The Xolair® Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy
Overview
- Phase
- Not Applicable
- Intervention
- Xolair®
- Conditions
- Asthma
- Sponsor
- Genentech, Inc.
- Enrollment
- 309
- Locations
- 1
- Primary Endpoint
- Number of Fetal Deaths or Stillbirths
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Pregnant Women Exposed to Xolair®
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.
Intervention: Xolair®
Outcomes
Primary Outcomes
Number of Fetal Deaths or Stillbirths
Time Frame: At Delivery (up to approximately 9 months after enrollment)
Number of Live Births
Time Frame: At Delivery (up to approximately 9 months after enrollment)
Number of Elective Terminations
Time Frame: At Delivery (up to approximately 9 months after enrollment)
Number of Congenital Birth Anomalies
Time Frame: At Delivery (up to approximately 9 months after enrollment)
Secondary Outcomes
- Gestational Age of Neonates/Infants(Up to approximately 9 months after enrollment)
- Weight of Neonates/Infants(At Delivery (up to approximately 9 months after enrollment))
- Number of Delivery Complications or Abnormalities(At Delivery (up to approximately 9 months after enrollment))
- Number of Infant Illnesses or Infections(Delivery (up to approximately 9 months after enrollment) to 18 months)
- 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)
- Head Circumference 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))
- Apgar Score of Neonates/Infants(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)