diagnosis
- Part B: Participated in Part A OR less than 7 years of age at the first study visit
- Part B: Documentation of a cystic fibrosis diagnosis
- Part B: CFTR mutations consistent with FDA labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor)
- Part B: Physician intent to prescribe ivacaftor or elexacaftor/tezacaftor/ivacaftor
You will not qualify if you...
- Use of an investigational drug within 28 days prior to and including the first study visit
- Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor within the 28 days prior to and including the first study visit
- Use of chronic oral corticosteroids within the 28 days prior to and including the first study visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
The Children's Hospital Alabama, University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Stanford University Medical Center
Palo Alto, California, United States, 94304
Actively Recruiting
3
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Actively Recruiting
5
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
6
The Nemours Children's Clinic - Orlando
Orlando, Florida, United States, 32827
Actively Recruiting
7
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
9
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
10
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
11
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
12
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
13
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
14
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
15
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108
Actively Recruiting
16
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
17
The Cystic Fibrosis Center of Western New York
Buffalo, New York, United States, 14203
Actively Recruiting
18
Children's Hospital of New York
New York, New York, United States, 10032
Actively Recruiting
19
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
20
New York Medical College at Westchester Medical Center
Valhalla, New York, United States, 10595
Actively Recruiting
21
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
22
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
23
Oklahoma Cystic Fibrosis Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
24
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
25
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
26
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
27
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
28
University of Texas Southwestern / Children's Health
Dallas, Texas, United States, 75207
Actively Recruiting
29
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
30
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
31
Primary Children's Cystic Fibrosis Center
Salt Lake City, Utah, United States, 84113
Actively Recruiting
32
Vermont Children's Hospital
Burlington, Vermont, United States, 05401
Actively Recruiting
33
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
34
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
35
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
R
Rachael Buckingham
CONTACT
A
Anna Mead
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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