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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373061
First Posted: September 7, 2006
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
Genentech, Inc.
September 5, 2006
September 7, 2006
October 5, 2017
October 20, 2006
December 12, 2017   (Final data collection date for primary outcome measure)
  • 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 Fetal Deaths or Stillbirths [ 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) ]
Not Provided
Complete list of historical versions of study NCT00373061 on ClinicalTrials.gov Archive Site
  • Number of Spontaneous Abortions [ Time Frame: At Delivery (up to approximately 9 months after enrollment) ]
  • Number of Pregnancy Complications or Abnormalities [ Time Frame: Up to approximately 9 months after enrollment ]
  • Number of Delivery Complications or Abnormalities [ Time Frame: At Delivery (up to approximately 9 months after enrollment) ]
  • Gestational Age of Neonates/Infants [ Time Frame: Up to approximately 9 months after enrollment ]
  • Apgar Score of Neonates/Infants [ Time Frame: Delivery (up to approximately 9 months after enrollment) to 18 months ]
  • Number of Infant Illnesses or Infections [ Time Frame: Delivery (up to approximately 9 months after enrollment) to 18 months ]
  • Neonatal Platelet Count [ Time Frame: Delivery (up to approximately 9 months after enrollment) to 18 months ]
  • Weight of Neonates/Infants [ Time Frame: At Delivery (up to approximately 9 months after enrollment) ]
  • Length of Neonates/Infants [ Time Frame: At Delivery (up to approximately 9 months after enrollment) ]
  • Head Circumference of Neonates/Infants [ Time Frame: At Delivery (up to approximately 9 months after enrollment) ]
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An Observational Study of the Use and Safety of Xolair® During Pregnancy
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
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.
Asthma
Drug: Xolair®
This being an observational study, the study protocol does not specify any dose regimen.
Other Name: Omalizumab
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: Drug: Xolair®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
309
January 5, 2018
December 12, 2017   (Final data collection date for primary outcome measure)

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: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00373061
Q2952g
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Genentech, Inc.
Genentech, Inc.
Novartis
Study Director: Clinical Trials Hoffmann-La Roche Hoffmann-La Roche
Genentech, Inc.
September 2017