Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-01-03 @ 8:14 PM
Study NCT ID:
NCT02849132
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-04-28
First Post:
2016-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], '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'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C413685', 'term': 'entecavir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-25', 'studyFirstSubmitDate': '2016-07-22', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibrosis regression rate', 'timeFrame': 'year 3', 'description': 'Ishak fibrosis score decrease after long-term treatment'}, {'measure': 'Cumulative incidence of liver decompensation', 'timeFrame': 'year 8', 'description': 'Cumulative incidence of liver decompensation (including ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) and death after long-term treatment'}], 'secondaryOutcomes': [{'measure': 'Virological response', 'timeFrame': 'year 3, 5, 7 and 10', 'description': 'Percentage of patients achieving hepatitis B virus (HBV) DNA \\< 20IU/mL at year 3, 5, 7 and 10'}, {'measure': 'Aminotransferase response', 'timeFrame': 'year 3, 5, 7 and 10', 'description': 'The percentage of patients with alanine aminotransferase (ALT) normalization at year 3, 5, 7 and 10'}, {'measure': 'HBeAg loss or HBeAg seroconversion', 'timeFrame': 'year 2, 5, 7 and 10', 'description': 'Percentage of patients with HBeAg loss or HBeAg seroconversion at year 2, 5, 7 and 10'}, {'measure': 'HBsAg loss or HBsAg seroconversion rate', 'timeFrame': 'year 2, 5, 7 and 10', 'description': 'Percentage of patients with HBsAg loss or HBsAg seroconversion at year 2, 5, 7 and 10'}, {'measure': 'Dynamic changes of Child-Pugh score', 'timeFrame': 'year 3, 5, 7 and 10', 'description': 'Dynamic changes of Child-Pugh score after 3, 5, 7 and 10 years of treatment'}, {'measure': 'Dynamic changes of MELD score', 'timeFrame': 'year 3, 5, 7 and 10', 'description': 'Dynamic changes of MELD score after 3, 5, 7 and 10 years of treatment'}, {'measure': 'Dynamic changes of liver stiffness values measured by Transient Elastography', 'timeFrame': 'year 3, 5, 7 and 10', 'description': 'Dynamic changes of liver stiffness values after 3, 5, 7 and 10 years of treatment'}, {'measure': 'Improvement of life quality (SF36 and EQ-5D)', 'timeFrame': 'year 3, 5, 7 and 10', 'description': 'Improvement of life quality after 3, 5, 7 and 10 years of treatment'}]}, 'conditionsModule': {'conditions': ['Hepatitis B', 'Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '20558165', 'type': 'BACKGROUND', 'citation': "Arvaniti V, D'Amico G, Fede G, Manousou P, Tsochatzis E, Pleguezuelo M, Burroughs AK. Infections in patients with cirrhosis increase mortality four-fold and should be used in determining prognosis. Gastroenterology. 2010 Oct;139(4):1246-56, 1256.e1-5. doi: 10.1053/j.gastro.2010.06.019. Epub 2010 Jun 14."}, {'pmid': '15470215', 'type': 'BACKGROUND', 'citation': 'Liaw YF, Sung JJ, Chow WC, Farrell G, Lee CZ, Yuen H, Tanwandee T, Tao QM, Shue K, Keene ON, Dixon JS, Gray DF, Sabbat J; Cirrhosis Asian Lamivudine Multicentre Study Group. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med. 2004 Oct 7;351(15):1521-31. doi: 10.1056/NEJMoa033364.'}, {'pmid': '41234032', 'type': 'DERIVED', 'citation': 'Zhang J, Chen S, Zhou J, Wang B, Wu X, Xu X, Zhao X, Kong Y, Ou X, Sun Y, You H. Serial Liver Stiffness Measurement and Serum Biomarkers Are Not Strong Predictors of the Regression of Fibrosis among Chronic Hepatitis B Patients Receiving Antiviral Therapy Based on Triple Liver Biopsies. Gut Liver. 2025 Nov 15;19(6):889-899. doi: 10.5009/gnl250008.'}, {'pmid': '34843068', 'type': 'DERIVED', 'citation': 'Wu X, Hong J, Zhou J, Sun Y, Li L, Xie W, Piao H, Xu X, Jiang W, Feng B, Chen Y, Xu M, Cheng J, Meng T, Wang B, Chen S, Kong Y, Ou X, You H, Jia J. Health-related quality of life improves after entecavir treatment in patients with compensated HBV cirrhosis. Hepatol Int. 2021 Dec;15(6):1318-1327. doi: 10.1007/s12072-021-10240-4. Epub 2021 Nov 29.'}, {'pmid': '33460002', 'type': 'DERIVED', 'citation': 'Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18.'}, {'pmid': '32568867', 'type': 'DERIVED', 'citation': 'Yang JM, Chen LP, Wang YJ, Lyu B, Zhao H, Shang ZY, Li J, Fan ZY, Wu SD, Ming X, Li X, Huang SP, Cheng JL. Entecavir add-on Peg-interferon therapy plays a positive role in reversing hepatic fibrosis in treatment-naive chronic hepatitis B patients: a prospective and randomized controlled trial. Chin Med J (Engl). 