Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 1:51 AM
Study NCT ID:
NCT04553003
Status:
UNKNOWN
Last Update Posted:
2022-04-29
First Post:
2020-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial
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': 'D011241', 'term': 'Prednisone'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2020-08-30', 'studyFirstSubmitQcDate': '2020-09-16', 'lastUpdatePostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients that AST or ALT decline 25% at day 4', 'timeFrame': 'Change from Baseline ALT and AST at day4', 'description': 'AST or ALT decline 25% at day 4'}], 'secondaryOutcomes': [{'measure': 'percentage of patients that AST or ALT decline 50% at day 8', 'timeFrame': 'Change from Baseline ALT and AST at day8', 'description': 'AST or ALT decline 25% at day 8'}, {'measure': 'the time needed when TBIL decline 50%', 'timeFrame': 'up to 2 weeks', 'description': 'TBIL decline 50%; time'}, {'measure': 'incidence of side effects', 'timeFrame': 'up to 2 years', 'description': 'infection，uncontrolled hypertension or hyperglycemia'}, {'measure': 'relapse rate in 12 months after drug withdrawal', 'timeFrame': '12 months after drug withdrawal', 'description': 'relapse rate'}, {'measure': 'mortality in 12 months after drug withdrawal', 'timeFrame': '12 months after drug withdrawal', 'description': 'mortality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glucocorticosteroid'], 'conditions': ['Drug-induced Liver Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of glucocorticosteroid for treatment of drug-induced liver injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of DILI\n2. RUCAM score≥6 and with liver histology\n3. Meet any of the following conditions:\n\n 1. TBIL ≥ 10 fold ULN ;\n 2. TBIL ≥ 5 fold ULN and serum AST or ALT ≥ 20 fold ULN\n\nExclusion Criteria:\n\n1. An chronic onset (≥6 months)\n2. Other liver diseases, such as autoimmune liver diseases, viral hepatitis, etc\n3. with contraindications of glucocorticoid'}, 'identificationModule': {'nctId': 'NCT04553003', 'briefTitle': 'Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial', 'orgStudyIdInfo': {'id': 'LYang'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'glucocorticoid+hepatoprotectant group', 'description': 'glucocorticoid 0.4mg/kg/d+hepatoprotectant for 7d', 'interventionNames': ['Drug: Glucocorticoids+hepatoprotectant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hepatoprotectant group', 'description': 'hepatoprotectant for 7d', 'interventionNames': ['Drug: hepatoprotectant']}], 'interventions': [{'name': 'Glucocorticoids+hepatoprotectant', 'type': 'DRUG', 'otherNames': ['prednisone', 'methylprednisolone'], 'description': 'Participants received glucocorticoids (0.4mg/kg/d po.) and hepatoprotectant for 7 days.', 'armGroupLabels': ['glucocorticoid+hepatoprotectant group']}, {'name': 'hepatoprotectant', 'type': 'DRUG', 'otherNames': ['Ademetionine1,4-Butanedisulfonate', 'Polyene Phosphatidyl choline'], 'description': 'Participants received hepatoprotectants (i.v.gtt.) for 7 days.', 'armGroupLabels': ['hepatoprotectant group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Yang, MD', 'role': 'CONTACT', 'email': 'yangli_hx@scu.edu.cn', 'phone': '+86 18980601276'}, {'name': 'Yi Shen, MM', 'role': 'CONTACT', 'email': '156450779@qq.com', 'phone': '+86 18280097412'}, {'name': 'Yi Shen, MM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Li Yang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Li Yang', 'investigatorAffiliation': 'West China Hospital'}}}}