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

NCT00373061 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 309

Last updated 2018-02-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Xolair®

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials Hoffmann-La Roche · Hoffmann-La Roche

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-20
Primary Completion
2017-12-11
Completion
2018-01-05

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00373061 on ClinicalTrials.gov