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

• ClinicalTrials.gov Identifier: NCT00373061
• Recruitment Status: Completed
• First Posted: September 7, 2006
• Last Update Posted: February 14, 2018
• Sponsor: Genentech, Inc.
• Collaborator: Novartis
• Information provided by (Responsible Party): Genentech, Inc.

Tracking Information

• First Submitted Date: September 5, 2006
• First Posted Date: September 7, 2006
• Last Update Posted Date: February 14, 2018
• Actual Study Start Date: October 20, 2006
• Actual Primary Completion Date: December 11, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 3, 2017)

• 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) ]

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: October 3, 2017)

• 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) ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Asthma

Intervention

Drug: Xolair®

This being an observational study, the study protocol does not specify any dose regimen.

Other Name: Omalizumab

Study Groups/Cohorts

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®

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 3, 2017): 309
• Original Enrollment (submitted: September 5, 2006): 250
• Actual Study Completion Date: January 5, 2018
• Actual Primary Completion Date: December 11, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00373061
• Other Study ID Numbers: Q2952g
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Genentech, Inc.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Genentech, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Novartis

Investigators

• Study Director: Clinical Trials Hoffmann-La Roche; Hoffmann-La Roche

• PRS Account: Genentech, Inc.
• Verification Date: February 2018