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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373061
First Posted: September 7, 2006
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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.

Condition Intervention
Asthma Drug: Xolair®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Xolair® Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Number of Live Births [ Time Frame: At Delivery (up to approximately 9 months after enrollment) ]
  • Number of Elective Terminations [ Time Frame: 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) ]
  • Number of Congenital Birth Anomalies [ Time Frame: At Delivery (up to approximately 9 months after enrollment) ]

Secondary Outcome Measures:
  • Number of Spontaneous Abortions [ Time Frame: At Delivery (up to approximately 9 months after enrollment) ]
  • Number of Pregnancy Complications or Abnormalities [ Time Frame: Up to approximately 9 months after enrollment ]
  • Number of Delivery Complications or Abnormalities [ Time Frame: At Delivery (up to approximately 9 months after enrollment) ]
  • Gestational Age of Neonates/Infants [ Time Frame: 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 ]
  • Number of Infant Illnesses or Infections [ Time Frame: 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 ]
  • Weight of Neonates/Infants [ Time Frame: At Delivery (up to approximately 9 months after enrollment) ]
  • Length of Neonates/Infants [ Time Frame: 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) ]

Enrollment: 309
Actual Study Start Date: October 20, 2006
Estimated Study Completion Date: January 5, 2018
Estimated Primary Completion Date: December 12, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Omalizumab

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373061


Locations
United States, North Carolina
Ppd Development, Llc
Morrisville, North Carolina, United States, 27560-7200
Sponsors and Collaborators
Genentech, Inc.
Novartis
Investigators
Study Director: Clinical Trials Hoffmann-La Roche Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00373061     History of Changes
Other Study ID Numbers: Q2952g
First Submitted: September 5, 2006
First Posted: September 7, 2006
Last Update Posted: October 5, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents