Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144794
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2005-09-02
Brief Title:
Mucopolysaccharidosis I MPS I Registry
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Mucopolysaccharidosis I MPS I Registry
Status:
RECRUITING
Status Verified Date:
2024-06
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 Mucopolysaccharidosis I MPS I Registry is an ongoing observational database that tracks the outcomes of patients with MPS I The data collected by the MPS I Registry will provide information to better characterize the natural history and progression of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy such as Aldurazyme Recombinant Human Alpha-L-Iduronidase or other treatment modalities
The objectives of the Registry are
To evaluate the long-term effectiveness and safety of Aldurazyme laronidase
To characterize and describe the MPS I population as a whole including the variability progression and natural history of MPS I
To help the MPS I medical community with the development of recommendations for monitoring patients and reports on patient outcomes to optimize patient care
The objectives of the Registry are
To evaluate the long-term effectiveness and safety of Aldurazyme laronidase
To characterize and describe the MPS I population as a whole including the variability progression and natural history of MPS I
To help the MPS I medical community with the development of recommendations for monitoring patients and reports on patient outcomes to optimize patient care
Detailed Description:
The MPS I Registry is an international program in addition to the central contact information provided under the Location heading patients may contact
In Asia-Pacific - Vivian Liu 65-6431-2548 Vivianliugenzymecom
In Europe - 31-35-699-1232 europempsiregistrycom
In Latin America - 617-591-5500 helpmpsiregistrycom
In North America - 617-591-5500 helpmpsiregistrycom
In Asia-Pacific - Vivian Liu 65-6431-2548 Vivianliugenzymecom
In Europe - 31-35-699-1232 europempsiregistrycom
In Latin America - 617-591-5500 helpmpsiregistrycom
In North America - 617-591-5500 helpmpsiregistrycom
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 |
|---|---|---|---|
| U1111-1294-8266 | REGISTRY | ICTRP | None |