Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT02734966
Status:
COMPLETED
Last Update Posted:
2016-09-27
First Post:
2016-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056486', 'term': 'Chemical and Drug Induced Liver Injury'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011041', 'term': 'Poisoning'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C521270', 'term': '18alpha,20beta-hydroxy-11-oxo-norolean-12-en-3beta-yl-2-O-beta-D-glucopyranurosyl-alpha-D-glucopyranosiduronate magnesium tetrahydrate'}, {'id': 'D036881', 'term': 'Long-Term Synaptic Depression'}, {'id': 'D008625', 'term': 'Tiopronin'}], 'ancestors': [{'id': 'D009473', 'term': 'Neuronal Plasticity'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D034442', 'term': 'N-substituted Glycines'}, {'id': 'D005998', 'term': 'Glycine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-25', 'studyFirstSubmitDate': '2016-04-06', 'studyFirstSubmitQcDate': '2016-04-06', 'lastUpdatePostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of ALT normalization at week 4 of treatment', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'rates of ALT normalization at weeks 1, 2, and 3 of treatment', 'timeFrame': '3 weeks'}, {'measure': 'change of ALT at weeks 1, 2, 3 and 4 of treatment;', 'timeFrame': '4 weeks'}, {'measure': 'change of AST at weeks 1, 2, 3 and 4 of treatment.', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug-Induced', 'Acute Liver Injury'], 'conditions': ['Drug-Induced Liver Injury']}, 'referencesModule': {'references': [{'pmid': '9303497', 'type': 'BACKGROUND', 'citation': 'Maria VA, Victorino RM. Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis. Hepatology. 1997 Sep;26(3):664-9. doi: 10.1002/hep.510260319.'}, {'pmid': '16496329', 'type': 'BACKGROUND', 'citation': 'Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006 Mar;43(3):618-31. doi: 10.1002/hep.21095.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety, effective dosage and treatment of Magnesium Isolycyrrhizinate Injection to cure the acute drug-induced liver injury compared with the Tiopronin Injection.', 'detailedDescription': 'The pharmacology research shows that Magnesium Isoglycyrrhizinate could significantly decrease the elevation of ALT and AST coursed by carbon tetrachloride, D-galactosamine and Thioacetamide. It could also significantly reduce the injury on the liver coursed by D-galacosamine and immunologic factors. Magnesium Isoglycyrrhizinate with strong anti-inflammatory effect could protect the liver cell and improve the liver function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RACUM ≥6\n* ALTs ≥2ULN, but TBiL is ≤ 3 ULN.It may be associated with AST or ALP or TBiL exceed the upper limit of normal\n* Liver biochemical abnormalities duration of no more than three months\n* Patients need to fully understand and sign the inform consent form.\n\nExclusion Criteria:\n\n* The liver injury is caused by other diseases, such as virus hepatitis, alcohol and non-alcohol fatty liver disease or the autoimmune liver disease.\n* The patients with the acute hepatic failure or hepatic decompensation, such as hepatic encephalopathy, ascites, albumin is ≤ 35g/L, prothrombin time is elongated more than 2 seconds compared to its normal range.\n* The value of the TBiL is \\> 3ULN.\n* The value of serum creatinine is \\> 1.5ULN.\n* Patients who have severe organic diseases on heart, lungs, brain, kidney and gastrointestinal tract.\n* Patients who are taking the drugs that might interfere the trial.\n* Patients who are allergic or intolerant to the study drug.\n* Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis.\n* Patients who are compliant with protocol.\n* Women who are pregnant, breast-feeding or with childbearing potential.\n* Patients who have attended other clinical trials within 3 months.\n* Not appropriate to be included after assessing by the investigators.\n\nULN=Upper Limited Normal'}, 'identificationModule': {'nctId': 'NCT02734966', 'briefTitle': 'Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Active Control Phase II Study to Investigate Multiple Dosage and Treatments of Magnesium Isoglycyrrhizinate Injection to Cure the Acute Drug-induced Liver Injury', 'orgStudyIdInfo': {'id': 'ZTDQ01341301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'arm 1', 'description': 'lower dose： Magnesium Isoglycyrrhizinate injection 100mg OD for 4 weeks', 'interventionNames': ['Drug: Magnesium Isoglycyrrhizinate Injection 100mg OD']}, {'type': 'EXPERIMENTAL', 'label': 'arm 2', 'description': 'higher dose：Magnesium Isoglycyrrhizinate injection 200mg OD for 4 weeks.', 'interventionNames': ['Drug: Magnesium Isoglycyrrhizinate Injection 200mg OD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tiopronin Injection', 'description': 'Tiopronin Injection 200mg OD for 4 weeks', 'interventionNames': ['Drug: Tiopronin Injection']}], 'interventions': [{'name': 'Magnesium Isoglycyrrhizinate Injection 100mg OD', 'type': 'DRUG', 'otherNames': ['Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'], 'description': 'Magnesium Isoglycyrrhizinate Injection 100mg OD', 'armGroupLabels': ['arm 1']}, {'name': 'Magnesium Isoglycyrrhizinate Injection 200mg OD', 'type': 'DRUG', 'otherNames': ['Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'], 'description': 'Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks', 'armGroupLabels': ['arm 2']}, {'name': 'Tiopronin Injection', 'type': 'DRUG', 'otherNames': ['Jinan Limin Pharmaceutical Co., Ltd.'], 'description': 'Tiopronin Injection 200mg OD', 'armGroupLabels': ['Tiopronin Injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Chest Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Pulmonary Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "85 Hospital of People's Liberation Army", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Sixth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Integrated Chinese and Western Medicine Hospital of Zhejiang Province', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Minde Zeng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}