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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.
Study Design
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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
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Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Narkewicz, Michael -
Study Drugs:
N/A
Study Sites
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Closed to Enrollment
Colorado
Children's Hospital Colorado, Aurora, CO 80045
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Closed to Enrollment
Georgia
Emory University, Atlanta, GA 30327
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Closed to Enrollment
Illinois
Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL 60611
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Closed to Enrollment
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
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Closed to Enrollment
Maryland
Johns Hopkins University, Baltimore, MD 21287
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Closed to Enrollment
Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455
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Closed to Enrollment
Missouri
St. Louis Children's Hospital, St. Louis, MO 63110
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Closed to Enrollment
Ohio
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229
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Closed to Enrollment
Texas
Baylor College of Medicine, Houston, TX 77030
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Closed to Enrollment
Washington
Seattle Children's Hospital, Seattle, WA 98105
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 that was approved by the U.S. Food and Drug Administration on Oct. 21, 2019.
