Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study
Status: Unknown
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY
A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• Enrollment in on-going Phase 3 Open-Label Safety Study
• Informed assent from subject, informed consent from parent/legal guardian as appropriate
Locations
United States
Colorado
Children's Hospital Colorado
Aurora
Washington, D.c.
Children's National Medical Center
Washington
Delaware
Nemours Cardiac Center/Alfred I. duPont Hospital for Children
Wilmington
Georgia
Children's Healthcare of Atlanta
Atlanta
Kansas
Children's Mercy Hospital
Kansas City
Massachusetts
Boston Children's Hospital
Boston
Michigan
University of Michigan Congenital Heart Center
Ann Arbor
Missouri
Children's Mercy Hospital Kansas City
Kansas City
Nebraska
University of Nebraska Children's Hospital and Medical Center
Omaha
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
Texas Children's Hospital
Houston
Utah
Primary Children's Medical Hospital/Dept. of Pediatric Cardiology
Salt Lake City
Wisconsin
Children's Hospital of Wisconsin
Milwaukee
Other Locations
Canada
The Hospital for Sick Children
Toronto
Time Frame
Start Date: 2018-02-20
Completion Date: 2021-08-31
Participants
Target number of participants: 100
Treatments
MZ101
Dosing per treatment regimen
Authors
Sponsors
Leads: Mezzion Pharma Co. Ltd
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)