NCT00358943 International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry
| NCT ID | NCT00358943 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Genzyme, a Sanofi Company |
| Condition | Gaucher Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 12,000 participants |
| Start Date | 1991-04-01 |
| Primary Completion | 2034-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 12,000 participants in total. It began in 1991-04-01 with a primary completion date of 2034-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: \- No exclusion criteria for participation in the ICGG Gaucher Registry and Sub-registry.
Contact & Investigator
Trial Transparency email recommended (Toll free number for US & Canada)
✉ contact-us@sanofi.com📞 800-633-1610
Study Director
STUDY DIRECTOR
Genzyme, a Sanofi Company
Frequently Asked Questions
Who can join the NCT00358943 clinical trial?
This trial is open to participants of all sexes, studying Gaucher Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00358943 currently recruiting?
Yes, NCT00358943 is actively recruiting participants. Contact the research team at contact-us@sanofi.com for enrollment information.
Where is the NCT00358943 trial being conducted?
This trial is being conducted at Phoenix, United States, Tucson, United States, Little Rock, United States, Little Rock, United States and 11 additional locations.
Who is sponsoring the NCT00358943 clinical trial?
NCT00358943 is sponsored by Genzyme, a Sanofi Company. The principal investigator is Study Director at Genzyme, a Sanofi Company. The trial plans to enroll 12,000 participants.