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Status:

COMPLETED

A Non-Interventional National Study in Pediatric Patients With Unexplained Enlarged Spleen

Lead Sponsor:

Sanofi

Conditions:

Gaucher Disease, Splenomegaly

Acid SphingoMyelinase Deficiency

Eligibility:

All Genders

Up to 18 years

Brief Summary

Primary Objective: To assess prevalence of Gaucher disease (GD) diagnosed in pediatric patients presenting with unexplained splenomegaly (SMG) after exclusion of first intention-diagnoses (e.g. porta...

Detailed Description

The planned duration of this study is 39 months, which includes 36 months of patient recruitment.

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Patient under the age of 18 years
  • Patient with unexplained SMG (SMG defined as a palpable spleen, already known or discovered for the first time) and who has undergone tests to eliminate obvious causes of SMG
  • Exclusion criteria:
  • Patient with any obvious cause of SMG as described by clinical examination and/or lab or imaging test available in medical records and/or having been diagnosed with any of the following conditions:
  • hemolytic anemia
  • hematological malignancy
  • portal hypertension
  • infectious disease associated with SMG (Cytomegalovirus, Epstein Barr virus, leishmaniasis or other obvious infectious cause revealed by the medical history)
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Exclusion

    Key Trial Info

    Start Date :

    June 30 2021

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    November 25 2024

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT04845958

    Start Date

    June 30 2021

    End Date

    November 25 2024

    Last Update

    September 23 2025

    Active Locations (40)

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    Page 1 of 10 (40 locations)

    1

    Investigational Site Number 2500036

    Amiens, France, 80054

    2

    Investigational Site Number 2500014

    Angers, France, 49933

    3

    Investigational Site Number 2500034

    Argenteuil, France, 95107

    4

    Investigational Site Number 2500039

    Bayonne, France, 64100