Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-02-12 @ 7:23 AM
Study NCT ID:
NCT04028869
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2019-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Therapy of Autoimmune Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-20', 'studyFirstSubmitDate': '2019-07-20', 'studyFirstSubmitQcDate': '2019-07-20', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The ratio of sustained biochemical responses', 'timeFrame': 'at 96 weeks and 144 weeks after treatment', 'description': 'The ratio of sustained biochemical responses at 96 weeks and 144 weeks after treatment with glycyrrhizic acid preparation in patients with autoimmune liver disease'}], 'secondaryOutcomes': [{'measure': 'The incidence of decompensated liver cirrhosis and liver cancer and its complications', 'timeFrame': 'at 96 and 144 weeks after treatment', 'description': 'The incidence of decompensated liver cirrhosis and liver cancer and its complications at 96 and 144 weeks after treatment with glycyrrhizic acid in patients with autoimmune liver disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autoimmune liver disease', 'glycyrrhizic acid', 'liver function'], 'conditions': ['Autoimmune Liver Disease']}, 'descriptionModule': {'briefSummary': 'This study was a retrospective clinical observation cohort study. All patients with autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, were enrolled. Clinical follow-up data including demographics, hematuria, and liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies, special proteins and liver imaging (liver ultrasound) examination. The clinical effect of glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and the safety during treatment were analyzed.', 'detailedDescription': 'This study was a retrospective clinical observation cohort study. All patients with autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, were enrolled. Clinical follow-up data including demographics, hematuria, and liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies, special proteins and liver imaging (liver ultrasound) examination. The clinical effect of glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and the safety during treatment were analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients with autoimmune liver disease: All enrolled autoimmune liver diseases meet the diagnostic criteria of China's Consensus on Diagnosis and Treatment of Autoimmune Liver Disease (2015);", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\) Patients with autoimmune liver disease: All enrolled autoimmune liver diseases meet the diagnostic criteria of China's Consensus on Diagnosis and Treatment of Autoimmune Liver Disease (2015);\n* 2\\) no hormones and / or immunosuppressants and other liver protection drugs;\n* 3\\) Sign the written informed consent form.\n\nExclusion Criteria:\n\n* 1\\) Combine other hepatitis virus (HCV, HDV) infections;\n* 2\\) viral liver disease;\n* 3\\) HIV infection;\n* 4\\) long-term alcohol abuse and / or other liver damage drugs;\n* 5\\) mental illness;\n* 6\\) Evidence of liver tumors (liver cancer or AFP \\> 100 ng/ml);\n* 7\\) decompensated cirrhosis;\n* 8\\) Serious diseases such as heart, brain, lung, kidney, etc. can not participate in long-term follow-up;\n* 9\\) There are hormones and / or immunosuppressants and other liver protection drugs."}, 'identificationModule': {'nctId': 'NCT04028869', 'briefTitle': 'Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Therapy of Autoimmune Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Ditan Hospital'}, 'officialTitle': 'Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Treatment of Autoimmune Liver Disease', 'orgStudyIdInfo': {'id': 'DTXY018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glycyrrhizin preparation treatment group', 'description': 'Clinical effect of glycyrrhizic acid preparation for 144 weeks of autoimmune liver disease and safety during treatment', 'interventionNames': ['Drug: Glycyrrhizic acid preparation']}], 'interventions': [{'name': 'Glycyrrhizic acid preparation', 'type': 'DRUG', 'description': 'To analyze the clinical effect of glycyrrhizic acid preparation for autoimmune liver disease for 144 weeks and the safety during treatment', 'armGroupLabels': ['Glycyrrhizin preparation treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100015', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'liver disease center, Beijing Ditan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yao Xie, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'liver disease center, Beijing Ditan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Second Division of Liver Diseases', 'investigatorFullName': 'Yao Xie', 'investigatorAffiliation': 'Beijing Ditan Hospital'}}}}