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

Completed

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00373061

Run by

Genentech, Inc.

People needed

309

Starts

2006-10-20

Expected to finish

2018-01-05

Last updated by the study team

2018-02-14

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ppd Development, Llc — Morrisville, North Carolina, United States

Full record on ClinicalTrials.gov

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