Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-02-10 @ 10:40 PM
Study NCT ID:
NCT01810835
Status:
COMPLETED
Last Update Posted:
2013-12-06
First Post:
2013-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Hepatitis B Virus Mother-to-child Transmission by Serovaccination.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-05', 'studyFirstSubmitDate': '2013-03-12', 'studyFirstSubmitQcDate': '2013-03-13', 'lastUpdatePostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of HBsAg positivity in infants at 9 months, despite a correct immunization at birth', 'timeFrame': '9 months of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HBV mother-to-child transmission', 'women with HBV DNA > 105 I.U./mL', 'France'], 'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The prevalence of HBsAg carriage in pregnant women varies in France, according to the native country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 % in Parisian area). The level of HBV-DNA varies according to HBe status and geographical origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). It has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 % in newborns to mothers whom HBV-DNA was \\< 105 copies/mL and up to more than 40 % in newborns to mothers with high viral loads \\> 108 copies/mL, despite HBIg and vaccine at birth. Thus, data are needed concerning the current practices about the prevention of HBV MTCT in France, and their results.', 'detailedDescription': 'This monocentre, observational study will include pregnant women whom HBV-DNA is \\> 105 IU/mL. HBV MTCT rates will be evaluated, according to the level of HBV-DNA in the women during the last three months of pregnancy and at childbirth (between 105 and 108 IU/mL, or \\> 108 IU/mL), and according to the clinical practices of serovaccination in the participating center. The evaluation will be based on the rate of HBsAg positivity in infants at 9 months, despite a correct immunization at birth. The rate of detectable HBV-DNA will be also evaluated in infants at the same date.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This monocentre, observational study will include pregnant women whom HBV-DNA is \\> 105 IU/mL and who are not currently treated for HBV hepatitis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant woman\n* whom HBs Ag +\n* whom HBV-DNA \\>105 IU/mL\n\nExclusion Criteria:\n\n* Women who have to be treated for HBV hepatitis, (AST/ALT \\>2 ULN without any explanation, liver biopsy performed before pregnancy showing hepatitis requiring initiation of treatment)'}, 'identificationModule': {'nctId': 'NCT01810835', 'briefTitle': 'Prevention of Hepatitis B Virus Mother-to-child Transmission by Serovaccination.', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Lariboisière'}, 'officialTitle': 'Prevention of Hepatitis B Virus (HBV) Mother-to-child Transmission (MTCT): Impact of Serovaccination in Lariboisiere Hospital, Paris, France.', 'orgStudyIdInfo': {'id': 'URT-Liver-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Lariboisiere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Pierre O Sellier, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Lariboisiere, Paris, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Lariboisière', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Medicine A Department', 'investigatorFullName': 'Stephane Mouly, MD PhD', 'investigatorAffiliation': 'Hopital Lariboisière'}}}}