Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146757
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2005-09-02
Brief Title:
A Study Evaluating the Safety and Pharmacokinetics of Aldurazyme Laronidase in MPS I Patients Less Than 5 Years Old
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase II Open-Label Clinical Trial of Recombinant Human Alpha-L-iduronidase Aldurazyme to Evaluate the Safety and Pharmacokinetics in Mucopolysaccharidosis I MPS I Patients Less Than 5 Years Old
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:
The main objectives of this study are to evaluate the safety and pharmacokinetics PK of enzyme replacement therapy with recombinant human alpha-L-iduronidase Aldurazyme laronidase in mucopolysaccharidosis I MPS I patients less than 5 years old Efficacy measurements will also be evaluated 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