Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT01362660
Status:
COMPLETED
Last Update Posted:
2013-02-06
First Post:
2011-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-05', 'studyFirstSubmitDate': '2011-05-24', 'studyFirstSubmitQcDate': '2011-05-26', 'lastUpdatePostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bayley Infant Neurodevelopmental Screener', 'timeFrame': '0-2 Months'}, {'measure': 'Bayley Infant Neurodevelopmental Screener', 'timeFrame': '8 months'}, {'measure': 'Bayley Infant Neurodevelopmental Screener', 'timeFrame': '15 months'}, {'measure': 'Receptive-Expressive Emergent Language Test', 'timeFrame': '0-2 Months'}, {'measure': 'Receptive-Expressive Emergent Language Test', 'timeFrame': '8 months'}, {'measure': 'Receptive-Expressive Emergent Language Test', 'timeFrame': '15 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['post-natal monitoring', 'exposure in utero'], 'conditions': ['Infant Developmental Assessment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091055&StudyName=A%20Study%20to%20Evaluate%20Infants%20with%20Potential%20Exposure%20to%20Tanezumab%20Before%20Birth%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).', 'detailedDescription': 'This study will enroll infants with potential tanezumab exposure in utero at sites overseen by Schulman and Associates IRB This study will attempt to enroll all infants who qualify.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants with potential exposure in utero through their parents partcipation in a tanezumab clinical study', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study through direct maternal exposure; or is an infant born to a mother who is a partner of a male patient who was exposed to study drug in a tanezumab clinical study prior to or around the time of conception and/or is exposed during his partner's pregnancy.\n\nExclusion Criteria:\n\nThere are no exclusion criteria for this study"}, 'identificationModule': {'nctId': 'NCT01362660', 'briefTitle': 'A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Protocol to Monitor the Neurological Development of Infants With Exposure In-utero From Birth to Aged 15 Months in Tanezumab Clinical Studies at Investigational Sites Overseen by Schulman and Associates Institutional Review Board', 'orgStudyIdInfo': {'id': 'A4091055'}, 'secondaryIdInfos': [{'id': 'NEONATAL MONITORING'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infants with potential exposure in utero', 'interventionNames': ['Other: Unintentional exposure in utero']}], 'interventions': [{'name': 'Unintentional exposure in utero', 'type': 'OTHER', 'description': 'This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).', 'armGroupLabels': ['Infants with potential exposure in utero']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '92595', 'city': 'Wildomar', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.59891, 'lon': -117.28004}}, {'zip': '33189', 'city': 'Cutler Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.5783, 'lon': -80.3377}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '38119-5214', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77065', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}