Status:
ACTIVE_NOT_RECRUITING
Metformin Use in Cardiac Fibrosis in PAI-1 Deficiency
Lead Sponsor:
Indiana Hemophilia &Thrombosis Center, Inc.
Conditions:
Plasminogen Activator Inhibitor-1 Deficiency
Cardiac Fibrosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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, fo...
Detailed Description
This study is a phase 4, prospective, open-label, US single center study to assess the efficacy and safety of metformin for prevention or stabilization or regression of cardiac fibrosis in individuals...
Eligibility Criteria
Inclusion
- Confirmed homozygosity for mutation in SERPINE-1 for PAI-1 deficiency
- Male or female
- Aged 18-65 years
- Willing and able to choose between being in a metformin Treatment group (daily metformin) or an Observation group (no study drug) at study entry
- Capable of understanding and willing to comply with the conditions of the study (in the opinion of the study investigator(s))
- Have read, understood and be able to provide written informed consent
Exclusion
- Not homozygous for SERPINE-1 mutation for PAI-1 deficiency, based on genetic testing
- Ages \<18 or \>65 years
- Renal dysfunction (Cockcroft Gault CrCl \< 30)
- History of hypersensitivity of metformin or any component in the extended release formulation
- Unwillingness to avoid alcohol
- Currently prescribed cimetidine, dolutegravir, patiromer, ranolazine, or tafenoquine and no alternate therapy is possible
- History of illicit drug or alcohol abuse within 48 weeks prior to screening, in the study investigators' judgment
- Concomitant disease, condition, significant abnormality on screening evaluations or laboratory tests, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the study investigator(s), pose an additional unacceptable risk in administering study drug to the patient
- Receipt of any other investigational medicinal product currently being administered (or planned to be administered)
- Inability to comply with the study protocol (in the opinion of the study investigator(s))
- Inability to understand and provide written informed consent
Key Trial Info
Start Date :
October 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05317806
Start Date
October 10 2022
End Date
October 1 2027
Last Update
November 6 2024
Active Locations (1)
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1
Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, United States, 46260