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

Genentech

Status: Completed

Conditions: Asthma

Treatments: Drug: Xolair®

Study type: Observational

Funder types: Industry

Identifiers

NCT00373061

Q2952g

Details and patient eligibility

About

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.

Enrollment: 309 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

309 participants in 1 patient group

Pregnant Women Exposed to Xolair®

Description:

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.

Treatment:

Drug: Xolair®