An Observational Study of the Use and Safety of Xolair® During Pregnancy
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/16/2018 |
| Start Date: | October 20, 2006 |
| End Date: | January 5, 2018 |
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 the infants are 12 months old. Follow-up of the
infant will be extended until the infant is 18 months old, if the woman continues Xolair®
treatment while breastfeeding.
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 the infants are 12 months old. Follow-up of the
infant will be extended until the infant is 18 months old, if the woman continues Xolair®
treatment while breastfeeding.
Inclusion Criteria:
- Women who have been exposed to at least one dose of Xolair® (whether inadvertent or
deliberate) within 8 weeks prior to conception or during pregnancy
Exclusion Criteria:
- Women not currently pregnant
- Women exposed to Xolair® not during pregnancy but only while breastfeeding
- Re-enrollment of women who are pregnant for second (or more) time is not allowed
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