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

February 12, 2018 updated by: Genentech, Inc.

The Xolair® Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

309

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Morrisville, North Carolina, United States, 27560-7200
        • Ppd Development, Llc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women exposed to at least one dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy. Enrollment in the Xolair® Pregnancy Registry is voluntary and must be initiated by the pregnant woman. A healthcare provider cannot enroll a patient but can suggest that the pregnant woman call the Registry Center to enroll herself.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Xolair®
This being an observational study, the study protocol does not specify any dose regimen.
Other Names:
  • Omalizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Live Births
Time Frame: At Delivery (up to approximately 9 months after enrollment)
At Delivery (up to approximately 9 months after enrollment)
Number of Elective Terminations
Time Frame: At Delivery (up to approximately 9 months after enrollment)
At Delivery (up to approximately 9 months after enrollment)
Number of Fetal Deaths or Stillbirths
Time Frame: At Delivery (up to approximately 9 months after enrollment)
At Delivery (up to approximately 9 months after enrollment)
Number of Congenital Birth Anomalies
Time Frame: At Delivery (up to approximately 9 months after enrollment)
At Delivery (up to approximately 9 months after enrollment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Spontaneous Abortions
Time Frame: At Delivery (up to approximately 9 months after enrollment)
At Delivery (up to approximately 9 months after enrollment)
Number of Pregnancy Complications or Abnormalities
Time Frame: Up to approximately 9 months after enrollment
Up to approximately 9 months after enrollment
Number of Delivery Complications or Abnormalities
Time Frame: At Delivery (up to approximately 9 months after enrollment)
At Delivery (up to approximately 9 months after enrollment)
Gestational Age of Neonates/Infants
Time Frame: Up to approximately 9 months after enrollment
Up to approximately 9 months after enrollment
Apgar Score of Neonates/Infants
Time Frame: Delivery (up to approximately 9 months after enrollment) to 18 months
Delivery (up to approximately 9 months after enrollment) to 18 months
Number of Infant Illnesses or Infections
Time Frame: Delivery (up to approximately 9 months after enrollment) to 18 months
Delivery (up to approximately 9 months after enrollment) to 18 months
Neonatal Platelet Count
Time Frame: Delivery (up to approximately 9 months after enrollment) to 18 months
Delivery (up to approximately 9 months after enrollment) to 18 months
Weight of Neonates/Infants
Time Frame: At Delivery (up to approximately 9 months after enrollment)
At Delivery (up to approximately 9 months after enrollment)
Length of Neonates/Infants
Time Frame: At Delivery (up to approximately 9 months after enrollment)
At Delivery (up to approximately 9 months after enrollment)
Head Circumference of Neonates/Infants
Time Frame: At Delivery (up to approximately 9 months after enrollment)
At Delivery (up to approximately 9 months after enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Collaborators

Novartis

Investigators

  • Study Director: Clinical Trials Hoffmann-La Roche, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 20, 2006

Primary Completion (ACTUAL)

December 11, 2017

Study Completion (ACTUAL)

January 5, 2018

Study Registration Dates

First Submitted

September 5, 2006

First Submitted That Met QC Criteria

September 5, 2006

First Posted (ESTIMATE)

September 7, 2006

Study Record Updates

Last Update Posted (ACTUAL)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Q2952g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on Xolair®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe