Status:
COMPLETED
Autoimmune and Inflammatory Response Biomarkers in Fabry Disease
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborating Sponsors:
Fundación Mutua Madrileña
Conditions:
Fabry Disease
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this observational study is to understand the immune response in Fabry disease (FD). We want to find out how the immune response is related to the severity of FD and how it affects patient...
Detailed Description
Rationale: The immune response could play a relevant role in the pathophysiological mechanisms of Fabry disease (FD), although the relationship between the activated immune pathways and the clinical e...
Eligibility Criteria
Inclusion
- For the Fabry Disease (FD) group:
- Age ≥ 18 years.
- Diagnosis of Fabry disease (enzymatic or genetic).
- Having signed the informed consent, after having received all the information concerning the study.
Exclusion
- Autoimmune or autoinflammatory disease or patients with transplanted organs (corneal transplant excluded) and under additional immunosuppressive treatment.
- Acute cardiovascular event or major surgery in the 90 days prior to inclusion in the study.
- Serious intercurrent diseases such as HIV, COVID-19, cancer under active treatment, severe anemia, severe hepatic, respiratory or renal failure, or other pathologies that, at the investigator's discretion, could interfere with the objectives of the study.
- For the Control group:
- • Participants must not meet any of the exclusion criteria applied to the target (FD) population and must sign, prior to inclusion, the informed consent form after having received all the information concerning the study.
Key Trial Info
Start Date :
September 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 27 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06007768
Start Date
September 20 2022
End Date
April 27 2023
Last Update
March 17 2025
Active Locations (1)
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1
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28034