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

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.
 
ClinicalTrials.gov Identifier: NCT00373061
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date September 5, 2006
First Posted Date September 7, 2006
Last Update Posted Date February 14, 2018
Actual Study Start Date October 20, 2006
Actual Primary Completion Date December 11, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 3, 2017)
  • 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) ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00373061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 3, 2017)
  • 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) ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of the Use and Safety of Xolair® During Pregnancy
Official Title The Xolair® Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Asthma
Intervention Drug: Xolair®
This being an observational study, the study protocol does not specify any dose regimen.
Other Name: Omalizumab
Study Groups/Cohorts 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.
Intervention: Drug: Xolair®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 3, 2017)
309
Original Enrollment
 (submitted: September 5, 2006)
250
Actual Study Completion Date January 5, 2018
Actual Primary Completion Date December 11, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00373061
Other Study ID Numbers Q2952g
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Genentech, Inc.
Study Sponsor Genentech, Inc.
Collaborators Novartis
Investigators
Study Director: Clinical Trials Hoffmann-La Roche Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date February 2018