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Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01206673
First received: September 21, 2010
Last updated: December 1, 2011
Last verified: December 2011
History of Changes
  Purpose

The aim of this study is to evaluate macrophaging activity and immunologic profile of patients with Gaucher 's disease. For this, one blood sampling will be performed.


Condition Intervention
Patients With Gaucher's Disease
 Other: Blood sampling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • To determine the implication of acquired and inherent immunity in the Gaucher's clinical phenotype at moment of blood sampling [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to find new activity mark for Gaucher's disease by studying macrophagic activation's markers. [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: December 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Blood sampling
    One blood sampling is required for the research
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (age equal or above 18.
  • Patients with Gaucher 's disease treated in the "Grand Ouest" competence center
  • patients affiliated to social security
  • Informed consent signed

Exclusion Criteria:

- Children (age<18)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206673

Locations
France
Nantes Hospital
Nantes, France, 44093
CHU of Rennes
Rennes, France, 35
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01206673     History of Changes
Other Study ID Numbers: 09/07-I
Study First Received: September 21, 2010
Last Updated: December 1, 2011
Health Authority: France: AFSSAPS

Additional relevant MeSH terms:
Gaucher Disease
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 22, 2013