Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230607
Status:
TERMINATED
Last Update Posted:
2024-04-10
First Post:
2005-09-29
Brief Title:
Study of the Effects of Fabrazyme Treatment on Lactation and Infants
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Multinational Study of the Effects of Fabrazyme Agalsidase Beta Treatment on Lactation and Infants
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Per FDA decision the 2003 Post Marketing commitment has been fulfilled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study was planned for up to 2 years 24 months Planned full participation for both mother and infant was 24 months planned full participation of mother and development of infant was 24 months while planned full participation of mother and no infant participation was 6 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2006-001910-33 | EUDRACT_NUMBER | None | None |
| MSC12868 | OTHER | Sanofi | None |