CompletedPhase 3

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

United States88 participantsStarted 2018-02-20

Plain-language summary

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

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Enrollment in on-going Phase 3 Open-Label Safety Study
✓. Informed assent from subject, informed consent from parent/legal guardian as appropriate

Exclusion criteria

✕. Non-enrollment in the on-going Phase 3 Open-Label Study
✕. Subjects with contra-indications for MRI (these subjects will be excluded from the MRI component of this study)
✕. Other exclusionary criteria will match those used for the Open-Label Safety Study

What they're measuring

Effect of Udenafil 87.5 mg BID Treatment on Liver Stiffness in Udenafil Continuation and Naive Groups After 52 Weeks, as Determined by Ultrasound Shear Wave Elastography

Timeframe: 52 weeks

Effect of Udenafil 87.5 mg BID Treatment on Liver Stiffness in Udenafil Continuation and Naive Groups After 52 Weeks, as Determined by Magnetic Resonance Elastography

Timeframe: 52 weeks

Trial details

NCT IDNCT03430583

SponsorMezzion Pharma Co. Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-09-15

Results submitted2025-08-24

View on ClinicalTrials.gov More Single Ventricle Heart Disease trials