Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-02-18 @ 3:06 AM
Study NCT ID:
NCT02128503
Status:
TERMINATED
Last Update Posted:
2017-04-25
First Post:
2014-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Clinical Course of Chronic Hep B Infection in IBD and Rheumatologic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 430}}, 'statusModule': {'whyStopped': 'sample size recruited is not enough', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-23', 'studyFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2014-04-29', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in HBV DNA levels', 'timeFrame': '2 Years', 'description': 'Changes in HBV DNA levels in patients with chronic hepatitis B and IBD treated with immunosuppressants'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Disease', 'Crohn Disease', 'Ulcerative Colitis', 'Rheumatic Diseases', 'Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the prevalence of HBV infection in patients with IBD and rheumatologic disease, and to assess the impact of immunosuppressive therapy on viral load and clinical course of IBD patients.', 'detailedDescription': 'The incidence of inflammatory bowel disease (IBD) has been increasing in Hong Kong. The management of inflammatory bowel disease involved the use of immunosuppressant, however, the use of immunosuppressant in patients with hepatitis B infection has been associated with hepatitis B reactivation. It is estimated that around 7% of the Hong Kong population is infected with HBV. The information on the prevalence of hepatitis B in IBD patients in Hong Kong is lacking. Moreover, limited information is available on the effect of different immunosuppressive regimens given for longer periods of time in lower doses in patients with chronic HBV infection and IBD. There is therefore a need to determine the incidence and predictive factors for HBV reactivation in these patients.\n\nRheumatologic diseases, including systemic lupus erythematous, rheumatoid arthritis, psoriasis and anklyosing spondylitis are inflammatory conditions which commonly affect the locomotors system as well as other organs. Epidemiological data from China have suggested that patients with ankylosing spondylitis have a higher risk of hepatitis B infection; while the rates of hepatitis B for those with rheumatoid arthritis, and other spondyloathropathies are similar to that of the general population. However, there are no such local data in Hong Kong aspect.\n\nThis study aims to determine the prevalence of HBV infection in patients with IBD and rheumatologic disease, and to assess the impact of immunosuppressive therapy on viral load and clinical course of IBD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All IBD and rheumatologic patients aged 18 years or older\n\nExclusion Criteria:\n\n* Lack of consent\n* Patients with evidence of other chronic liver disease,metabolic syndrome, men consuming more than 30 g of alcohol per day and women consuming more than 20 g of alcohol per day, patients with liver decompensation, HCC, previous liver surgery or liver transplantation'}, 'identificationModule': {'nctId': 'NCT02128503', 'briefTitle': 'Prevalence and Clinical Course of Chronic Hep B Infection in IBD and Rheumatologic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Prevalence and Clinical Course of Chronic Hepatitis B Infection in Patients With Inflammatory Bowel Disease and Rheumatologic Disease on Immunosuppressive Therapy', 'orgStudyIdInfo': {'id': 'IBD-RA HBV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HBV DNA level monitoring', 'description': 'Group with HBV DNV level being monitored regularly', 'interventionNames': ['Other: HBV DNA level monitoring']}], 'interventions': [{'name': 'HBV DNA level monitoring', 'type': 'OTHER', 'description': 'HBV DNV level being monitoring regularly', 'armGroupLabels': ['HBV DNA level monitoring']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Siew Chien Ng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Siew Chien NG', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}