Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness
NCT ID: NCT03430583
Last Updated: 2025-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
88 participants
INTERVENTIONAL
2018-02-20
2020-09-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Udenafil Continuation (U+)
Subjects who were receiving Udenafil 87.5 mg BID in FUEL study prior to enrolling to this study (FALD).
Udenafil
Open-label extension with Udenafil 87.5 mg BID treatment for 52 weeks.
Udenafil Naive (U-)
Subjects who were receiving Placebo BID in FUEL study prior to enrolling to this study (FALD).
Udenafil
Open-label extension with Udenafil 87.5 mg BID treatment for 52 weeks.
Interventions
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Udenafil
Open-label extension with Udenafil 87.5 mg BID treatment for 52 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Informed assent from subject, informed consent from parent/legal guardian as appropriate
Exclusion Criteria
2. Subjects with contra-indications for MRI (these subjects will be excluded from the MRI component of this study)
3. Other exclusionary criteria will match those used for the Open-Label Safety Study
12 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Mezzion Pharma Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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David J Goldberg, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Kurt R Schumacher, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Congenital Heart Center/C.S. Mott Children's Hospital
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Nemours Cardiac Center/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Children's Mercy Hospital
Kansas City, Kansas, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan Congenital Heart Center
Ann Arbor, Michigan, United States
Children's Mercy Hospital Kansas City
Kansas City, Missouri, United States
University of Nebraska Children's Hospital and Medical Center
Omaha, Nebraska, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Medical Hospital/Dept. of Pediatric Cardiology
Salt Lake City, Utah, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PHN-Udenafil-04
Identifier Type: -
Identifier Source: org_study_id
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