Page Title
Clinical Trial Finder
Observational Enrolling
Study to evaluate the effects of CFTR modulators in infants and young children (BEGIN Part B) (BEGIN-OB-19 Part B)
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.
In Part B of this study, researchers will observe the effects of CFTR modulators on growth in young children who start CFTR modulator therapy. They will measure weight and height over a 2-year period and collect information on GI symptoms and lung function. Children from Part A of this study may take part in Part B of this study if they become eligible for the CFTR modulator therapies included in the inclusion criteria and plan to start them.
This study will require physical exams, lung function tests, and/or other additional procedures.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
Less than 6 Years -
Mutation(s):
See Other Primary Eligibility Criteria -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants in Part B must either have participated in Part A of BEGIN or be less than 6 years old at the start of the study. Participants must have mutations that are eligible for highly effective CFTR modulators (either Kalydeco or Trikafta) and intend to start taking highly effective modulators (but not yet started them).
Study Design
-
Study Type: ?more info
Observational -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
2 years -
Number of Study Visits:
6
Additional Information
-
Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Ramsey, Bonnie -
Study Drugs:
N/A
Study Sites
-
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
-
Enrolling
California
Stanford University Medical Center, Palo Alto, CA 94304
Contact
Jacquelyn Spano
Phone: +1 (650) 721-1132
Email: jmzirbes@stanford.edu
-
Enrolling
Colorado
Children's Hospital Colorado, Aurora, CO 80045
Contact
Mary Cross
Phone: +1 (720) 777-4645
Email: mary.cross@childrenscolorado.org
-
Enrolling
Florida
University of Miami, Miami, FL 33136
Contact
Ylber (Ivan) Whitaker
Phone: +1 (305) 243-5545
Email: yiw2@miami.edu
-
Enrolling
Florida
The Nemours Children's Clinic - Orlando, Orlando, FL 32827
Contact
Sherry Wooldridge
Phone: +1 (407) 567-6206
Email: sherry.wooldridge@nemours.org
-
Enrolling
Florida
Nemours Children's Clinic - Jacksonville, Jacksonville, FL 32207
Contact
Jennifer (Jenn) Gafford
Phone: +1 (904) 697-3600
Email: Jennifer.gafford@nemours.org
-
Enrolling
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.edu
-
Enrolling
Iowa
University of Iowa, Iowa City, IA 52242
Contact
Mary Teresi
Phone: +1 (319) 384-7546
Email: mary-teresi@uiowa.edu
-
Enrolling
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
Contact
Lawrence Scott
Phone: +1 (913) 588-4020
Email: lscott2@kumc.edu
-
Enrolling
Massachusetts
Boston Children's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.edu
-
Enrolling
Michigan
University of Michigan, Michigan Medicine, Ann Arbor, MI 48109
Contact
Dawn Kruse
Phone: +1 (734) 615-3266
Email: dmkruse@med.umich.edu
-
Enrolling
Michigan
Corewell Health Helen DeVos, Grand Rapids , MI 49503
Contact
Andrew James
Phone: +1 (616) 267-0870
Email: andrew.james@corewellhealth.org
-
Enrolling
Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55454
Contact
Participant Contact University of Minnesota
Phone: +1
Email: cftrials@umn.edu
-
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
-
Enrolling
Missouri
St. Louis Children's Hospital, St. Louis, MO 63110
Contact
Irma Bauer
Phone: +1 (314) 747-2940
Email: irmabauer@wustl.edu
-
Enrolling
Missouri
Children's Mercy Kansas City, Kansas City, MO 64108
Contact
Jana Lomonte
Phone: +1 (816) 302-6308
Email: jblomonte@cmh.edu
-
Enrolling
New York
The Cystic Fibrosis Center of Western New York, Buffalo, NY 14203
Contact
Nadine Caci
Phone: +1 (716) 323-0110
Email: ncaci@upa.chob.edu
-
Enrolling
New York
SUNY Upstate Medical University, Syracuse, NY 13210
Contact
Mary Forell
Phone: +1 (315) 464-9209
Email: forellm@upstate.edu
-
Enrolling
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
Contact
Zachary Messer
Phone: +1 (914) 594-2352
Email: Zachary_Messer@nymc.edu
-
Enrolling
New York
Children's Hospital of New York, New York, NY 10032
Contact
Hossein Sadeghi
Phone: +1 (212) 305-5122
Email: HS762@cumc.Columbia.edu
-
Enrolling
Ohio
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229
Contact
Kelly Thornton
Phone: +1 (513) 636-0604
Email: Kelly.Thornton@cchmc.org
-
Enrolling
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.org
-
Enrolling
Oklahoma
Oklahoma Cystic Fibrosis Center, OKC, OK 73104
Contact
Participant Contact Oklahoma Cystic Fibrosis Center
Phone: +1 (405) 271-6216
Email: cfresearchteam@ouhsc.edu
-
Enrolling
Oregon
Oregon Health & Science University, Portland, OR 97239
Contact
Jenna Bucher
Phone: +1 (503) 494-7807
Email: bucherj@ohsu.edu
-
Enrolling
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, PA 19104
Contact
Erin Donnelly
Phone: +1 (609) 781-0307
Email: Donnellye4@email.chop.edu
-
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
-
Enrolling
Pennsylvania
Hershey Medical Center Pennsylvania State University, Hershey, PA 17033
Contact
Diane Kitch
Phone: +1 (717) 531-5646
Email: dkitch@pennstatehealth.psu.edu
-
Enrolling
Texas
University of Texas Southwestern / Children’s Health, Dallas, TX 75207
Contact
Keianna Brown
Phone: +1 (214) 456-5489
Email: Keianna.brown@utsouthwestern.edu
-
Enrolling
Texas
Cook Children's Medical Center, Fort Worth, TX 76104
Contact
Anna Reyes
Phone: +1 (682) 885-6589
Email: anna.reyes@cookchildrens.org
-
Enrolling
Texas
Baylor College of Medicine, Houston, TX 77030
Contact
Tracy Mosely
Phone: +1 (832) 822-3309
Email: tlmosely@texaschildrens.org
-
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
-
Enrolling
Vermont
Vermont Children's Hospital, Burlington, VT 05401
Contact
Julie Sweet
Phone: +1 (802) 847-7958
Email: julie.sweet@uvmhealth.org
-
Enrolling
Virginia
University of Virginia, Charlottesville, VA 22903
Contact
Erica Tharrington
Phone: +1 (434) 297-7773
Email: SFV6AB@hscmail.mcc.virginia.edu
-
Enrolling
Washington
Seattle Children's Hospital, Seattle, WA 98105
Contact
Sharon McNamara
Phone: +1 (206) 987-3921
Email: sharon.mcnamara@seattlechildrens.org
-
Enrolling
Wisconsin
University of Wisconsin, Madison, WI 53792
Contact
Melanie Nelson
Phone: +1 (608) 265-4617
Email: mnelson@pediatrics.wisc.edu
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
Less than 6 Years -
Mutation(s):
See Other Primary Eligibility Criteria -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants in Part B must either have participated in Part A of BEGIN or be less than 6 years old at the start of the study. Participants must have mutations that are eligible for highly effective CFTR modulators (either Kalydeco or Trikafta) and intend to start taking highly effective modulators (but not yet started them).
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