Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373061
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2006-09-05
Brief Title:
An Observational Study of the Use and Safety of Xolair During Pregnancy
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
The Xolair Pregnancy Registry An Observational Study of the Use and Safety of Xolair Omalizumab During Pregnancy
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPECT
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 within 8 weeks prior to conception or at any time during their pregnancy will be followed to completion of their pregnancies The evaluation of infants will be conducted at birth and at 6-month intervals until the infants are 12 months old Follow-up of the infant will be extended until the infant is 18 months old if the woman continues Xolair treatment while breastfeeding
Detailed Description:
None
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