Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT05317806
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05317806
Study Brief:
Protocol Section:
NCT05317806