Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-25 @ 12:28 AM
Study NCT ID:
NCT02863757
Status:
RECRUITING
Last Update Posted:
2025-03-24
First Post:
2016-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], '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'}, {'id': 'D005234', 'term': 'Fatty Liver'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2016-08-08', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma', 'timeFrame': 'Up to 20 years'}], 'secondaryOutcomes': [{'measure': 'Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia', 'timeFrame': 'Up to 20 years'}, {'measure': 'Number of patients with liver transplantation and liver-related death', 'timeFrame': 'Up to 20 years'}, {'measure': 'Diagnosis time of liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma from baseline', 'timeFrame': 'Up to 20 years'}, {'measure': 'Occurrence time of liver transplantation and liver-related death from baseline', 'timeFrame': 'Up to 20 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B', 'Nonalcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the disease progression in CHB/NAFLD compared with CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma (HCC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hosptials and primary care clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver biopsy proved CHB and/or NAFLD at baseline;\n* Chinese\n* Follow-up duration\\>12 months\n\nExclusion Criteria:\n\n* Other liver diseases;\n* Secondary causes of hepatic steatosis;\n* Alcohol abuse;\n* Liver cirrhosis, cirrhosis related complications or HCC at baseline;\n* Malignancy;\n* History of liver transplantation'}, 'identificationModule': {'nctId': 'NCT02863757', 'briefTitle': 'Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Humanity and Health Research Centre'}, 'officialTitle': 'Disease Progression and Clinical Outcomes in Chronic Hepatitis B (CHB) Patients With Comorbid Nonalcoholic Fatty Liver Disease (NAFLD)', 'orgStudyIdInfo': {'id': 'H&H_NAFLD/CHB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CHB Group', 'description': 'Patients with chronic hepatitis B'}, {'label': 'CHB/NAFLD Group', 'description': 'Patients with chronic hepatitis B and comorbid nonalcoholic fatty liver disease'}, {'label': 'NAFLD Group', 'description': 'Patients with nonalcoholic fatty liver disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00852', 'city': 'Hong Kong', 'state': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'George KK Lau, MD', 'role': 'CONTACT', 'email': 'gkklau@netvigator.com', 'phone': '(852)28613777'}, {'name': 'George KK Lau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Humanity and Health GI and Liver Centre', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'George Lau, MD', 'role': 'CONTACT', 'email': 'gkklau@netvigator.com', 'phone': '+852 2861 3777'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanity and Health Research Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}