Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:42 AM
Study NCT ID:
NCT07481032
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], '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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1034}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-15', 'studyFirstSubmitDate': '2026-03-15', 'studyFirstSubmitQcDate': '2026-03-15', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up', 'timeFrame': 'From enrollment to the end of treatment at 96 weeks', 'description': 'Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up'}], 'secondaryOutcomes': [{'measure': 'Non-HCC liver-related events and other the clinical changes or incidence rates', 'timeFrame': 'From enrollment to the end of treatment at 96 weeks', 'description': '1. Liver-related death;\n2. Incidence of non-HCC events and non-liver-related death;\n3. Changes in liver function, liver fibrosis degree, and tumor markers;\n4. Trends in the four diagnostic methods of traditional Chinese medicine and changes in TCM syndrome scores;\n5. Incidence of adverse events (AEs) and serious adverse events (SAEs).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cirrhosis, Liver', 'Hepatocellular Carcinoma (HCC)', 'HEPATITIS B CHRONIC']}, 'descriptionModule': {'briefSummary': 'This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Qi-zhi-xue\\_yu syndrome and have an aMAP score \\>60 points. The objective is to evaluate whether combining Bie-jia-ruan-gan with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily signed informed consent form\n* Aged 18-65 years\n* Traditional Chinese Medicine (TCM) syndrome type: Qi-zhi -xue-yu\n* Meeting the diagnostic criteria for hepatitis B-related cirrhosis\n* aMAP score \\> 60\n\nExclusion Criteria:\n\n* \\[Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies\n* Pregnant or lactating women\n* Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding)\n* Concomitant liver diseases, including but not limited to hepatitis C virus infection, human immunodeficiency virus infection, alcoholic liver disease, autoimmune liver disease, or drug-induced liver injury\n* Severe cardiac, renal, respiratory, or hematopoietic system diseases\n* Determined by the investigator to be unsuitable for participation in this trial'}, 'identificationModule': {'nctId': 'NCT07481032', 'briefTitle': 'Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Effect of Fufang Biejiaruangan Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'NFEC-2026-139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Standard antiviral therapy + Biejia-Ruangan compound', 'description': 'receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy.', 'interventionNames': ['Drug: Biejia-Ruangan compound']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator: Standard antiviral therapy + Placebo', 'description': 'receive Bie-jia-ruan-gan simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy', 'interventionNames': ['Drug: Biejia-Ruangan compound simulant']}], 'interventions': [{'name': 'Biejia-Ruangan compound', 'type': 'DRUG', 'description': 'receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy', 'armGroupLabels': ['Experimental: Standard antiviral therapy + Biejia-Ruangan compound']}, {'name': 'Biejia-Ruangan compound simulant', 'type': 'DRUG', 'description': 'receive Biejia-ruangan compound simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy', 'armGroupLabels': ['Placebo Comparator: Standard antiviral therapy + Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rong Fan', 'role': 'CONTACT', 'email': 'rongfansmu@163.com', 'phone': '020-62786534'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': "Shenzhen Third People's Hospital", 'class': 'OTHER'}, {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, {'name': 'Beijing 302 Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}