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Udenafil for Single Ventricle Heart Disease (FUEL-2 Trial)

Phase 3
Recruiting
Research Sponsored by Mezzion Pharma Co. Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females with Fontan physiology who are 12 to less than 19 years of age at enrollment
Current antiplatelet or anticoagulant therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 26 weeks
Awards & highlights

FUEL-2 Trial Summary

This trial will test a drug to help adolescents who had a specific heart surgery.

Who is the study for?
Adolescents aged 12-18 with Fontan physiology, fluent in the study country's primary language, on antiplatelet or anticoagulant therapy can join. Excluded are those under 132 cm tall, pregnant females or not using contraception, recent heart failure hospitalization, severe ventricular dysfunction, and certain medication users.Check my eligibility
What is being tested?
The trial is testing Udenafil against a placebo to see if it's safe and effective for teens who've had the Fontan procedure. Participants will be randomly assigned to either receive Udenafil or a placebo for comparison.See study design
What are the potential side effects?
Udenafil may cause side effects similar to other PDE5 inhibitors like headaches, flushing of the face, nasal congestion, heartburn and potentially serious reactions affecting cardiovascular function.

FUEL-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 18 years old with Fontan physiology.
Select...
I am currently on blood thinner medication.

FUEL-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Exercise Capacity
Secondary outcome measures
Change in Enhanced Liver Fibrosis (ELF) Score
Change in VO2 at the ventilatory anaerobic threshold (VAT)
Change in ventilatory efficiency (VE/VCO2) at ventilatory anaerobic threshold
+1 more

FUEL-2 Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Approximately 218 subjects dosed with matching placebo will be enrolled at approximately 30 sites.
Group II: DrugExperimental Treatment1 Intervention
Approximately 218 subjects dosed with udenafil will be enrolled at approximately 30 sites.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Udenafil
2016
Completed Phase 4
~2380
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Mezzion Pharma Co. LtdLead Sponsor
4 Previous Clinical Trials
836 Total Patients Enrolled
2 Trials studying Single Ventricle Heart Disease
500 Patients Enrolled for Single Ventricle Heart Disease
John Hariadi, MDStudy DirectorMezzion Pharma Co. Ltd

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Drug been recognized by the FDA?

"Our assessment of Drug's safety received a 3, as Phase 3 trials provide ample evidence for both efficacy and security."

Answered by AI

Does my profile match the criteria for participating in this trial?

"This clinical investigation is searching for 436 participants with single ventricle heart disease that fall within the 12-18 age range."

Answered by AI

Are there any opportunities for individuals to participate in this trial?

"Indeed, the clinical trial is still recruiting patients as per information present on clinicaltrials.gov. It was originally posted in October of 2023 and recently updated to reflect its continuing search for participants."

Answered by AI

Does this trial involve elderly persons aged 60 or above?

"The requirements state that qualified applicants for this study must range between 12 and 18 years old. According to the research, there are 104 studies for minors while 249 exist for elderly people above 65."

Answered by AI

How many participants are participating in this research endeavor?

"Absolutely. Clinicaltrials.gov displays that this clinical investigation is currently seeking participants, with the initial posting taking place on October 30th 2023. A total of 436 individuals are needed to take part in the trial at one medical site and recent updates were made to the same date as its launch."

Answered by AI

Who else is applying?

What site did they apply to?
MUSC Pediatric Research Group
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
2023. "Fontan Udenafil Exercise Longitudinal Assessment Trial - 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05918211.
~291 spots leftby Oct 2025
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