Global Burden and Treatment Trajectiories in Italian Patients With Fabry Disease

Study Identifier:
DFIDM-2001
ClinicalTrials.gov Identifier:
NCT04916977
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Trial Documents

Clinical Study Report
Available Languages: English
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Plain Language Summary
Available Languages: English, Italian
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Study Details

Medical Condition
  • Fabry Disease
Study Drug
    Date
    Jun 2021 - Jun 2022
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: 18+ years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Adult patients living or deceased of either sex (age ≥18 years) with a documented FD diagnosis in the last 10 years from the beginning of the study.
    • Patients with at least 3 years of follow-up or early occurrence of severe/fatal outcomes. Also, adult patients who were lost by their care provider or physician and cannot be traced, but for which it is possible to retrieve data for at least 3 years before the last available follow-up visit or from diagnosis to the occurrence of severe/fatal outcomes if earlier, can be included.
    • Written informed consent to undergo in the cross-sectional protocol clinical visit and to retrospectively collect genetic/clinical data. In case of deceased or untraceable patients, the written informed consent is not required to collect retrospective clinical data (excluding genetic data).
    Exclusion Criteria
    • Not applicable
    Healthy Volunteers
    No

    Protocol Summary

    GROUND study is an Italian, multicenter retrospective longitudinal cohort study with a cross-sectional phase with the aim to quantify the severe clinical burden in terms of severe and fatal outcomes and extension of clinical impairment in the Italian Fabry Disease patients' population

    Study Locations

    Location
    Status
    Location
    AUSL Toscana Sud-Est - Ospedale San Donato
    Arezzo, Italy
    Status
    N/A
    Location
    A.O.U. Careggi
    Florence, Italy
    Status
    N/A
    Location
    U.O.C. Nefrologia ASST Monza - Ospedale San Gerardo
    Monza, Italy
    Status
    N/A
    Location
    U.O. di Nefrologia - Dipartimento di Sanità Pubblica Università degli Studi di Napoli "Federico II" NAPOLI
    Naples, Italy
    Status
    N/A
    Location
    A.O.U. Policlinico "Giaccone"
    Palermo, Italy
    Status
    N/A
    Location
    AUSL della Romagna - Ospedale Infermi
    Rimini, Italy
    Status
    N/A
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