Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-30 @ 2:54 AM
Study NCT ID:
NCT02301650
Status:
UNKNOWN
Last Update Posted:
2014-11-26
First Post:
2014-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Anti-viral Drugs Used in Late Pregnancy on Long-term Development of Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006356', 'term': 'Heartburn'}], '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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'D000077712', 'term': 'Telbivudine'}, {'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'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': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-22', 'studyFirstSubmitDate': '2014-11-12', 'studyFirstSubmitQcDate': '2014-11-22', 'lastUpdatePostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of abnormal development', 'timeFrame': '6 months', 'description': "The children' development will be measured by Gesell Developmental Scales, including adaptability, mobility, fine motion skills, language ability and social skills.The children will be considered normal if the score is ≥86, score between 76-85 is suspicious, and score≤75 is abnormal."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis B virus', 'pregnancy', 'nucleoside (acid) analogs', 'children', 'safety'], 'conditions': ['the Safety of Anti-viral Drugs Used in Late Pregnancy']}, 'descriptionModule': {'briefSummary': "Mother to child transmission(MTCT) is the main route of hepatitis B virus(HBV) transmission.High HBV DNA level of pregnant women is the main risk factor of MTCT. Many literatures demonstrate that using nucleoside (acid) analogs in late pregnancy can significantly reduce HBV DNA level and effectively blocking MTCT. Therefore, treatment guidelines of hepatitis B in Europe and the Asia Pacific region clearly pointed out: Nucleoside (acid) analogs can be used in pregnant women after 28 weeks of gestation for blocking MTCT in mothers with high HBV DNA level. At present, the drugs used in late pregnancy including lamivudine (LAM) ,telbivudine(LdT) and tenofovir(TDF).\n\nThe safety of nucleoside (acid) analogues used in late pregnancy on children is not clear.In most of the related researches,the observation termination was 7-12 months after birth, and most were concentrated on the blocking effect of MTCT.The long-term impact of Nucleoside (acid) analogues on children's development has not been reported in the literatures. The aim of this study is to make clear of the effect of nucleoside (acid) analogues used in late pregnancy on long-term impact of children's development.\n\nThe one year old children born in Beijing Ditan hospital and whose mothers had taken LAM,LdT or TDF during late pregnancy will be enrolled as study group, and eligible children whose mothers untreated will be enrolled as control group. The children's height, weight, nutritional status, developmental quotient and immune response to hepatitis B vaccine etc will be evaluated at baseline and at 3 years old. By comparing the children's development in different groups as well as in self-control of different ages, we will discuss the effect of Nucleoside (acid) analogues on children's long-term development."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The one year old children born in BeiJing DiTan Hospital and whose mothers had taken Lamivudine, Telbivudine or Tenofovir and untreated in late pregnancy with HBV DNA level over 6.0 log10 IU/ml', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The one year old children whose mothers had taken Lamivudine,Telbivudine or Tenofovir in late pregnancy(28-30 weeks of gestation);\n* The one year old children whose mothers untreated in late pregnancy;\n* Children had completed standard hepatitis B vaccine and hepatitis B immune globulin combined active and passive prophylaxis;\n* HBV DNA level of the children's mothers were over 6.0 log10 IU/ml before 28 weeks of gestation.\n\nExclusion Criteria:\n\n* Children whose mothers over 35 years old at delivery;\n* The couple having family hereditary disease or abnormal malformation has been found at fetal screening before 28 weeks gestation;\n* History of amniocentesis during pregnancy;\n* Co-infection with either hepatitis C virus, hepatitis D virus, human immunodeficiency virus, syphilis, toxoplasmosis, rubella or cytomegalovirus.\n* Complications of pregnancy-induced hypertension, premature rupture of membranes, preterm birth, placenta previa or placental abruption; asphyxia at birth."}, 'identificationModule': {'nctId': 'NCT02301650', 'briefTitle': 'The Effect of Anti-viral Drugs Used in Late Pregnancy on Long-term Development of Children', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Ditan Hospital'}, 'officialTitle': 'The Effect of Anti-viral Drugs Used in Late Pregnancy in Mothers With Hepatitis B Virus Infection on Long-term Development of Children', 'orgStudyIdInfo': {'id': 'Z141107002514131'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group A', 'description': 'The one year old children born in Beijing Ditan hospital and whose mothers had taken Lamivudine in late pregnancy', 'interventionNames': ['Drug: Lamivudine']}, {'label': 'group B', 'description': 'The one year old children born in Beijing Ditan hospital and whose mothers had taken Telbivudine in late pregnancy', 'interventionNames': ['Drug: Telbivudine']}, {'label': 'group C', 'description': 'The one year old children born in Beijing Ditan hospital and whose mothers had taken Tenofovir in late pregnancy', 'interventionNames': ['Drug: Tenofovir']}, {'label': 'group D', 'description': 'The one year old children born in Beijing Ditan hospital and whose mothers untreated in late pregnancy'}], 'interventions': [{'name': 'Lamivudine', 'type': 'DRUG', 'otherNames': ['3-TC', 'CAS: 134678-17-4'], 'description': 'mothers use Lamivudine in late pregnancy', 'armGroupLabels': ['group A']}, {'name': 'Telbivudine', 'type': 'DRUG', 'otherNames': ['CAS: 3424-98-4'], 'description': 'mothers use Telbivudine in late pregnancy', 'armGroupLabels': ['group B']}, {'name': 'Tenofovir', 'type': 'DRUG', 'otherNames': ['Tenofovir Disoprox', 'CAS: 147127-20-6'], 'description': 'mothers use Tenofovir in late pregnancy', 'armGroupLabels': ['group C']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wei Yi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Ditan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Wei Yi', 'investigatorAffiliation': 'Beijing Ditan Hospital'}}}}