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

Genentech, Inc.309 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

309

Conditions

Asthma

Interventions

Xolair®DRUG

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

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

Ppd Development, Llc

Morrisville, North Carolina, United States