Status:
TERMINATED
AMEVIVE® Pregnancy Registry
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Pregnancy
Eligibility:
FEMALE
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 fe...
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 month...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
December 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00342862
Start Date
December 1 2003
End Date
December 1 2011
Last Update
December 11 2013
Active Locations (1)
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1
INC Research
Wilmington, North Carolina, United States, 28405