Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT01938820
Status:
COMPLETED
Last Update Posted:
2018-07-27
First Post:
2013-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimized Treatment and Regression of HBV-induced Early Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C413685', 'term': 'entecavir'}, {'id': 'D000077596', 'term': 'Thymalfasin'}], 'ancestors': [{'id': 'D013947', 'term': 'Thymosin'}, {'id': 'D013951', 'term': 'Thymus Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-26', 'studyFirstSubmitDate': '2013-09-05', 'studyFirstSubmitQcDate': '2013-09-05', 'lastUpdatePostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regression of HBV-induced liver cirrhosis', 'timeFrame': '1.5 to 2 years', 'description': 'Liver cirrhosis regression of 1 point by Ishak scoring system'}], 'secondaryOutcomes': [{'measure': 'Child-Pugh score', 'timeFrame': '1 year and 2 years', 'description': 'Child-Pugh score change after 1 and 2-year treatment'}, {'measure': 'HBVDNA undetectable rate', 'timeFrame': '1 year and 2 years', 'description': 'The HBVDNA undetectable rate after 1 and 2-year treatment.'}, {'measure': 'Fibroscan value', 'timeFrame': '1 year and 2 years', 'description': 'Fibroscan value change after 1 and 2-year treatment'}, {'measure': 'Life Quality', 'timeFrame': '1 year and 2 years', 'description': 'Life quality change after 1 and 2-year treatment by SF-36 and EQ-5D questionaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis B', 'Liver Cirrhosis', 'Regression', 'Efficacy'], 'conditions': ['Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '39373164', 'type': 'DERIVED', 'citation': 'Lu Z, Sun YM, Chen S, Meng T, Wang B, Zhou J, Wu X, Zhao X, Ou X, Kong YY, Jia J, Zhao X, You H. Multiple Low-Level Viraemia Suggest Hindered Liver Fibrosis Regression in Chronic Hepatitis B Patients During Antiviral Therapy. J Viral Hepat. 2024 Dec;31(12):898-902. doi: 10.1111/jvh.14012. Epub 2024 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year, entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients from age 18 to 65 years old;\n2. Male or female;\n3. Treatment-naive patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) who consent to undergo liver biopsy before and after treatment;\n4. Patients with HBeAg-positive, HBVDNA\\>2×10\\<3\\>IU/ml or patients with HBeAg-negative, HBVDNA\\>2×10\\<2\\> IU/ml；\n5. Agree to be followed up regularly;\n6. Signature of written informed consent.\n\nExclusion Criteria:\n\n1. Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;\n2. Patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for drugs used in this study;\n3. Patients with HCV or HIV infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, severe non-alcoholic fatty liver disease or other chronic liver diseases;\n4. Patients with baseline AFP level higher than 100 ng/ml and possible malignant lesion on image, or AFP level higher than 100 ng/ml for more than three months;\n5. Creatinine \\>1.5×ULN;\n6. Patients with other uncured malignant tumors;\n7. Patients with severe diseases of heart, lung, kidney, brain, blood or other organs;\n8. Patients with any other reasons not suitable for the study.'}, 'identificationModule': {'nctId': 'NCT01938820', 'briefTitle': 'Optimized Treatment and Regression of HBV-induced Early Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Optimized Treatment and Regression of HBV-induced Early Cirrhosis', 'orgStudyIdInfo': {'id': '2013ZX10002004-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Entecavir Therapy', 'description': 'Entecavir monotherapy:\n\nentecavir, 0.5mg, qd, oral, for 2 years.', 'interventionNames': ['Drug: entecavir']}, {'type': 'EXPERIMENTAL', 'label': 'Entecavir plus Thymosin-α', 'description': 'entecavir plus Thymosin-α 1.6μg, Twice a week, ih, in the middle of 1 year.', 'interventionNames': ['Drug: entecavir', 'Drug: Thymosin-α']}], 'interventions': [{'name': 'entecavir', 'type': 'DRUG', 'otherNames': ['entecavir dispersible tablets'], 'description': 'anti-viral therapy', 'armGroupLabels': ['Entecavir Therapy', 'Entecavir plus Thymosin-α']}, {'name': 'Thymosin-α', 'type': 'DRUG', 'otherNames': ['Zadaxin'], 'description': 'antiviral and antifibrosis therapy', 'armGroupLabels': ['Entecavir plus Thymosin-α']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100015', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Ditan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's 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': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing YouAn Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100871', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '050021', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Shijiazhuang Fifth Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '300030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science ＆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': 'Huashan Hospital, FuDan University', '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 First People's 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': '030001', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'The First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '300162', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': "The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force", '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}}], 'overallOfficials': [{'name': 'Hong You, Doctor', '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': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Peking University', 'class': 'OTHER'}, {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Shanghai Public Health Clinical Center', 'class': 'OTHER_GOV'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, {'name': 'Beijing YouAn Hospital', 'class': 'OTHER'}, {'name': 'Peking University First Hospital', 'class': 'OTHER'}, {'name': 'Beijing 302 Hospital', 'class': 'OTHER'}, {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, {'name': 'Huashan Hospital', 'class': 'OTHER'}, {'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, {'name': 'Fifth Hospital of Shijiazhuang City', 'class': 'OTHER'}, {'name': "Logistics University of Chinese People's Armed Police Forces", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Shanxi Medical University', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Yanbian University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice-Director of Liver Research Center', 'investigatorFullName': 'Hong You', 'investigatorAffiliation': 'Beijing Friendship Hospital'}}}}