Evaluation of Fontan-Associated Liver Disease



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:12 - Any
Updated:2/14/2019
Start Date:February 20, 2018
End Date:December 31, 2020
Contact:David J Goldberg, MD
Email:goldbergda@email.chop.edu
Phone:2674268143

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Trial Summary
Trial Overview
Inclusion Criteria

Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study

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

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 magnetic resonance imaging elastography and evaluate MZ101 pharmacotherapy as
a potentially efficacious treatment to reduce liver stiffness.

Inclusion Criteria:

1. Enrollment in on-going Phase 3 Open-Label Safety Study

2. Informed assent from subject, informed consent from parent/legal guardian as
appropriate

Exclusion Criteria:

1. Non-enrollment in the on-going Phase 3 Open-Label Study

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
We found this trial at
17
sites
Children's Hospital Colorado
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Michael V DiMaria, MD
Phone: 720-777-4420
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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Cincinnati Children's Hospital Medical Center
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Bryan H Goldstein, MD
Phone: 513-636-7072
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Benjamin Frischhertz, MD
Phone: 615-322-2318
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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Children's Hospital of Philadelphia
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Stephen Paridon, MD
Phone: 215-590-3532
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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University of Michigan Congenital Heart Center
Ann Arbor, Michigan 48109
Principal Investigator: Kurt R Schumacher, MD
Phone: 734-232-8432
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Ann Arbor, MI
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Children's Healthcare of Atlanta
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Principal Investigator: Christopher Petit, MD
Phone: 404-785-1796
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, GA
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Boston Children's Hospital
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Jonathan Rhodes, MD
Phone: 617-355-3491
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Ryan Butts, MD
Phone: 843-792-9146
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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Texas Children's Hospital
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Daniel Penny, MD, PhD
Phone: 832-826-1997
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston, TX
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Children's Mercy Hospital
Kansas City, Kansas 66160
Principal Investigator: Jonathan B Wagner, DO
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Kansas City, KS
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Children's Mercy Hospital - Kansas City
Kansas City, Missouri 64108
Principal Investigator: Jonathan B Wagner, MD
Phone: 816-234-3000
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Kansas City, MO
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Children's Hospital of Wisconsin
9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: Salil Grinde, MD
Phone: 414-266-2380
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Milwaukee, WI
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University of Nebraska Children's Hospital and Medical Center
8200 Dodge St
Omaha, Nebraska 68114
Principal Investigator: Angela Yetman, MD
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Omaha, NE
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Primary Children's Medical Hospital/Dept. of Pediatric Cardiology
Salt Lake City, Utah 84113
Principal Investigator: Shaji C Menon, MD
Phone: 801-662-5400
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Salt Lake City, UT
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Hospital for Sick Children
555 University Avenue
Toronto, Ontario M5G 1X8
Principal Investigator: Seema Mital, MD
Phone: 4168137654
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Toronto,
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Childrens National Medical Center
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Anitha John, MD. PhD
Phone: 202-476-2728
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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Nemours Cardiac Center/Alfred I. duPont Hospital for Children
Wilmington, Delaware 19803
Principal Investigator: Amanda Shillingford, MD
Phone: 302-651-6600
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Wilmington, DE
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