An Observational Study of the Use and Safety of Xolair During Pregnancy (EXPECT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00373061
First received: September 5, 2006
Last updated: August 12, 2013
Last verified: August 2013

September 5, 2006
August 12, 2013
October 2006
August 2015   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00373061 on ClinicalTrials.gov Archive Site
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An Observational Study of the Use and Safety of Xolair During Pregnancy
The Xolair Pregnancy Registry: An Observational Study of the Use and Safety of Xolair (Omalizumab) During Pregnancy

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 infants are 12 months old.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Enrollment in the Xolair Pregnancy Registry is voluntary and must be initiated by the pregnant woman. A healthcare provider (HCP) cannot enroll a patient but can suggest that the pregnant woman call the Registry Center to enroll herself.

Asthma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
August 2015
August 2015   (final data collection date for primary outcome measure)

Eligibility for enrollment is based on Xolair exposure in women, whether inadvertent or deliberate, in relation to pregnancy. Women who have been exposed to at least one dose of Xolair within 8 weeks prior to conception or during pregnancy may be included in this registry.

Female
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Contact: Trial Information Support Line 866-496-5247 ext 3
United States
 
NCT00373061
Q2952g
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Genentech, Inc.
Genentech, Inc.
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Study Director: John Thorp, M.D. PPD
Genentech, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP