Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-05 @ 6:09 PM
Study NCT ID:
NCT00939068
Status:
UNKNOWN
Last Update Posted:
2009-10-14
First Post:
2009-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077712', 'term': 'Telbivudine'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-10-13', 'studyFirstSubmitDate': '2009-07-13', 'studyFirstSubmitQcDate': '2009-07-13', 'lastUpdatePostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery)', 'timeFrame': '1 month post partum'}], 'secondaryOutcomes': [{'measure': 'liver function normalization rate; HBV DNA and HBeAg reduction and negative conversion rate;', 'timeFrame': '1 month post partum'}, {'measure': 'drug adverse reaction in pregnant women; complications during pregnancy and delivery, gestational age at delivery, the method of delivery, peripartum hemorrhage, the newborn growth and development milestones, Apgar score, newborn deformity prevalence', 'timeFrame': '.1 year after childbirth'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic hepatitis B, Telbivudine, Intrauterine transmission'], 'conditions': ['Chronic Hepatitis B, Gestation']}, 'referencesModule': {'references': [{'pmid': '28039902', 'type': 'DERIVED', 'citation': 'Han GR, Jiang HX, Wang CM, Ding Y, Wang GJ, Yue X, Zhou L, Zhao W. Long-term safety and efficacy of telbivudine in infants born to mothers treated during the second or third trimesters of pregnancy. J Viral Hepat. 2017 Jun;24(6):514-521. doi: 10.1111/jvh.12670. Epub 2017 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.', 'detailedDescription': 'In the present study, we evaluated the effect of telbivudine given during the second and third trimesters of pregnancy to highly viremic, HBV DNA-positive mothers on maternal HBV DNA and HBeAg levels prior to delivery and the rate of vertical transmission of HBV to infants who received passive-active immunoprophylaxis. Additionally, we investigated the timing of the administration of telbivudine on reducing the risk of perinatal transmission and the safety of telbivudine during pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-40 years old pregnant woman with gestational age of 20-32 week;\n* positive serum HBsAg;\n* HBV DNA≥1.0x106 copies/ml;\n\nExclusion Criteria:\n\n* with previous antiviral treatment;\n* with clinical sign of threatened miscarriage or related treatment in early pregnancy;\n* positive serum HAV, HCV, HDV and HEV tests;\n* fetus deformity by 3-D ultrasound examination;\n* on other dugs, such as immune modulators, cytotoxic drugs or steroids;\n* husbands are infected with HBV.'}, 'identificationModule': {'nctId': 'NCT00939068', 'briefTitle': 'Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'A Study of Efficacy and Safety of Telbivudine in Pregnancy for the Prevention of Perinatal Transmission of Hepatitis B Virus Infection', 'orgStudyIdInfo': {'id': 'H200804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telbivudine', 'description': 'Drug administration and follow up: the subjects in Telbivudine group start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continue to one month after delivery.And their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.', 'interventionNames': ['Drug: Telbivudine']}, {'type': 'OTHER', 'label': 'Control', 'description': 'The pregnant subjects in Control group are intervented with no drugs, but their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.', 'interventionNames': ['Biological: engineered HB vaccine']}], 'interventions': [{'name': 'Telbivudine', 'type': 'DRUG', 'otherNames': ['telbivudine treatment'], 'description': 'Subjects start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continued to one month after delivery.', 'armGroupLabels': ['Telbivudine']}, {'name': 'engineered HB vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['control group'], 'description': 'All the newborns in control group are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20 ug respectively at age of 0, 1 and 6 months.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wei Zhao, P.H.D', 'role': 'STUDY_CHAIR', 'affiliation': 'the Second Affiliated Hospital of Southeast University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Wei Zhao', 'oldOrganization': 'the Second Hospital of Nanjing, China'}}}}