Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146770
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2005-09-02
Brief Title:
Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme Laronidase in Mucopolysaccharidosis I MPS I Patients
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Multinational Open-Label Extension Study of the Safety and Efficacy of Aldurazyme Laronidase in Patients With Mucopolysaccharidosis I
Status:
COMPLETED
Status Verified Date:
2015-03
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:
This study is being conducted to collect additional long-term efficacy and safety data of Aldurazyme laronidase patients with MPS I disease Patients who were previously enrolled in the Phase 3 Double-Blind Study will be enrolled in this study
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