International Collaborative Gaucher Group (ICGG) Gaucher Registry
Information source: Genzyme
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gaucher Disease; Cerebroside Lipidosis Syndrome; Glucocerebrosidase Deficiency Disease; Glucosylceramide Beta-Glucosidase Deficiency Disease
Phase: N/A
Status: Recruiting
Sponsored by: Genzyme Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme
Overall contact:
ICGG Gaucher Registry HelpLine, Phone: 800-745-4447, Ext: x15500, Email: help@gaucherregistry.com
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 enzyme replacement therapy (ERT).
Clinical Details
Official title: International Collaborative Gaucher Group (ICGG) Gaucher Registry
Study design: Other, Prospective
Detailed description:
The ICGG Gaucher Registry is an international program; in addition to the central contact
information provided under the "Location" heading, patients may contact:
- In Asia-Pacific - Margie Jimenez, +852 2810 1613
- In Europe - +31-35-699-1232, europe@gaucherregistry. com
- In Latin America - +617-591-5500, help@gaucherregistry. com
- In North America - +617-591-5500, help@gaucherregistry. com
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
ICGG Gaucher Registry HelpLine, Phone: 800-745-4447, Ext: x15500, Email: help@gaucherregistry.com
Registry participation is worldwide and not limited to this facility; facilities not yet active may enroll upon identification of a patient., Cambridge, Massachusetts 02142, United States; Recruiting
Additional Information
Starting date: April 1991
Last updated: October 7, 2009
|
