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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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05317806
The ClinicalTrials.gov registry entry for NCT05317806 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana Hemophilia &Thrombosis Center, which has 4 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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