Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-11 @ 8:51 AM
Study NCT ID:
NCT03920618
Status:
RECRUITING
Last Update Posted:
2024-11-29
First Post:
2019-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D065290', 'term': 'Acute-On-Chronic Liver Failure'}], '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': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C413685', 'term': 'entecavir'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'C442442', 'term': 'tenofovir alafenamide'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2019-04-16', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate in the follow-up', 'timeFrame': '144 week', 'description': 'Whether patients will survive after treatment is observed in the follow-up.'}], 'secondaryOutcomes': [{'measure': 'Model for end-stage liver disease (MELD) score is recorded after treatment', 'timeFrame': '0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week', 'description': 'The calculation of model for end-stage liver disease (MELD) score is: R=0.378ln\\[serum total bilirubin (mg/dl)\\]+1.12ln(prothrombin time international normalized ratio)+0.95ln\\[serum creatinin(mg/dl)\\]+0.64. The higher the MELD score, the higher the mortality rate. MELD score is recorded after treatment.'}, {'measure': 'Ratio of patients with undetectable hepatitis b virus DNA after treatment', 'timeFrame': '4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week', 'description': 'Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 7 time points after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatitis b virus', 'acute-on-chronic liver failure', 'nucleotide', 'nucleoside'], 'conditions': ['Hepatitis B', 'Acute-On-Chronic Liver Failure']}, 'referencesModule': {'references': [{'pmid': '39958923', 'type': 'DERIVED', 'citation': 'Zhang Y, Xu W, Deng Z, Wang L, Zheng X, Zhu X, Li X, Li J, Shu X, Lai J, Peng L, Xie C. Long-term efficacy and safety of tenofovir alafenamide, tenofovir disoproxil fumarate, and entecavir in treating hepatitis B virus-related acute-on-chronic liver failure: A 144-week data analysis. Liver Res. 2024 Oct 24;8(4):295-303. doi: 10.1016/j.livres.2024.10.001. eCollection 2024 Dec.'}]}, 'descriptionModule': {'briefSummary': 'This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.', 'detailedDescription': 'Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of HBV related ACLF. This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV related ACLF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Positive hepatitis b surface antigen or hepatitis b virus DNA \\> 0.5 year;\n2. Age from 12 to 65 years old;\n3. Serum total bilirubin level \\> 10 times upper limit of normal;\n4. Prothrombin time activity \\< 40% or prothrombin time international ratio \\> 1.5；\n5. Do not receive nucleotide/nucleoside analogues treatment in the past half year.\n\nExclusion Criteria:\n\n1. Other active liver diseases;\n2. Hepatocellular carcinoma or other malignancy;\n3. Pregnancy or lactation;\n4. Human immunodeficiency virus infection or congenital immune deficiency diseases;\n5. Severe diabetes, autoimmune diseases;\n6. Other important organ dysfunctions;\n7. Using glucocorticoid;\n8. Patients can not follow-up;\n9. Investigator considering inappropriate.'}, 'identificationModule': {'nctId': 'NCT03920618', 'acronym': 'HBV', 'briefTitle': 'Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF', 'organization': {'class': 'OTHER', 'fullName': 'Third Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure', 'orgStudyIdInfo': {'id': 'PL6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ETV group', 'description': '50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.', 'interventionNames': ['Drug: Entecavir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TDF group', 'description': '50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.', 'interventionNames': ['Drug: Tenofovir Disoproxil Fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'TAF group', 'description': '50 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.', 'interventionNames': ['Drug: Tenofovir Alafenamide']}], 'interventions': [{'name': 'Entecavir', 'type': 'DRUG', 'otherNames': ['Baraclude'], 'description': 'Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.', 'armGroupLabels': ['ETV group']}, {'name': 'Tenofovir Disoproxil Fumarate', 'type': 'DRUG', 'otherNames': ['Viread'], 'description': 'Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.', 'armGroupLabels': ['TDF group']}, {'name': 'Tenofovir Alafenamide', 'type': 'DRUG', 'otherNames': ['Vemlidy'], 'description': 'Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.', 'armGroupLabels': ['TAF group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liang Peng, Doctor', 'role': 'CONTACT', 'email': 'pzp33@hotmail.com', 'phone': '+8613533978874'}], 'facility': 'Third Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Wenxiong Xu, Doctor', 'role': 'CONTACT', 'email': 'xwx1983@163.com', 'phone': '+8613760783281'}, {'name': 'Liang Peng, Doctor', 'role': 'CONTACT', 'email': 'pzp33@hotmail.com', 'phone': '+8613533978874'}], 'overallOfficials': [{'name': 'Liang Peng, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Third Affiliated Hospital, Sun Yat-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professer', 'investigatorFullName': 'Liang Peng', 'investigatorAffiliation': 'Third Affiliated Hospital, Sun Yat-Sen University'}}}}