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Observational Closed to Enrollment

Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis (NARKEW07A0)

CF is characterized by an abnormality in the cystic fibrosis transmembrane conductance regulator (CFTR). In the, liver the role of CFTR is to promote bile flow. The mechanism by which the abnormality in CFTR leads to liver disease in CF is uncertain. The result of liver disease in CF is the development of biliary fibrosis leading to biliary cirrhosis that may progress to multilobular cirrhosis. There is a need to identify an early marker in patients with CF who are at increased risk for the development of cirrhosis. Timely recognition of these patients would allow for future studies of the pathophysiology of the development of cirrhosis and potentially lead to the development of new treatments. In addition early identification of this subgroup of CF patients allows for close monitoring and prompt assessment of candidates for new treatments if and when they become available.

 

Eligibility

  • Age:

    3 Years to 12 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

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

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:

    5

Additional Information

  • Phase: ?more info

    Not Applicable

  • Study Sponsor: ?more info

    Narkewicz, Michael

  • Study Drugs:

    N/A

Study Sites

  • Closed to Enrollment

    Colorado

    Children's Hospital Colorado, Aurora, CO 80045

  • Closed to Enrollment

    Georgia

    Emory University, Atlanta, GA 30322

  • 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

    Maryland

    Johns Hopkins University, Baltimore, MD 21287

  • Closed to Enrollment

    Minnesota

    The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455

  • Closed to Enrollment

    Missouri

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

  • Closed to Enrollment

    Ohio

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

  • Closed to Enrollment

    Texas

    Baylor College of Medicine, Houston, TX 77030

  • Closed to Enrollment

    Washington

    Seattle Children's Hospital, Seattle, WA 98105

Eligibility

  • Age:

    3 Years to 12 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

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

Clinical Studies 101

  • 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.

  • 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.

  • How Do Clinical Trials Work

    Each clinical trial has a study sponsor and a protocol. Potential drugs must move through four well-defined phases of testing in patients.

     

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