NCT03797495 Study of Individuals Affected With Hypoplasminogenemia
| NCT ID | NCT03797495 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana Hemophilia &Thrombosis Center, Inc. |
| Condition | Plasminogen Deficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2018-12-18 |
| Primary Completion | 2029-06-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2018-12-18 with a primary completion date of 2029-06-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an Investigator initiated retrospective and prospective single cohort study. The study will utilize an international registry and develop a specimen biobank to provide an improved understanding of the natural history of hyposplasminogenemia, to elucidate the heterogeneity of phenotypic expression, identify markers to predict disease course, and inform improved therapeutic modalities
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent and assent as applicable (Appendix 1) 2. A. Males or females with type 1 PD diagnosed locally with plasminogen activity levels \<50% OR B. First degree family members of a person diagnosed with type 1 PD (includes parents, siblings, half-siblings) 3. All ages included 4. Available clinical history and treatment for at least 1 year prior to entry except for infants \< 1 year of age 5. Willingness to provide samples for analysis including DNA, plasma etc. 6. Willingness to participate in prospective follow-up for up to 3 years Exclusion Criteria: 1. Previous organ transplant recipient 2. Any psychiatric disorder, other mental disorder, or any other medical disorder that impairs the subject's ability to give informed consent or to comply with the requirements of the study protocol 3. Refuses to provide informed consent 4. Special patient populations, including prisoners or, are deemed medically or cognitively unsuitable for research by their treating physician 5. Inability to obtain a blood sample due to poor or limited venous access
Contact & Investigator
Amy D Shapiro, MD
PRINCIPAL INVESTIGATOR
Indiana Hemophilia &Thrombosis Center, Inc.
Frequently Asked Questions
Who can join the NCT03797495 clinical trial?
This trial is open to participants of all sexes, studying Plasminogen Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03797495 currently recruiting?
Yes, NCT03797495 is actively recruiting participants. Contact the research team at ashapiro@ihtc.org for enrollment information.
Where is the NCT03797495 trial being conducted?
This trial is being conducted at Birmingham, United States, Chicago, United States, Indianapolis, United States, Minneapolis, United States and 11 additional locations.
Who is sponsoring the NCT03797495 clinical trial?
NCT03797495 is sponsored by Indiana Hemophilia &Thrombosis Center, Inc.. The principal investigator is Amy D Shapiro, MD at Indiana Hemophilia &Thrombosis Center, Inc.. The trial plans to enroll 100 participants.