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

NCT ID: NCT00373061

Last Updated: 2018-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

309 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-20

Study Completion Date

2018-01-05

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant Women Exposed to Xolair®

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.

Xolair®

Intervention Type DRUG

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

Interventions

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Xolair®

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

Intervention Type DRUG

Other Intervention Names

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Omalizumab

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials Hoffmann-La Roche

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Ppd Development, Llc

Morrisville, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Q2952g

Identifier Type: -

Identifier Source: org_study_id

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