Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-01 @ 9:40 PM
Study NCT ID:
NCT04135235
Status:
UNKNOWN
Last Update Posted:
2019-10-22
First Post:
2019-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-19', 'studyFirstSubmitDate': '2019-10-12', 'studyFirstSubmitQcDate': '2019-10-19', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the blocking successful rate of HBV mother-to-child transmission', 'timeFrame': '7 months after birth', 'description': 'HBV mother-to-child transmission blocking success rate (negative HBsAg and HBV DNA negative 7 months after birth)'}], 'secondaryOutcomes': [{'measure': 'The incidence of abnormal growth', 'timeFrame': 'at birth, at the 7 months after birth', 'description': 'The incidence of abnormal growth at birth'}, {'measure': 'The incidence of abnormal development', 'timeFrame': 'at birth, at the 7 months after birth', 'description': 'The incidence of abnormal development at birth'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Hepatitis B', 'Pregnant woman', 'High viral load', 'Tenofovir fumarate'], 'conditions': ['Chronic Hepatitis B Infection', 'High Viral Load']}, 'descriptionModule': {'briefSummary': 'This study is a prospective study. The subject will select 440 cases of pregnant women with high hepatitis B virus load, and one group will take maternal and child blockade treatment with propofol fumarate. One group will take tenofovir disoproxil fumarate. Broken treatment, compare the failure rate of maternal and child blockade and the incidence of maternal and child adverse events in the two groups, and explore the efficacy and safety of propofol flavuril for the treatment of hepatitis B mother-infant block.', 'detailedDescription': "This study was a prospective cohort study. Because propofolofofovir is not covered by medical insurance and is more expensive, and there are factors such as renal function damage and the risk factors that can not use tenofovir, it is difficult to conduct randomized controlled cases. The subject will select 440 cases of pregnant women with high hepatitis B virus load. After signing the informed consent form, according to the patient's wishes, one group will take the mother-infant blockade of propofol fumarate, and one group will take fumaric acid. In the case of maternal and child blockade of benifovir, the incidence of maternal and child block failure and the incidence of maternal and child adverse events were compared between the two groups, and propofol fumarate was used for maternal and child blockade of hepatitis B. The effectiveness and safety of the treatment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'High HBV viral load (HBV DNA ≥ 106 IU / mL) pregnant women with chronic HBV infection. All pregnant women with chronic HBV infection were in compliance with the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No nucleoside analog antiviral drugs have been used in the past.\n* HBsAg and HBeAg double positive, HBV DNA\\>106 IU/mL.\n* Fully inform the risk to voluntarily join the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Combine other viral infections: such as HCV, HIV, CMV, etc.;\n* amniocentesis during pregnancy;\n* Liver cirrhosis and liver cancer;\n* Other autoimmune diseases and liver diseases;\n* fetal ultrasound screening in early and middle pregnancy found deformity.'}, 'identificationModule': {'nctId': 'NCT04135235', 'briefTitle': 'Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Ditan Hospital'}, 'officialTitle': 'The Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B', 'orgStudyIdInfo': {'id': 'KY2019-08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAF group', 'description': 'take propofol fumarate for Maternal and child blockade treatment', 'interventionNames': ['Drug: TAF']}, {'label': 'TDF group', 'description': 'take difenofurate fumarate for Maternal and child blockade treatment', 'interventionNames': ['Drug: TDF']}], 'interventions': [{'name': 'TAF', 'type': 'DRUG', 'description': 'Propofol tenofovir fumarate', 'armGroupLabels': ['TAF group']}, {'name': 'TDF', 'type': 'DRUG', 'description': 'Dipirofurate fumarate tenofovir', 'armGroupLabels': ['TDF group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100015', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Yi', 'role': 'CONTACT', 'email': 'yiwei1215@163.com', 'phone': '13683687062'}, {'name': 'Yao Xie', 'role': 'CONTACT', 'email': 'xieyao00120184@sina.com', 'phone': '13501093293'}], 'facility': 'Beijing Ditan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wei Yi, Doctor', 'role': 'CONTACT', 'email': 'yiwei1215@163.com', 'phone': '13683687062'}, {'name': 'Yao Xie, Doctor', 'role': 'CONTACT', 'email': 'xieyao00120184@sina.com', 'phone': '13501093293'}], 'overallOfficials': [{'name': 'Wei Yi, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Ditan Hospital'}, {'name': 'Yao Xie, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Ditan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Obstetrics and Gynecology', 'investigatorFullName': 'Wei Yi', 'investigatorAffiliation': 'Beijing Ditan Hospital'}}}}