2020 Jul 20;133(14):1639-1648. doi: 10.1097/CM9.0000000000000857.'}]}, 'descriptionModule': {'briefSummary': 'Patients who have completed 2 years follow-up of the past National 12th Five-Year Major Project on Infectious Diseases will receive another 8 years treatment with entecavir (10 years in total). Collect serology, imaging, and other clinical data to evaluate the incidence and mortality of decompensated cirrhosis and hepatocellular carcinoma. Understand the effects of long-term antiviral therapy on HBV-induced liver fibrosis/cirrhosis.', 'detailedDescription': 'Patients who have completed 2-years entecavir-based treatment in Regress Study will receive another 8 years of entecavir extension therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBV-DNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan; A third liver biopsy will be performed at the 5th year of treatment in patients who have significant fibrosis at second biopsy. CT /MRI and endoscopy will be performed at baseline and the 5th and 10th year of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Subjects who completed the 2 years of entecavir-based therapy in Regress study; Subjects who are willing to participate the extension study.\n\nExclusion Criteria:\n\n\\- Any complication of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases; Pregnant women; Subjects who could not compliance with the protocol judged by investigators; Subjects who are not suitable for the study judged by investigators.'}, 'identificationModule': {'nctId': 'NCT02849132', 'briefTitle': 'Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Effect of Entecavir Treatment on Regression and Long-term Disease Outcome in Patients With HBV-induced Liver Fibrosis and Cirrhosis (Regress Extension Study)', 'orgStudyIdInfo': {'id': '2016ZX10002011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'entecavir oral，0.5mg daily for 8 years', 'interventionNames': ['Drug: Entecavir']}], 'interventions': [{'name': 'Entecavir', 'type': 'DRUG', 'description': 'oral entecavir 0.5mg daily for 8 years', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': '302 Military Hospital Of China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing YouAn Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'NanfangHospital,Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '050051', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The Third Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '50021', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Shijiazhuang Fifth Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College , Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '133000', 'city': 'Yanji', 'state': 'Jilin', 'country': 'China', 'facility': 'The Affiliated Hospital of Yanbian University', 'geoPoint': {'lat': 42.88825, 'lon': 129.50241}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital, Shanghai Jiao Tong University, School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200080', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201508', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Public Health Clinical Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '30001', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'The First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '710032', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Xijing Hospital, Fourth Military Medical University', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '300380', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Xiqing Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310016', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '300170', 'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Third Central Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Xiaojuan Ou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Friendship Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Peking University People's Hospital", 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Yanbian University', 'class': 'UNKNOWN'}, {'name': 'Shanghai Public Health Clinical Center', 'class': 'OTHER_GOV'}, {'name': 'Beijing YouAn Hospital', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice-Director of Liver Research Center', 'investigatorFullName': 'Xiaojuan Ou', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}