Taking people in CzechiaNo phase

Tracks outcomes of people with Gaucher disease, including during pregnancy

Follows people with Gaucher disease over time, with and without treatment, including pregnancy.

Key facts

Who runs it: Genzyme, a Sanofi Company
Where: Prague, CzechiaSee the siteAlso in 51 other countries, 316 sites
Trial code: NCT00358943
U1111-1295-5844
Registry title: International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry
Status: Recruiting
People taking part: 12,000 people, planned
Started: 1 Apr 1991
Expected to end: 31 Jan 2034
Type of study: Observational, 2 groups
Record updated: 14 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The registry is looking for people with a confirmed diagnosis of Gaucher disease, whether or not they take treatment. A pregnancy sub-registry covers women with Gaucher disease who are or were pregnant.

Sex: All sexes can join.
Disease stage: Gaucher disease confirmed by a documented β-glucocerebrosidase deficiency and/or a mutation in the β-glucocerebrosidase gene.
Earlier treatment: No treatment is required. People can join whatever their treatment status.
Biomarker or test result: Documented β-glucocerebrosidase deficiency and/or a mutation in the β-glucocerebrosidase gene.

Main reasons for not taking part

The record lists no exclusion criteria for the registry or the sub-registry.

The registry criteria, word for word

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Who can take part

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 β-glucocerebrosidase deficiency and/or mutation in the β-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

Who cannot take part

No exclusion criteria for participation in the ICGG Gaucher Registry and Sub-registry

Where in Czechia

Also in 51 other countries, 316 sites

PragueHospital not named in the registryContact: ICGG Gaucher Registry HelpLineTaking people

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

Patients in ICGG Gaucher Registry
No experimental intervention is given. A patient with Gaucher Disease will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.
Pregnant women with confirmed diagnosis of Gaucher disease
No experimental intervention is given. Pregnant women with confirmed diagnosis of Gaucher disease who are participating in the ICGG Gaucher Registry and consented to participate in the Gaucher Pregnancy Sub-registry, regardless of whether she is receiving disease-specific therapy and irrespective of the commercial product with which she may be treated.