Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-31 @ 3:08 AM
Study NCT ID:
NCT05088733
Status:
UNKNOWN
Last Update Posted:
2021-11-19
First Post:
2021-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia (YYFZJDTIHBVRHCIA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'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': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2021-10-10', 'studyFirstSubmitQcDate': '2021-10-10', 'lastUpdatePostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': '1 year'}, {'measure': 'quality of life (QOL) questionnaire', 'timeFrame': '1 year', 'description': 'The questionnaire includes appetite, sleep, fatigue, pain, etc.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Clinical research of Yang Yin Fu Zheng Jie Du therapy in HBV related hepatocellular carcinoma induced anemia. The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng Jie Du therapy for patients belong to HBV-HCC induced anemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the criteria of hepatocellular carcinoma\n* Patients who tested positive for hepatitis B surface antigen (HBsAg) for \\>6 months\n* Meet the criteria of anemia\n* Ages Eligible for Study: ≤75 years old;\n* Informed consent from the patient.\n\nExclusion Criteria:\n\n* Patients with upper gastrointestinal bleeding within 3 months before enrollment;\n* History of blood transfusion within 3 months before enrollment;\n* Patient with other chronic hepatopathy, such as AIH, NAFLD, ALD;\n* Serious problem of heart, lung, or kidney with severe dysfunction;\n* Pregnant or child breast feeding women;\n* Mental or cognitive disorders;\n* Participating in other drug trials;\n* Who are allergic to the study drug.'}, 'identificationModule': {'nctId': 'NCT05088733', 'briefTitle': 'Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia (YYFZJDTIHBVRHCIA)', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Ditan Hospital'}, 'officialTitle': 'Yang Yin Fu Zheng Jie Du Therapy in HBV Related Hepatocellular Carcinoma Induced Anemia', 'orgStudyIdInfo': {'id': 'BJDHYZY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yang Yin Fu Zheng Jie Du therapy', 'interventionNames': ['Drug: Yang Yin Fu Zheng Jie Du therapy', 'Other: Routine medical care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Routine medical care', 'interventionNames': ['Other: Routine medical care']}], 'interventions': [{'name': 'Yang Yin Fu Zheng Jie Du therapy', 'type': 'DRUG', 'description': 'Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.', 'armGroupLabels': ['Yang Yin Fu Zheng Jie Du therapy']}, {'name': 'Routine medical care', 'type': 'OTHER', 'description': 'Routine medical care', 'armGroupLabels': ['Routine medical care', 'Yang Yin Fu Zheng Jie Du therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100015', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiyun Yang, doctor', 'role': 'CONTACT', 'email': '13439696988@163.com', 'phone': '+8613439696988'}, {'name': 'Zhiyun Yang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhiyun Yang', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhiyun Yang, doctor', 'role': 'CONTACT', 'email': '13439696988@163.com', 'phone': '+8613439696988'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Archiater, Professor', 'investigatorFullName': 'Zhiyun Yang', 'investigatorAffiliation': 'Beijing Ditan Hospital'}}}}