Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342862
Status:
TERMINATED
Last Update Posted:
2013-12-11
First Post:
2006-06-19
Brief Title:
AMEVIVE Pregnancy Registry
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
Assessment and Tracking of Long-Term Alefacept LFA-3IgG1 Fusion Protein Pregnancy Exposure Registry
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:
None
Brief Summary:
This is an observational exposure-registration and follow-up study to be conducted in the United States US The AMEVIVE Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses exposed to AMEVIVE in order to detect any potential increase in the risk of major birth defects
The AMEVIVE Pregnancy Exposure Registry is sponsored by Astellas Pharma Global Development and will be managed by INC Research The Registry will be monitored by an independent Advisory Committee of external experts in relevant specialties of teratology epidemiology maternal and fetal medicine and infectious disease medicine external member details available upon request
The AMEVIVE Pregnancy Exposure Registry is sponsored by Astellas Pharma Global Development and will be managed by INC Research The Registry will be monitored by an independent Advisory Committee of external experts in relevant specialties of teratology epidemiology maternal and fetal medicine and infectious disease medicine external member details available upon request
Detailed Description:
Prospective reports will be collected from pregnant subjects health care provider HCP or Astellas Product Safety Management staff Data from the pregnant subjects will be collected at 4 to 5 months of pregnancy by telephone interviews with the Registry The Registry will also contact the subject at 2 months and 12 months after the estimated delivery date EDD for post-natal pediatric follow-up The Registry will confirm the information collected from the subject with the HCP by telephone interviews with the Registry forms mailedfaxed to the Registry electronic formsqueries sent to the Registry or a combination of these methods If a live birth is reported the infants HCP will be contacted for the Pediatric Follow-Up at 2 months and 12 months of age If a birth defect is reported targeted follow-up will be conducted
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-739 | None | None | None |