Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358943
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2006-07-12
Brief Title:
International Collaborative Gaucher Group ICGG Gaucher Disease Registry Pregnancy Sub-registry
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Gaucher Disease Registry Protocol
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 patients physicianIf a patient consents to this Sub-registry information about the patients 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 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 patients physicianIf a patient consents to this Sub-registry information about the patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1295-5844 | REGISTRY | ICTRP | None |
| ICGG Gaucher Registry | OTHER | None | None |