An Observational Study of the Use and Safety of Xolair During Pregnancy

This study is currently recruiting participants.

Verified by Genentech, November 2006

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00373061

Purpose

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.

Condition	Phase
Asthma	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	The Xolair Pregnancy Registry: An Observational Study of the Use and Safety of Xolair (Omalizumab) During Pregnancy (EXPECT)

Further study details as provided by Genentech:

Estimated Enrollment:	250
Study Start Date:	October 2006

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373061

Contacts

Contact: Trial Information Support Line

866-496-5247 ext 3

Locations

United States, California
Genentech Trial Information Support Line	Recruiting
South San Francisco, California, United States, 94080
Contact 866-496-5247 ext 3

Sponsors and Collaborators

Genentech

Investigators

Study Director:

John Thorp, M.D.

PPD

More Information

Study ID Numbers:	Q2952g
Study First Received:	September 5, 2006
Last Updated:	November 9, 2006
ClinicalTrials.gov Identifier:	NCT00373061
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Expect

Study placed in the following topic categories:

Asthma
Omalizumab

ClinicalTrials.gov processed this record on January 14, 2009