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NCT05317806 · ClinicalTrials.gov registry record · Phase 4
Metformin Use in Cardiac Fibrosis in PAI-1 Deficiency
A Phase 4 study of Plasminogen Activator Inhibitor-1 Deficiency and Cardiac Fibrosis, sponsored by Indiana Hemophilia &Thrombosis Center.
- Active
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05317806: Active Phase 4 study of Plasminogen Activator Inhibitor-1 Deficiency and Cardiac Fibrosis, sponsored by Indiana Hemophilia &Thrombosis Center.
NCT05317806 is a Phase 4 study of Plasminogen Activator Inhibitor-1 Deficiency and Cardiac Fibrosis that is active but no longer recruiting, run by Indiana Hemophilia &Thrombosis Center. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05317806, a Phase 4 study of Plasminogen Activator Inhibitor-1 Deficiency and Cardiac Fibrosis, is active but no longer recruiting, sponsored by Indiana Hemophilia &Thrombosis Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the efficacy and safety of metformin, in patients 18-65 years of age with homozygous plasminogen activator inhibitor-1 (PAI-1) deficiency, with or without cardiac fibrosis, for a period of 60 months. The starting dose of metformin will be 500 mg up to a maximum dose of 2000 mg for a period of 5 years with the aim to assess the safety and efficacy of metformin on prevention/stabilization or regression of cardiac fibrosis in a Treated population vs. a Comparison population.
Primary Outcome
Measured using cardiac MRI to quantify the percentage cardiac fibrosis.
Conditions Studied
Interventions
- DRUG Metformin Extended Release Oral Tablet
Study Locations (1)
Indiana
- Indiana Hemophilia and Thrombosis Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-10-10 |
| Est. Completion | 2027-10 |
| Phase | Phase 4 |
What the registry record for NCT05317806 still lists
NCT05317806 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Plasminogen Activator Inhibitor-1 Deficiency appearing as the primary indexed condition, and to 1 intervention - of which Metformin Extended Release Oral Tablet is the first listed.
NCT05317806 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT05317806 about?
NCT05317806 is a clinical study titled "Metformin Use in Cardiac Fibrosis in PAI-1 Deficiency". This study will evaluate the efficacy and safety of metformin, in patients 18-65 years of age with homozygous plasminogen activator inhibitor-1 (PAI-1) deficiency, with or without cardiac fibrosis, for a period of 60 months. The starting dose of metformin will be 500 mg up to a maximum dose of 2000 ...
What is the current status of trial NCT05317806?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2022-10-10. Estimated completion is 2027-10.
What conditions does trial NCT05317806 study?
This clinical trial studies the following conditions: Plasminogen Activator Inhibitor-1 Deficiency, Cardiac Fibrosis.
What interventions are being tested in trial NCT05317806?
The interventions under investigation include: Metformin Extended Release Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT05317806?
This trial is sponsored by Indiana Hemophilia &Thrombosis Center, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05317806 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05317806's enrollment target sits among peer trials
15 1881st of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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