Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-29 @ 9:21 PM
Study NCT ID:
NCT00373061
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2006-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of the Use and Safety of Xolair® During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069444', 'term': 'Omalizumab'}], 'ancestors': [{'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 309}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-12', 'studyFirstSubmitDate': '2006-09-05', 'studyFirstSubmitQcDate': '2006-09-05', 'lastUpdatePostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Live Births', 'timeFrame': 'At Delivery (up to approximately 9 months after enrollment)'}, {'measure': 'Number of Elective Terminations', 'timeFrame': 'At Delivery (up to approximately 9 months after enrollment)'}, {'measure': 'Number of Fetal Deaths or Stillbirths', 'timeFrame': 'At Delivery (up to approximately 9 months after enrollment)'}, {'measure': 'Number of Congenital Birth Anomalies', 'timeFrame': 'At Delivery (up to approximately 9 months after enrollment)'}], 'secondaryOutcomes': [{'measure': 'Number of Spontaneous Abortions', 'timeFrame': 'At Delivery (up to approximately 9 months after enrollment)'}, {'measure': 'Number of Pregnancy Complications or Abnormalities', 'timeFrame': 'Up to approximately 9 months after enrollment'}, {'measure': 'Number of Delivery Complications or Abnormalities', 'timeFrame': 'At Delivery (up to approximately 9 months after enrollment)'}, {'measure': 'Gestational Age of Neonates/Infants', 'timeFrame': 'Up to approximately 9 months after enrollment'}, {'measure': 'Apgar Score of Neonates/Infants', 'timeFrame': 'Delivery (up to approximately 9 months after enrollment) to 18 months'}, {'measure': 'Number of Infant Illnesses or Infections', 'timeFrame': 'Delivery (up to approximately 9 months after enrollment) to 18 months'}, {'measure': 'Neonatal Platelet Count', 'timeFrame': 'Delivery (up to approximately 9 months after enrollment) to 18 months'}, {'measure': 'Weight of Neonates/Infants', 'timeFrame': 'At Delivery (up to approximately 9 months after enrollment)'}, {'measure': 'Length of Neonates/Infants', 'timeFrame': 'At Delivery (up to approximately 9 months after enrollment)'}, {'measure': 'Head Circumference of Neonates/Infants', 'timeFrame': 'At Delivery (up to approximately 9 months after enrollment)'}]}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 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\n\nExclusion Criteria:\n\n* Women not currently pregnant\n* Women exposed to Xolair® not during pregnancy but only while breastfeeding\n* Re-enrollment of women who are pregnant for second (or more) time is not allowed'}, 'identificationModule': {'nctId': 'NCT00373061', 'acronym': 'EXPECT', 'briefTitle': 'An Observational Study of the Use and Safety of Xolair® During Pregnancy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'The Xolair® Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy', 'orgStudyIdInfo': {'id': 'Q2952g'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant Women Exposed to Xolair®', 'description': '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.', 'interventionNames': ['Drug: Xolair®']}], 'interventions': [{'name': 'Xolair®', 'type': 'DRUG', 'otherNames': ['Omalizumab'], 'description': 'This being an observational study, the study protocol does not specify any dose regimen.', 'armGroupLabels': ['Pregnant Women Exposed to Xolair®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27560-7200', 'city': 'Morrisville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Ppd Development, Llc', 'geoPoint': {'lat': 35.82348, 'lon': -78.82556}}], 'overallOfficials': [{'name': 'Clinical Trials Hoffmann-La Roche', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}