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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xolair® | Drug | This being an observational study, the study protocol does not specify any dose regimen. |
|
| 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) |
| 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 | |
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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:
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Women exposed to at least one dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy. Enrollment in the Xolair® Pregnancy Registry is voluntary and must be initiated by the pregnant woman. A healthcare provider cannot enroll a patient but can suggest that the pregnant woman call the Registry Center to enroll herself.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials Hoffmann-La Roche | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ppd Development, Llc | Morrisville | North Carolina | 27560-7200 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| 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) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |