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Observational Enrolling
Study to evaluate the effects of CFTR modulators in infants and young children (BEGIN Part A) (BEGIN-OB-19 Part A)
This two-part observational study will look at the effects of CFTR modulators on growth in young children with CF. These drugs are intended to help CFTR protein function closer to normal.
Part A of this study will enroll young children with CF who are not yet taking CFTR modulators. Researchers will collect information on growth factors in these young children by measuring weight and height for up to 3 years. Researchers will also collect information on gastrointestinal (GI) symptoms and lung function. Children who enroll in Part A of this study may also choose to enroll in Part B of this study once they begin taking CFTR modulator treatment with elexacaftor/tezacaftor/ivacaftor to observe how that drug impacts their growth and health.
This study will require physical exams, lung function tests, and/or other additional procedures.
Study Design
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Study Type: ?more info
Observational -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
3 years -
Number of Study Visits:
6
Additional Information
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Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Ramsey, Bonnie -
Study Drugs:
N/A
Study Sites
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Enrolling
Alabama
The Children's Hospital Alabama, University of Alabama at Birmingham, Birmingham, AL 35233
Contact
Heather Hathorne
Phone: +1 (205) 638-9568
Email: hyhathorne@uabmc.edu
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Enrolling
Colorado
Children's Hospital Colorado, Aurora, CO 80045
Contact
Mary Cross
Phone: +1 (720) 777-4645
Email: mary.cross@childrenscolorado.org
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Enrolling
Florida
University of Miami, Miami, FL 33136
Contact
Alejandra Weisman
Phone: +1 (305) 243-1425
Email: a.weisman1@miami.edu
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Enrolling
Florida
The Nemours Children's Clinic - Orlando, Orlando, FL 32827
Contact
Kristen Gibbs
Phone: +1
Email: Kristen.Gibbs@nemours.org
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Closed to Enrollment
Florida
Nemours Children's Clinic, Jacksonville, FL 32207
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Enrolling
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.edu
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Enrolling
Iowa
University of Iowa, Iowa City, IA 52242
Contact
Mary Teresi
Phone: +1 (319) 384-7546
Email: mary-teresi@uiowa.edu
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Enrolling
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
Contact
Lawrence Scott
Phone: +1 (913) 588-4020
Email: lscott2@kumc.edu
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Enrolling
Massachusetts
Boston Children's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.edu
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Closed to Enrollment
Michigan
University of Michigan, Michigan Medicine, Ann Arbor, MI 48109
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Enrolling
Michigan
Helen DeVos Children's Hospital, Grand Rapids , MI 49503
Contact
Heather Mulroy
Phone: +1 (616) 391-0384
Email: heather.mulroy@spectrumhealth.org
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Enrolling
Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455
Contact
Participant Contact University of Minnesota
Phone: +1
Email: cftrials@umn.edu
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Enrolling
Minnesota
Children’s Hospitals and Clinics of Minnesota, Minneapolis, MN 55404
Contact
Elizabeth Franck Thompson
Phone: +1 (612) 813-6347
Email: elizabeth.franckthompson@childrensmn.org
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Enrolling
Missouri
St. Louis Children's Hospital, St. Louis, MO 63110
Contact
Tina Hicks
Phone: +1 (314) 747-2707
Email: hickst@wustl.edu
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Enrolling
Missouri
Children's Mercy Kansas City, KCMO, MO 64108
Contact
Candy Schmoll
Phone: +1 (816) 302-3538
Email: cschmoll@cmh.edu
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Closed to Enrollment
New York
The Cystic Fibrosis Center of Western New York, Buffalo, NY 14203
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Enrolling
New York
SUNY Upstate Medical University, Syracuse, NY 13210
Contact
Mary Forell
Phone: +1 (315) 464-9209
Email: forellm@upstate.edu
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Closed to Enrollment
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
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Enrolling
New York
Children's Hospital of New York, New York, NY 10032
Contact
Carmen Liriano
Phone: +1 (212) 305-6265
Email: crl58@cumc.columbia.edu
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Enrolling
Ohio
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229
Contact
Kelly Thornton
Phone: +1 (513) 636-0604
Email: Kelly.Thornton@cchmc.org
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Enrolling
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.org
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Closed to Enrollment
Oklahoma
Oklahoma Cystic Fibrosis Center, OKC, OK 73104
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Enrolling
Oregon
Oregon Health Sciences University, Portland, OR 97239
Contact
Brendan Klein
Phone: +1 (503) 418-8108
Email: kleinb@ohsu.edu
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Enrolling
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, PA 19104
Contact
Erin Donnelly
Phone: +1 (267) 426-9626
Email: Donnellye4@email.chop.edu
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Enrolling
Pennsylvania
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224
Contact
Elizabeth Hartigan
Phone: +1 (412) 692-7060
Email: elizabeth.hartigan@chp.edu
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Closed to Enrollment
Pennsylvania
Hershey Medical Center Pennsylvania State University, Hershey, PA 17033
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Enrolling
Texas
University of Texas Southwestern / Children’s Health, Dallas, TX 75207
Contact
Casey Power
Phone: +1
Email: casey.power@utsouthwestern.edu
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Closed to Enrollment
Texas
Cook Children's Medical Center, Fort Worth, TX 76104
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Enrolling Soon
Texas
Baylor College of Medicine, Houston, TX 77030
Contact
Katie Howe
Phone: +1 (832) 822-4252
Email: klhowe@texaschildrens.org
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Enrolling
Utah
Primary Children's Cystic Fibrosis Center, Salt Lake City, UT 84113
Contact
Jane Vroom
Phone: +1 (801) 587-7458
Email: jane.vroom@hsc.utah.edu
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Closed to Enrollment
Vermont
Vermont Children's Hospital, Burlington, VT 05401
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Closed to Enrollment
Virginia
University of Virginia, Charlottesville, VA 22903
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Enrolling
Washington
Seattle Children's Hospital, Seattle, WA 98105
Contact
Sharon McNamara
Phone: +1 (206) 987-3921
Email: sharon.mcnamara@seattlechildrens.org
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Closed to Enrollment
Wisconsin
University of Wisconsin, Madison, WI 53792
Related Topics
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Questions to Ask When Considering a Specific Trial
Clinical trials that test potential drugs and therapies in people with cystic fibrosis are a major part of CF research. They take place at Cystic Fibrosis Foundation-accredited care centers all over the United States and enroll people with CF of all ages.
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Patient Safety Is a Priority
Nothing is more important than patient safety in developing new treatments for cystic fibrosis. The U.S. government requires that all clinical trials are supervised for safety, and the Cystic Fibrosis Foundation adds additional measures to protect study volunteers.
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Trikafta®
The following is a collection of information and news about Trikafta®, the triple-combination modulator therapy.
