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

Completed

• Conditions: Asthma
• Interventions: Drug: Xolair®

• Registration Number: NCT00373061
• Lead Sponsor: Genentech, Inc.

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 available

Study Timeline

• Study First Submitted: 2006-09-05
• Study First Submitted QC: 2006-09-05
• Study First Posted: 2006-09-07
• Study Start: 2006-10-20
• Primary Completion: 2017-12-11
• Study Completion: 2018-01-05
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 309

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Women Exposed to Xolair®	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.

Primary Outcome Measures

Name	Time	Method
Number of Fetal Deaths or Stillbirths	At Delivery (up to approximately 9 months after enrollment)
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 Congenital Birth Anomalies	At Delivery (up to approximately 9 months after enrollment)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ppd Development, Llc; 🇺🇸 Morrisville, North Carolina, United States