Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454701
Status:
TERMINATED
Last Update Posted:
2013-12-11
First Post:
2007-03-29
Brief Title:
Assessment and Tracking of Long-term Alefacept Safety
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
Assessment and Tracking of Long-term Alefacept LFA-3IgG1 Fusion Protein Safety ATLAS
Status:
TERMINATED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Sponsor has made a decision driven by business needs to cease promotion manufacturing distribution and sales of Amevive
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATLAS
Brief Summary:
Subjects exposed to alefacept are to be enrolled Subjects will be contacted every 6 months to gather general health information
Detailed Description:
There are no study-mandated tests visits or clinical interventions after the 1st enrolling visit After the patient is enrolled in the study they will be contacted every 6 months to complete structured telephone interviews conducted by the ATLAS Study Center
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 |
|---|---|---|---|
| C-736 | None | None | None |