Status:
RECRUITING
Study of Individuals Affected With Hypoplasminogenemia
Lead Sponsor:
Indiana Hemophilia &Thrombosis Center, Inc.
Collaborating Sponsors:
Fondazione Angelo Bianchi Bonomi
Conditions:
Plasminogen Deficiency
Eligibility:
All Genders
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 understandin...
Detailed Description
The aims of this study are to: 1. Define PLGD natural history in a large cohort of individuals with hypoplasminogenemia and their first-degree family members. 2. Identify factors that correlate with ...
Eligibility Criteria
Inclusion
- Signed informed consent and assent as applicable (Appendix 1)
- 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)
- All ages included
- Available clinical history and treatment for at least 1 year prior to entry except for infants \< 1 year of age
- Willingness to provide samples for analysis including DNA, plasma etc.
- Willingness to participate in prospective follow-up for up to 3 years
Exclusion
- Previous organ transplant recipient
- 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
- Refuses to provide informed consent
- Special patient populations, including prisoners or, are deemed medically or cognitively unsuitable for research by their treating physician
- Inability to obtain a blood sample due to poor or limited venous access
Key Trial Info
Start Date :
December 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 19 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03797495
Start Date
December 18 2018
End Date
April 19 2027
Last Update
August 28 2025
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Alabama (UAB)
Birmingham, Alabama, United States, 35233
2
Rush University Medical Center
Chicago, Illinois, United States, 60612
3
Indiana Hemophila @Thrombosis Center
Indianapolis, Indiana, United States, 46260
4
University of Minnesota, Pediatric Hem/Onc & Cancer Survivorship Program
Minneapolis, Minnesota, United States, 55455