AMEVIVE® Pregnancy Registry
| Status: | Archived |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
AMEVIVE® (Alefacept) Pregnancy Registry
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 Kendle International. 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).
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 mailed/faxed
to the Registry, electronic forms/queries sent to the Registry, or a combination of these
methods. If a live birth is reported, the infant's 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.
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