Status:
COMPLETED
Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness
Lead Sponsor:
Mezzion Pharma Co. Ltd
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Single Ventricle Heart Disease
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.
Detailed Description
This is open-label, long-term prospective study in a cohort of Fontan subjects taking drug daily for one year. The study will determine the scope of hepatic stiffness in the cohort by ultrasound and m...
Eligibility Criteria
Inclusion
- Enrollment in on-going Phase 3 Open-Label Safety Study
- Informed assent from subject, informed consent from parent/legal guardian as appropriate
Exclusion
- 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
Key Trial Info
Start Date :
February 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2020
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03430583
Start Date
February 20 2018
End Date
September 16 2020
Last Update
October 14 2025
Active Locations (17)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Nemours Cardiac Center/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20008
4
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322