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

PHASE3CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

February 20, 2018

Primary Completion Date

September 15, 2020

Study Completion Date

September 16, 2020

Conditions
Single Ventricle Heart Disease
Interventions
DRUG

Udenafil

Open-label extension with Udenafil 87.5 mg BID treatment for 52 weeks.

Trial Locations (17)

19104

Children's Hospital of Philadelphia, Philadelphia

19803

Nemours Cardiac Center/Alfred I. duPont Hospital for Children, Wilmington

20008

Children's National Medical Center, Washington D.C.

29425

Medical University of South Carolina, Charleston

30322

Children's Healthcare of Atlanta, Atlanta

37232

Vanderbilt University Medical Center, Nashville

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

53226

Children's Hospital of Wisconsin, Milwaukee

64108

Children's Mercy Hospital, Kansas City

Children's Mercy Hospital Kansas City, Kansas City

68114

University of Nebraska Children's Hospital and Medical Center, Omaha

77030

Texas Children's Hospital, Houston

80045

Children's Hospital Colorado, Aurora

84113

Primary Children's Medical Hospital/Dept. of Pediatric Cardiology, Salt Lake City

02115

Boston Children's Hospital, Boston

48109-4204

University of Michigan Congenital Heart Center, Ann Arbor

ON M5G 1X8

The Hospital for Sick Children, Toronto

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Mezzion Pharma Co. Ltd

INDUSTRY

NCT03430583 - Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness | Biotech Hunter | Biotech Hunter