Search

Page Title

Clinical Trial Finder

Back to the Clinical Trial Finder

Observational Closed to Enrollment

Study to evaluate the effects of the triple-combination modulator, elexacaftor/tezacaftor/ivacaftor in children (PROMISE Pediatric Cohort) (PROMISE-OB-18 - Pediatric Cohort)

This observational study will measure the effects of the triple-combination therapy, elexacaftor/tezacaftor/ivacaftor, in children with CF. These drugs are intended to help CFTR protein function closer to normal. This study will look at how treatment with the triple-combination therapy affects children with CF across many different aspects of the disease. 

 This study is observational. The elexacaftor/tezacaftor/ivacaftor triple-combination therapy will not be prescribed as part of the study. Participants must receive a prescription for the triple-combination therapy from their own CF doctor. Participants will enroll in the study before they begin taking the triple-combination therapy. Researchers will then study changes in sweat chloride, lung function, and other aspects of the participant’s health to better understand how treatment with the triple-combination therapy affects different parts of the body. Researchers will also use samples collected during this study to help support future CF research.This study will require lung function tests (including multiple breath washout), sweat tests, blood draws, physical exams, and urine and stool samples. 

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    6 Years to 11 Years

  • 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

  • Closed to Enrollment

    Alabama

    University of Alabama at Birmingham, Birmingham, AL 35233

  • Closed to Enrollment

    California

    Stanford University Medical Center, Palo Alto, CA 94304

  • Closed to Enrollment

    Colorado

    Children's Hospital Colorado, Aurora, CO 80045

  • Closed to Enrollment

    Illinois

    Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL 60611

  • 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

    Maryland

    Johns Hopkins University, Baltimore, MD 21287

  • Closed to Enrollment

    Massachusetts

    Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115

  • Closed to Enrollment

    Minnesota

    The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455

  • Closed to Enrollment

    Missouri

    Washington University School of Medicine, St. Louis, MO 63110

  • Closed to Enrollment

    Missouri

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

  • Closed to Enrollment

    North Carolina

    University of North Carolina at Chapel Hill, Chapel Hill, NC 27599

  • Closed to Enrollment

    Ohio

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

  • Closed to Enrollment

    Ohio

    Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106

  • Closed to Enrollment

    Oregon

    Oregon Health & Science University, Portland, OR 97239

  • Closed to Enrollment

    Texas

    Baylor College of Medicine, Houston, TX 77030

  • Closed to Enrollment

    Virginia

    Virginia Commonwealth University, Richmond, VA 23219

  • Closed to Enrollment

    Washington

    Seattle Children's Hospital, Seattle, WA 98105

  • 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:

    6 Years to 11 Years

  • 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.

CONTACT THE CLINICAL TRIAL NAVIGATOR

Get personalized assistance and answers to your clinical trial questions.

Learn More

Sign up for clinical trial alerts

Get email updates about clinical trials that matter to you.

Check the Drug Development Pipeline

We’re attacking CF from every angle. Learn about the status of CF drugs in development.

Learn More