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NCT03430583 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness
A Phase 3 study, sponsored by Mezzion Pharma Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 88
- Enrollment target
NCT03430583: Completed Phase 3 study, sponsored by Mezzion Pharma Co..
NCT03430583 is a Phase 3 study that has completed, run by Mezzion Pharma Co.. The registered enrollment target is 88 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03430583, a Phase 3 study, has completed, sponsored by Mezzion Pharma Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 88 participants
- Enrollment target
Study Summary
A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.
Primary Outcome
Liver stiffness was measured at baseline and 52 weeks using Ultrasound Shear Wave Elastography (USWE) separately in Udenafil Continuation (U+) and Udenafil Naive (U-) groups. A decrease in value indicates a decrease in liver stiffness.
Interventions
- DRUG Udenafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2018-02-20 |
| Est. Completion | 2020-09-16 |
| Phase | Phase 3 |
What the finished NCT03430583 record still lists
NCT03430583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Udenafil is the first listed.
NCT03430583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03430583 about?
NCT03430583 is a clinical study titled "Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness". A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.
What is the current status of trial NCT03430583?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 88 participants. The study started on 2018-02-20. Estimated completion is 2020-09-16.
What interventions are being tested in trial NCT03430583?
The interventions under investigation include: Udenafil (DRUG).
Who is sponsoring clinical trial NCT03430583?
This trial is sponsored by Mezzion Pharma Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03430583's enrollment target sits among peer trials
88 1739th of 2000 higher than 259 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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