Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT02799316
Status:
UNKNOWN
Last Update Posted:
2017-06-20
First Post:
2016-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test Before Immunosuppressive Therapies?
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-17', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2016-06-10', 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with occult HBV.', 'timeFrame': '1 year', 'description': 'Number of patients having occult HBV.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': 'Hepatitis B virus (HBV) infection is a challenging health problem. According to the World Health Organization, an estimated 240 million individuals (3.7%) suffered from chronic HBV infection worldwide.\n\nAfter acute hepatitis B virus (HBV) infection, the disappearance of hepatitis B surface antigen (HBsAg) had generally been believed to signify viral elimination. However, it now becomes clear that those subjects may have occult HBV infection which is defined as the presence of HBV DNA in the liver in the absence of HBsAg in the serum. Occult HBV infection usually accompanies antibody against hepatitis B core antigen (anti-HBc) and/or antibody against HBsAg (anti-HBs), but some cases might not have these serological markers (seronegative occult HBV infection) .', 'detailedDescription': 'In a recent systematic review, nearly 40% of HBsAg carriers and 5% of antiHBc-positive but HBsAg-negative patients developed HBVr during TNF inhibitor therapy.\n\nConsidering the lifelong use of multiple antirheumatic drugs, we need more specific guidelines for the management of rheumatic disease patients who are scheduled to receive biological and/or non-biological DMARDs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Any patients with rheumatic disease with hepatitis B surface antigen negative.\n\nExclusion Criteria:\n\n* • Overt co-morbid condition.\n\n * Any malignancy e.g. HCC'}, 'identificationModule': {'nctId': 'NCT02799316', 'briefTitle': 'Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test Before Immunosuppressive Therapies?', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test for Hepatitis B Virus Infection in Rheumatic Disease Patients Before Starting Immunosuppressive Therapies??', 'orgStudyIdInfo': {'id': 'Rasha Abdelno'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'rheumatic disease with HBs-ag positive', 'description': '• HBV core antibodies testing. • Real time PCR testing.', 'interventionNames': ['Other: HBV core antibodies testing. • Real time PCR testing.']}], 'interventions': [{'name': 'HBV core antibodies testing. • Real time PCR testing.', 'type': 'OTHER', 'description': '* HBV core antibodies testing in HBV surface antigen negative patients.\n* Real time PCR testing for those having positive HBc antibodies.', 'armGroupLabels': ['rheumatic disease with HBs-ag positive']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherief Abd-elsalam, lecturer', 'role': 'CONTACT', 'email': 'Sherif_tropical@yahoo.com', 'phone': '00201000040794'}], 'facility': 'Sherief Abd-Elsalam', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sherief Abd-Elsalam, Consultant', 'role': 'CONTACT', 'email': 'sherif_tropical@yahoo.com', 'phone': '00201095159522'}], 'overallOfficials': [{'name': 'Rasha A Abdel Noor, Consultant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Internal medicine department - Tanta university'}, {'name': 'Sherief Abd-Elsalam, Consultant', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Gastroenterology and Hepatology- Tanta'}, {'name': 'Walaa Elkhalawany, Consultant', 'role': 'STUDY_CHAIR', 'affiliation': 'liver diseases dept.-Tanta university hospital'}, {'name': 'Mona Watani, Consultant', 'role': 'STUDY_CHAIR', 'affiliation': 'liver diseases dept.-Tanta university hospital'}, {'name': 'Rehab Badawi, Consultant', 'role': 'STUDY_CHAIR', 'affiliation': 'liver diseases dept.-Tanta university hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherief Abd-Elsalam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant liver and GIT diseases- Tanta university hospital', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}