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Observational Closed to Enrollment

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.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    Less than 5 Years

  • Mutation(s):

    See Other Primary Eligibility Criteria

  • FEV1% Predicted:

    62% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Part A of this study is for children with CF who are less than 5 years old and not on ivacaftor or the elexacaftor/tezacaftor/ivacaftor triple-combination therapy. Additionally, participants in Part A of this study cannot have mutations that are currently treatable with ivacaftor.

Study Design

  • Study Type: ?more info

    Observational

  • Randomized Study: ?more info

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    5 years

  • Number of Study Visits:

    8

Additional Information

  • Phase: ?more info

    Not Applicable

  • Study Sponsor: ?more info

    Ramsey, Bonnie

  • Study Drugs:

    N/A

Study Sites

  • Closed to Enrollment

    Alabama

    The Children's Hospital Alabama, University of Alabama at Birmingham, Birmingham, AL 35233

  • Closed to Enrollment

    Colorado

    Children's Hospital Colorado, Aurora, CO 80045

  • Closed to Enrollment

    Florida

    University of Miami, Miami, FL 33136

  • Closed to Enrollment

    Florida

    Nemours Children's Clinic - Jacksonville, Jacksonville, FL 32207

  • Closed to Enrollment

    Florida

    The Nemours Children's Clinic - Orlando, Orlando, FL 32827

  • Closed to Enrollment

    Indiana

    Riley Hospital for Children, Indianapolis, IN 46202

  • 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

    Massachusetts

    Boston Children's Hospital, Boston, MA 02115

  • Closed to Enrollment

    Michigan

    University of Michigan, Michigan Medicine, Ann Arbor, MI 48109

  • Closed to Enrollment

    Michigan

    Corewell Health Helen DeVos, Grand Rapids , MI 49503

  • Closed to Enrollment

    Minnesota

    The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55454

  • Closed to Enrollment

    Minnesota

    Children’s Hospitals and Clinics of Minnesota, Minneapolis, MN 55404

  • Closed to Enrollment

    Missouri

    Children's Mercy Kansas City, Kansas City, MO 64108

  • Closed to Enrollment

    Missouri

    St. Louis Children's Hospital, St. Louis, MO 63110

  • Closed to Enrollment

    New York

    The Cystic Fibrosis Center of Western New York, Buffalo, NY 14203

  • Closed to Enrollment

    New York

    New York Medical College at Westchester Medical Center, Valhalla, NY 10595

  • Closed to Enrollment

    New York

    Children's Hospital of New York, New York, NY 10032

  • Closed to Enrollment

    Ohio

    Nationwide Children's Hospital, Columbus, OH 43205

  • Closed to Enrollment

    Ohio

    Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229

  • Closed to Enrollment

    Oklahoma

    Oklahoma Cystic Fibrosis Center, OKC, OK 73104

  • Closed to Enrollment

    Oregon

    Oregon Health & Science University, Portland, OR 97239

  • Closed to Enrollment

    Pennsylvania

    Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224

  • Closed to Enrollment

    Pennsylvania

    Children's Hospital of Philadelphia, Philadelphia, PA 19104

  • Closed to Enrollment

    Pennsylvania

    Hershey Medical Center Pennsylvania State University, Hershey, PA 17033

  • Closed to Enrollment

    Texas

    University of Texas Southwestern / Children’s Health, Dallas, TX 75207

  • Closed to Enrollment

    Texas

    Cook Children's Medical Center, Fort Worth, TX 76104

  • Closed to Enrollment

    Texas

    Baylor College of Medicine, Houston, TX 77030

  • Closed to Enrollment

    Utah

    Primary Children's Cystic Fibrosis Center, Salt Lake City, UT 84113

  • Closed to Enrollment

    Vermont

    Vermont Children's Hospital, Burlington, VT 05401

  • Closed to Enrollment

    Virginia

    University of Virginia, Charlottesville, VA 22903

  • Closed to Enrollment

    Washington

    Seattle Children's Hospital, Seattle, WA 98115

  • Closed to Enrollment

    Wisconsin

    University of Wisconsin, Madison, WI 53792

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    Less than 5 Years

  • Mutation(s):

    See Other Primary Eligibility Criteria

  • FEV1% Predicted:

    62% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Part A of this study is for children with CF who are less than 5 years old and not on ivacaftor or the elexacaftor/tezacaftor/ivacaftor triple-combination therapy. Additionally, participants in Part A of this study cannot have mutations that are currently treatable with ivacaftor.

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