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Clinical Trial Finder
Observational Closed to Enrollment
Study to evaluate the effects of the triple-combination modulator, elexacaftor/tezacaftor/ivacaftor (PROMISE) (PROMISE-OB-18)
PROMISE is a postapproval, real-world, observational study to understand the effects of elexacaftor/tezacaftor/ivacaftor (ETI) in clinical use in the United States.
This ongoing study is following people with CF who are at least 12 years of age who have been prescribed ETI triple-combination therapy clinically for up to 4 ½ years. This study evaluated participants before they began taking the triple-combination therapy as well as after taking the triple combination. The study evaluated lung function, sweat chloride, respiratory microbiology, inflammation, gastrointestinal symptoms and function, liver function, body composition/growth and CF-related diabetes. Blood and urine samples are being collected throughout the study to enable future research.Multiple manuscripts are expected to be written regarding the results of the numerous evaluations being conducted over the long duration of this study. The results included in this summary are the key results for the primary outcomes that were evaluated over the first 6 months of the study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
Two Copies F508del or One Copy F508del -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
This study is for people with CF who are eligible for the elexacaftor/tezacaftor/ivacaftor triple-combination therapy.
Study Design
-
Study Type: ?more info
Observational -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
4 years -
Number of Study Visits:
8
Additional Information
-
Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Rowe, Steven -
Study Drugs:
N/A
Study Sites
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Closed to Enrollment
Alabama
University of Alabama at Birmingham, Birmingham, AL 35233
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Closed to Enrollment
Alaska
Providence Alaska Medical Center, Anchorage, AK 99508
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Closed to Enrollment
Arkansas
University of Arkansas for Medical Sciences, Little Rock, AR 72205
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Closed to Enrollment
California
Stanford University Medical Center, Palo Alto, CA 94304
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Closed to Enrollment
Colorado
National Jewish Health, Denver, CO 80206
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Closed to Enrollment
Colorado
Children's Hospital Colorado, Aurora, CO 80045
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Closed to Enrollment
Connecticut
Yale University School of Medicine, New Haven, CT 06520
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Closed to Enrollment
District of Columbia
Children's National Medical Center, Washington, DC 20010
-
Closed to Enrollment
Florida
University of Florida, Gainesville, FL 32610
-
Closed to Enrollment
Georgia
Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30329
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Closed to Enrollment
Georgia
Augusta University, Augusta, GA 30912
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Closed to Enrollment
Georgia
Emory University, Atlanta, GA 30324
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Closed to Enrollment
Illinois
Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL 60611
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Closed to Enrollment
Illinois
OSF HealthCare Children’s Hospital of Illinois, Saint Francis Medical Center, Peoria, IL 61637
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Closed to Enrollment
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
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Closed to Enrollment
Iowa
University of Iowa, Iowa City, IA 52242
-
Closed to Enrollment
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
-
Closed to Enrollment
Kentucky
University of Kentucky, Lexington, KY 40506
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Closed to Enrollment
Maryland
Johns Hopkins University, Baltimore, MD 21287
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Closed to Enrollment
Massachusetts
Massachusetts General Hospital, Boston, MA 02114
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Closed to Enrollment
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115
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Closed to Enrollment
Michigan
University of Michigan Health System, Ann Arbor, MI 48109
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Closed to Enrollment
Michigan
Wayne State University Harper University Hospital, Detroit, MI 48201
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Closed to Enrollment
Michigan
Corewell Health Helen DeVos, Grand Rapids , MI 49503
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Closed to Enrollment
Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455
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Closed to Enrollment
Missouri
Washington University School of Medicine, St. Louis, MO 63110
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Closed to Enrollment
Missouri
Children's Mercy Kansas City, Kansas City, MO 64108
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Closed to Enrollment
Nebraska
University of Nebraska Medical Center, Omaha, NE 68198
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Closed to Enrollment
New Jersey
Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ 08901
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Closed to Enrollment
New York
The Cystic Fibrosis Center of Western New York, Buffalo, NY 14203
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Closed to Enrollment
New York
University of Rochester Medical Center Strong Memorial, Rochester, NY 14642
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Closed to Enrollment
New York
Beth Israel Medical Center, New York, NY 10003
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Closed to Enrollment
New York
Cohen Children's Medical Center of New York, New Hyde Park, NY 11042
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Closed to Enrollment
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
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Closed to Enrollment
New York
Children's Hospital of New York, New York, NY 10032
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Closed to Enrollment
New York
Lenox Hill Hospital Cystic Fibrosis Center, New York, NY 10028
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Closed to Enrollment
North Carolina
University of North Carolina at Chapel Hill, Chapel Hill, NC 27599
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Closed to Enrollment
Ohio
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229
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Closed to Enrollment
Ohio
Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195
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Closed to Enrollment
Ohio
Children's Hospital Medical Center of Akron, Akron, OH 44308
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Closed to Enrollment
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
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Closed to Enrollment
Oklahoma
Oklahoma Cystic Fibrosis Center, OKC, OK 73104
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Closed to Enrollment
Oregon
Oregon Health & Science University, Portland, OR 97239
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Closed to Enrollment
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, PA 19104
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Closed to Enrollment
Pennsylvania
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224
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Closed to Enrollment
Pennsylvania
Hershey Medical Center Pennsylvania State University, Hershey, PA 17033
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Closed to Enrollment
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
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Closed to Enrollment
Texas
Cook Children's Medical Center, Fort Worth, TX 76104
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Closed to Enrollment
Texas
University of Texas Southwestern, Dallas, TX 75390
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Closed to Enrollment
Texas
Baylor College of Medicine, Houston, TX 77030
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Closed to Enrollment
Utah
Adult Cystic Fibrosis Center at the University of Utah, Salt Lake City, UT 84112
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Closed to Enrollment
Virginia
University of Virginia, Charlottesville, VA 22903
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Closed to Enrollment
Virginia
Virginia Commonwealth University, Richmond, VA 23219
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Closed to Enrollment
Washington
Seattle Children's Hospital, Seattle, WA 98105
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Closed to Enrollment
Washington
University of Washington Medical Center, Seattle, WA 98195
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Closed to Enrollment
Wisconsin
Children's Wisconsin, Milwaukee, WI 53226
-
Closed to Enrollment
Wisconsin
University of Wisconsin, Madison, WI 53792
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
Two Copies F508del or One Copy F508del -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
This study is for people with CF who are eligible for the elexacaftor/tezacaftor/ivacaftor triple-combination therapy.

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