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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00373061
First received: September 5, 2006
Last updated: March 8, 2016
Last verified: March 2016
  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:


Further study details as provided by Genentech, Inc.:

Enrollment: 304
Study Start Date: October 2006
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Genentech Trial Information Support Line
South San Francisco, California, United States, 94080
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00373061     History of Changes
Other Study ID Numbers: Q2952g 
Study First Received: September 5, 2006
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
Expect

Additional relevant MeSH terms:
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 27, 2016