Overview

This trial is active, not recruiting.

Condition asthma
Phase phase 4
Sponsor Genentech, Inc.
Start date October 2006
End date August 2017
Trial size 304 participants
Trial identifier NCT00373061, Q2952g

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 infants are 12 months old.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

Female participants of any age.

Eligibility for enrollment is based on Xolair exposure in women, whether inadvertent or deliberate, in relation to pregnancy. Women who have been exposed to at least one dose of Xolair within 8 weeks prior to conception or during pregnancy may be included in this registry.

Additional Information

Official title The Xolair Pregnancy Registry: An Observational Study of the Use and Safety of Xolair (Omalizumab) During Pregnancy
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Genentech, Inc..