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

Asthma Clinical Trial

— EXPECT  

Official title:

The Xolair® Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373061
• Other study ID #: Q2952g
• Status: Completed
• Phase: N/A
• First received: September 5, 2006
• Last updated: February 12, 2018
• Start date: October 20, 2006
• Est. completion date: January 5, 2018

Study information

• Verified date: February 2018
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: January 5, 2018
• Est. primary completion date: December 11, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Xolair®
This being an observational study, the study protocol does not specify any dose regimen.

Locations

Country	Name	City	State
United States	Ppd Development, Llc	Morrisville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Genentech, Inc.	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Live Births		At Delivery (up to approximately 9 months after enrollment)
Primary	Number of Elective Terminations		At Delivery (up to approximately 9 months after enrollment)
Primary	Number of Fetal Deaths or Stillbirths		At Delivery (up to approximately 9 months after enrollment)
Primary	Number of Congenital Birth Anomalies		At Delivery (up to approximately 9 months after enrollment)
Secondary	Number of Spontaneous Abortions		At Delivery (up to approximately 9 months after enrollment)
Secondary	Number of Pregnancy Complications or Abnormalities		Up to approximately 9 months after enrollment
Secondary	Number of Delivery Complications or Abnormalities		At Delivery (up to approximately 9 months after enrollment)
Secondary	Gestational Age of Neonates/Infants		Up to approximately 9 months after enrollment
Secondary	Apgar Score of Neonates/Infants		Delivery (up to approximately 9 months after enrollment) to 18 months
Secondary	Number of Infant Illnesses or Infections		Delivery (up to approximately 9 months after enrollment) to 18 months
Secondary	Neonatal Platelet Count		Delivery (up to approximately 9 months after enrollment) to 18 months
Secondary	Weight of Neonates/Infants		At Delivery (up to approximately 9 months after enrollment)
Secondary	Length of Neonates/Infants		At Delivery (up to approximately 9 months after enrollment)
Secondary	Head Circumference of Neonates/Infants		At Delivery (up to approximately 9 months after enrollment)