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International Collaborative Gaucher Group (ICGG) Gaucher Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00358943
Recruitment Status : Recruiting
First Posted : August 1, 2006
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:

The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

The objectives of the Registry are:

  • To enhance the understanding of the variability, progression, and natural history of Gaucher disease with the ultimate goal of better guiding and assessing therapeutic interventions;
  • To provide the Gaucher medical community with recommendations for monitoring patients and to provide reports on patient outcomes to help optimize patient care; and
  • To evaluate the long-term effectiveness of Cerezyme.

Condition or disease
Gaucher Disease Cerebroside Lipidosis Syndrome Glucocerebrosidase Deficiency Disease Glucosylceramide Beta-Glucosidase Deficiency Disease

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Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Collaborative Gaucher Group (ICGG) Gaucher Registry
Actual Study Start Date : April 1991
Estimated Primary Completion Date : January 31, 2034
Estimated Study Completion Date : January 31, 2034





Primary Outcome Measures :
  1. To provide the Gaucher medical community with recommendations for monitoring patients and to provide reports on patient outcomes to help optimize patient care. [ Time Frame: For duration of the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Gaucher disease
Criteria

Inclusion Criteria:

  • All patients with a confirmed diagnosis of Gaucher disease are eligible for inclusion in the Registry. Confirmed diagnosis is defined as a documented β-glucocerebrosidase deficiency and/or mutation in the β-glucocerebrosidase gene.
  • For all patients, appropriate patient authorization will be obtained.

Exclusion Criteria:

  • No exclusion criteria for participation in the ICGG Gaucher Registry.NOTE: Registry participation does not exclude participation in other clinical studies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358943


Contacts
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Contact: For site information, send an email with site number to Contact-Us@sanofi.com
Contact: ICGG Gaucher Registry HelpLine +1 617-591-5500 help@gaucherregistry.com

Locations
Show Show 221 study locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Medical Monitor Genzyme, a Sanofi Company
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00358943    
Other Study ID Numbers: ICGG Gaucher Registry
DIREGC07009 ( Other Identifier: Sanofi )
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Gaucher Disease
Glucocerebrosidase Deficiency Disease
Additional relevant MeSH terms:
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Gaucher Disease
Lipidoses
Deficiency Diseases
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
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders
Malnutrition
Nutrition Disorders