Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00418821
Status:
TERMINATED
Last Update Posted:
2024-02-20
First Post:
2007-01-03
Brief Title:
A Study of the Effect of Aldurazyme Laronidase Treatment on Lactation in Female Patients With Mucopolysaccharidosis I MPS I and Their Breastfed Infants
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Multinational Open-Label Study of the Effects of Aldurazyme Laronidase Treatment on Lactation in Women With Mucopolysaccharidosis I MPS I and Their Breastfed Infants
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was conducted to fulfill a post marketing commitment PMC FDA acknowledged closure of PMC
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if laronidase is present in the breast milk of post-partum women receiving Aldurazyme laronidase and the effects of Aldurazyme laronidase on the growth development and immunologic response of their breastfed infants
Detailed Description:
Recruitment is not limited to the facility listed facilities not yet active may be added upon identification of a patient
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 |
|---|---|---|---|
| ALID01803 | OTHER | company study code | None |
| 2007-007003-33 | EUDRACT_NUMBER | None | None |