International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry

  • STATUS
    Recruiting
  • End date
    Jan 31, 2034
  • participants needed
    12000
  • sponsor
    Genzyme, a Sanofi Company
Updated on 22 July 2020
Investigator
For site information, send an email with site number to
Primary Contact
Investigational Site Number 151431 (7.5 mi away) Contact
+219 other location
imiglucerase
eliglustat

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 understanding of the variability, progression, identification, and natural history of Gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention.
  • To assist the Gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care.
  • To characterize the Gaucher disease population.
  • To evaluate the long-term effectiveness of imiglucerase and of eliglustat.

Gaucher Pregnancy Sub-registry: The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.

Details
Clinical Study IdentifierNCT00358943
SponsorGenzyme, a Sanofi Company
Last Modified on22 July 2020

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Eligibility

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Inclusion Criteria

Gender: Male or Female
Do you have Gaucher Disease?
ICGG Gaucher Registry
All patients with a confirmed diagnosis of Gaucher disease are eligible for inclusion in the Registry. Confirmed diagnosis is defined as a documented -glucocerebrosidase deficiency and/or mutation in the -glucocerebrosidase gene
For all patients, appropriate patient authorization will be obtained
Gaucher Pregnancy Sub-registry
be enrolled in the ICGG Gaucher Registry
be pregnant, or have been pregnant with appropriate medical documentation available
provide a signed informed consent and authorization form(s) to participate in the Sub-Registry prior to any Sub-Registry-related data collection being performed

Exclusion Criteria

No exclusion criteria for participation in the ICGG Gaucher Registry and Sub-registry
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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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