Status:
COMPLETED
An Observational Study of the Use and Safety of Xolair® During Pregnancy
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Novartis
Conditions:
Asthma
Eligibility:
FEMALE
Brief Summary
The Xolair® Pregnancy Registry is an observational study established by Genentech to obtain data on pregnancy outcomes in women who are exposed to Xolair®. Women exposed to at least one dose of Xolair...
Eligibility Criteria
Inclusion
- \- Women who have been exposed to at least one dose of Xolair® (whether inadvertent or deliberate) within 8 weeks prior to conception or during pregnancy
Exclusion
- Women not currently pregnant
- Women exposed to Xolair® not during pregnancy but only while breastfeeding
- Re-enrollment of women who are pregnant for second (or more) time is not allowed
Key Trial Info
Start Date :
October 20 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 5 2018
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT00373061
Start Date
October 20 2006
End Date
January 5 2018
Last Update
February 14 2018
Active Locations (1)
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1
Ppd Development, Llc
Morrisville, North Carolina, United States, 27560-7200