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

This study is currently recruiting participants.
Verified December 2012 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00373061
First received: September 5, 2006
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  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 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Xolair Pregnancy Registry: An Observational Study of the Use and Safety of Xolair (Omalizumab) During Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources

Further study details as provided by Genentech:

Estimated Enrollment: 250
Study Start Date: October 2006
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00373061     History of Changes
Other Study ID Numbers: Q2952g
Study First Received: September 5, 2006
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Expect

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 13, 2013