Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-29 @ 9:21 PM
Study NCT ID:
NCT00373061
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2006-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of the Use and Safety of Xolair® During Pregnancy
Sponsor:
Genentech, Inc.
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: