Clinical trial NCT00373061: An Observational Study of the Use and Safety of Xolair® During Pregnancy
Official title: The Xolair® Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2006-09-07
Enrollment: 309
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: Number of Live Births
timeFrame: At Delivery (up to approximately 9 months after enrollment)
measure: Number of Elective Terminations
timeFrame: At Delivery (up to approximately 9 months after enrollment)
measure: Number of Fetal Deaths or Stillbirths
timeFrame: At Delivery (up to approximately 9 months after enrollment)
measure: Number of Congenital Birth Anomalies
timeFrame: At Delivery (up to approximately 9 months after enrollment)
Secondary outcomes:
measure: Number of Spontaneous Abortions
timeFrame: At Delivery (up to approximately 9 months after enrollment)
measure: Number of Pregnancy Complications or Abnormalities
timeFrame: Up to approximately 9 months after enrollment
measure: Number of Delivery Complications or Abnormalities
timeFrame: At Delivery (up to approximately 9 months after enrollment)
measure: Gestational Age of Neonates/Infants
timeFrame: Up to approximately 9 months after enrollment
measure: Apgar Score of Neonates/Infants
timeFrame: Delivery (up to approximately 9 months after enrollment) to 18 months
measure: Number of Infant Illnesses or Infections
timeFrame: Delivery (up to approximately 9 months after enrollment) to 18 months
measure: Neonatal Platelet Count
timeFrame: Delivery (up to approximately 9 months after enrollment) to 18 months
measure: Weight of Neonates/Infants
timeFrame: At Delivery (up to approximately 9 months after enrollment)
measure: Length of Neonates/Infants
timeFrame: At Delivery (up to approximately 9 months after enrollment)
measure: Head Circumference of Neonates/Infants
timeFrame: At Delivery (up to approximately 9 months after enrollment)
Other outcomes:
Locations:
city: Morrisville
country: United States
facility: Ppd Development, Llc
state: North Carolina
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials Hoffmann-La Roche
role: STUDY_DIRECTOR
References: