Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness

Completed · Phase 3

Conditions studied: Single Ventricle Heart Disease

In brief

A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.

Key facts

Study ID

NCT03430583

Run by

Mezzion Pharma Co. Ltd

People needed

88

Starts

2018-02-20

Expected to finish

2020-09-16

Last updated by the study team

2025-10-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrollment in on-going Phase 3 Open-Label Safety Study
• Informed assent from subject, informed consent from parent/legal guardian as appropriate

You may not qualify if…

• Non-enrollment in the on-going Phase 3 Open-Label Study
• Subjects with contra-indications for MRI (these subjects will be excluded from the MRI component of this study)
• Other exclusionary criteria will match those used for the Open-Label Safety Study

Where it is running

• 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

Full record on ClinicalTrials.gov

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