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OpenTrials
Completed

NCT Number: NCT00373061

An Observational Study of the Use and Safety of Xolair® 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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Ppd Development, Llc

Morrisville, North Carolina, 27560-7200, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xolair®

Drug

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

Other names: Omalizumab

Primary outcomes

  1. Number of Live Births

    Time frame: At Delivery (up to approximately 9 months after enrollment)

  2. Number of Elective Terminations

    Time frame: At Delivery (up to approximately 9 months after enrollment)

  3. Number of Fetal Deaths or Stillbirths

    Time frame: At Delivery (up to approximately 9 months after enrollment)

  4. Number of Congenital Birth Anomalies

    Time frame: At Delivery (up to approximately 9 months after enrollment)

Secondary outcomes

  1. Number of Spontaneous Abortions

    Time frame: At Delivery (up to approximately 9 months after enrollment)

  2. Number of Pregnancy Complications or Abnormalities

    Time frame: Up to approximately 9 months after enrollment

  3. Number of Delivery Complications or Abnormalities

    Time frame: At Delivery (up to approximately 9 months after enrollment)

  4. Gestational Age of Neonates/Infants

    Time frame: Up to approximately 9 months after enrollment

  5. Apgar Score of Neonates/Infants

    Time frame: Delivery (up to approximately 9 months after enrollment) to 18 months

  6. Number of Infant Illnesses or Infections

    Time frame: Delivery (up to approximately 9 months after enrollment) to 18 months

  7. Neonatal Platelet Count

    Time frame: Delivery (up to approximately 9 months after enrollment) to 18 months

  8. Weight of Neonates/Infants

    Time frame: At Delivery (up to approximately 9 months after enrollment)

  9. Length of Neonates/Infants

    Time frame: At Delivery (up to approximately 9 months after enrollment)

  10. Head Circumference of Neonates/Infants

    Time frame: At Delivery (up to approximately 9 months after enrollment)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Collaborators

  • Novartis

Registry information

Official study title

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

Acronym: EXPECT

Important dates

Study start
2006
Primary completion
2017
Study completion
2018
First posted
Sep 7, 2006
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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