Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 7:04 AM
Study NCT ID:
NCT04805034
Status:
UNKNOWN
Last Update Posted:
2021-08-23
First Post:
2021-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Model for Prognosis of Chronic HBV Infection Mothers
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': 'D000375', 'term': 'Aging'}], 'ancestors': [{'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-20', 'studyFirstSubmitDate': '2021-03-17', 'studyFirstSubmitQcDate': '2021-03-17', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of HBeAg loss', 'timeFrame': 'Postpartum 96weeks'}, {'measure': 'the rate of HBeAg seroconversion', 'timeFrame': 'Postpartum 96weeks'}, {'measure': 'the rate of HBsAg loss', 'timeFrame': 'Postpartum 96weeks'}], 'secondaryOutcomes': [{'measure': 'the rate of undetectable HBV DNA', 'timeFrame': 'Postpartum 96weeks'}, {'measure': 'the rate ALT normalization', 'timeFrame': 'Postpartum 96weeks'}, {'measure': 'Dynamic changes of serum HBsAg, HBeAg, HBV DNA and HBV RNA titer', 'timeFrame': 'at delivery, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks after delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'Pregnancy is a complex and coordinated physiological process. Pregnancy and the postpartum period are associated with unique changes in the immune system that may impact the natural history of autoimmune diseases and immune-mediated infections. In the postpartum period. ALT flares have been reported in 20%-60% of untreated women and were more likely to occur in hepatitis B e antigen (HBeAg)-positive patients. It has been postulated that postpartum ALT flares may arise to rapid immune restitution against hepatitis B virus (HBV) antigens in the liver, when may be a timing of antiviral treatment. A large number of previous studies have focused on studies on the interruption of mother-to-child transmission in women with chronic hepatitis B(CHB), but studies on the prognosis of mothers undergoing pregnancy and delivery are very limited. What are the factors that affect the clearance of HBeAg or HBsAg? What kind of antiviral treatment protocol should be adopted for mothers with CHB? It is not only a problem that needs to be solved urgently in clinical practice, but also can provide some clues for understanding the occurrence and development of HBV infection in women of childbearing age.\n\nOverall, this study intends to carry out a multi-center two-way cohort study on E antigen-positive CHB women in 9 hospitals in Shaanxi Province. To observe the dynamic changes of virological parameters in these patients, figure out the factors of the serum HBsAg loss and HBeAg seroconversion, and establish relevant predictive models.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Mothers with chronic hepatitis B infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-45 years old\n* Serum HBsAg positive\\> 6 months\n* HBeAg positive at delivery\n* Good compliance\n\nExclusion Criteria:\n\n* Women who give birth to stillbirth due to various reasons\n* Coinfection with HIV,HCV, syphilis or other sexually transmitted diseases\n* Severe kidney, cardiovascular, lung, nervous system or immune system diseases\n* Who are taking immunotherapy drugs or anti-tumor drugs'}, 'identificationModule': {'nctId': 'NCT04805034', 'acronym': 'PMFPOEPMWCHI', 'briefTitle': 'Predictive Model for Prognosis of Chronic HBV Infection Mothers', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Predictive Model for Prognosis of E Antigen-positive Mothers With Chronic HBV Infection: A Multicenter Cohort Study', 'orgStudyIdInfo': {'id': 'XJTU1AF-CRF-2020-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HBeAg positive/HBsAg positive', 'interventionNames': ['Other: Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level']}, {'label': 'HBeAg seroconversion /HBsAg loss', 'interventionNames': ['Other: Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level']}], 'interventions': [{'name': 'Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level', 'type': 'OTHER', 'description': 'Exposure factors: Age, BMI, Family history, Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level', 'armGroupLabels': ['HBeAg positive/HBsAg positive', 'HBeAg seroconversion /HBsAg loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tianyan Chen', 'role': 'CONTACT', 'email': 'chentianyan@126.com', 'phone': '0086-18991232530'}], 'facility': "First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Tianyan Chen, phD', 'role': 'CONTACT', 'email': 'chentianyan@126.com', 'phone': '0086-18991232530'}, {'name': 'Naijuan Yao, phD', 'role': 'CONTACT', 'email': '897402048@qq.com', 'phone': '0086-13186036653'}], 'overallOfficials': [{'name': 'Tianyan Chen, phD', 'role': 'STUDY_CHAIR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'collaborators': [{'name': 'the Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine', 'class': 'UNKNOWN'}, {'name': "Northwest Women's and Children's Hospital, Xi'an, Shaanxi", 'class': 'OTHER'}, {'name': "Shaanxi Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Baoji Maternal and Child Health Hospital', 'class': 'UNKNOWN'}, {'name': 'Weinan Central Hospital', 'class': 'OTHER'}, {'name': 'Ankang Central Hospital', 'class': 'OTHER'}, {'name': 'Hanzhong Central Hospital', 'class': 'OTHER'}, {'name': "Yan'an University Affiliated Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}