The FUEL-2 Study
Research type
Research Study
Full title
A 26-week, prospective, multicenter, randomized, double-blind, placebo-controlled safety and efficacy study of udenafil 87.5 mg tablets versus placebo in adolescent subjects who have had the Fontan procedure
IRAS ID
1013452
Contact name
Scott Oglesby
Contact email
Sponsor organisation
Mezzion Pharma Co Ltd.
Eudract number
2023-507255-30
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to find out if the investigational study drug, udenafil, is effective and safe in adolescent participants between 12 and 18 years of age at enrollment who have single ventricle heart disease (SVHD) and have undergone a Fontan procedure. The study aims to find out how well udenafil works to improve the participant's ability to exercise and perform everyday activities. Since a common complication of SVHD is liver fibrosis (where normal liver tissue is replaced by abnormal scarring tissue which can lead to liver failure), this study will also look at how well udenafil could potentially help prevent or reduce liver fibrosis.
Approximately 436 people between the ages of 12 and 18 will participate in this study at approximately 60 sites worldwide
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
26/YH/0096
Date of REC Opinion
15 May 2026
REC opinion
Further Information Favourable Opinion