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Understanding Hypoplasminogenemia and Its Effects

Hypoplasminogenemia: An International RetroSpecTive and PrOspective CohoRt StudY (HISTORY)

Observational Indiana Hemophilia &Thrombosis Center, Inc. · NCT03797495

This study is trying to learn more about hypoplasminogenemia by gathering information from people with the condition and their family members to see how it affects them and what factors might influence its severity.

Quick facts

Study typeObservational
Enrollment100 (estimated)
SexAll
SponsorIndiana Hemophilia &Thrombosis Center, Inc. Academic / other
Locations30 sites (Birmingham, Alabama and 29 other locations)
Trial IDNCT03797495 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the natural history of hypoplasminogenemia by collecting data from a large cohort of affected individuals and their first-degree family members. It will utilize both retrospective and prospective data collection methods, focusing on identifying factors that correlate with disease expression and severity. Additionally, a specimen biobank will be established to facilitate further research on this condition. The study will be conducted internationally, with primary data collection at the Indiana Hemophilia & Thrombosis Center and collaboration with the University of Milan.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with type 1 plasminogen deficiency and their first-degree family members, regardless of age.

Not a fit: Patients with previous organ transplants or those with psychiatric or cognitive disorders that impair their ability to consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of hypoplasminogenemia, potentially informing better therapeutic options for patients.

How similar studies have performed: While this study is focused on hypoplasminogenemia, similar observational studies have successfully advanced understanding of rare genetic conditions, suggesting potential for meaningful insights.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Plasminogen Deficiency
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.