An Observational Study of the Use and Safety of Xolair During Pregnancy (EXPECT)
Verified August 2013 by Genentech
Information provided by (Responsible Party):
First received: September 5, 2006
Last updated: August 12, 2013
Last verified: August 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||The Xolair Pregnancy Registry: An Observational Study of the Use and Safety of Xolair (Omalizumab) During Pregnancy
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2015 (Final data collection date for primary outcome measure)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
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
|Contact: Trial Information Support Line
||866-496-5247 ext 3
|Genentech Trial Information Support Line
|South San Francisco, California, United States, 94080 |
|Contact 866-496-5247 ext 3 |
||John Thorp, M.D.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 5, 2006
||August 12, 2013
||United States: Food and Drug Administration
Keywords provided by Genentech:
ClinicalTrials.gov processed this record on September 18, 2014