AMEVIVE® Pregnancy Registry

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Alefacept

Criteria

Inclusion Criteria:

• Have been exposed to AMEVIVE® within 8 weeks prior to conception or at any time during pregnancy

• Provide sufficient information to determine that the pregnancy is prospectively registered (i.e., the outcome of pregnancy must be unknown prospectively)

• Provide verbal consent to participate in the Registry, and

• Verbally provide the contact information for herself, her healthcare provider (HCP), and the infant's HCP (if applicable)

Exclusion Criteria:

• None