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

Study Overview
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Brief Summary
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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.

Official Title
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The Xolair® Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy

Conditions
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Asthma

Intervention / Treatment
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* Drug: Xolair®


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Women Exposed to Xolair®<br>Women who are 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. | Drug: Xolair®<br>* This being an observational study, the study protocol does not specify any dose regimen.<br>* Other names: Omalizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Live Births |  | At Delivery (up to approximately 9 months after enrollment) | 
| Number of Elective Terminations |  | At Delivery (up to approximately 9 months after enrollment) | 
| Number of Fetal Deaths or Stillbirths |  | At Delivery (up to approximately 9 months after enrollment) | 
| Number of Congenital Birth Anomalies |  | At Delivery (up to approximately 9 months after enrollment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Spontaneous Abortions |  | At Delivery (up to approximately 9 months after enrollment) | 
| Number of Pregnancy Complications or Abnormalities |  | Up to approximately 9 months after enrollment | 
| Number of Delivery Complications or Abnormalities |  | At Delivery (up to approximately 9 months after enrollment) | 
| Gestational Age of Neonates/Infants |  | Up to approximately 9 months after enrollment | 
| Apgar Score of Neonates/Infants |  | Delivery (up to approximately 9 months after enrollment) to 18 months | 
| Number of Infant Illnesses or Infections |  | Delivery (up to approximately 9 months after enrollment) to 18 months | 
| Neonatal Platelet Count |  | Delivery (up to approximately 9 months after enrollment) to 18 months | 
| Weight of Neonates/Infants |  | At Delivery (up to approximately 9 months after enrollment) | 
| Length of Neonates/Infants |  | At Delivery (up to approximately 9 months after enrollment) | 
| Head Circumference of Neonates/Infants |  | At Delivery (up to approximately 9 months after enrollment) |