Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-02-28 @ 11:20 AM
Study NCT ID:
NCT02024295
Status:
UNKNOWN
Last Update Posted:
2014-05-29
First Post:
2013-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006519', 'term': 'Hepatitis, Alcoholic'}], 'ancestors': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-28', 'studyFirstSubmitDate': '2013-12-19', 'studyFirstSubmitQcDate': '2013-12-25', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Liver biopsy', 'timeFrame': '48 weeks', 'description': 'Liver biopsy is not demanded'}], 'primaryOutcomes': [{'measure': 'response rate of serum total bilirubin', 'timeFrame': '6 weeks', 'description': 'response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30%'}], 'secondaryOutcomes': [{'measure': 'level of serum direct bilirubin', 'timeFrame': '6 weeks and 48 weeks'}, {'measure': 'level of serum bile acids', 'timeFrame': '6 weeks and 48 weeks'}, {'measure': 'level of glutamic pyruvic transaminase', 'timeFrame': '6 weeks and 48 weeks'}, {'measure': 'level of glutamic oxaloacetic transaminase', 'timeFrame': '6 weeks and 48 weeks'}, {'measure': 'level of alkaline phosphatase', 'timeFrame': '6 weeks and 48 weeks'}, {'measure': 'level of gamma-glutamyl transpeptidase', 'timeFrame': '6 weeks and 48 weeks'}, {'measure': 'level of hyaluronic acid', 'timeFrame': '6 weeks and 48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis, Alcoholic']}, 'descriptionModule': {'briefSummary': 'To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.', 'detailedDescription': 'randomize first time for core treatment stage for 6 weeks, then randomized second time for extend treatment for 42 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index range 19-30kg/m2\n* Alcohol Drinking history more than 5 years, for male ≥ 40g/ day, for female ≥ 20g/ day;\n* STB from 2 to 10X ULN;\n* ALP\\>1.5X ULN or GGT\\>3X ULN\n\nExclusion Criteria: any one of below,\n\n* active virus hepatitis, or anti-HIV(+)\n* exclude other hepatic disease: non-alcoholic fatty liver, drug-induced liver injury, autoimmune hepatitis( AMA/ANA\\>1:100), Wilson disease, hemochromatosis or other hepatic disease; obstructive cholestasis\n* other non-hepatic diseases caused jaundice\n* primary hepatic carcinoma'}, 'identificationModule': {'nctId': 'NCT02024295', 'briefTitle': 'Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zhejiang Hisun Pharmaceutical Co. Ltd.'}, 'officialTitle': 'Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis', 'orgStudyIdInfo': {'id': 'XMX-AH-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ademethionine', 'description': 'ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.', 'interventionNames': ['Drug: Ademethionine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Polyene Phosphatidyl choline', 'description': 'Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.', 'interventionNames': ['Drug: Polyene Phosphatidyl choline', 'Drug: Ademethionine']}], 'interventions': [{'name': 'Ademethionine', 'type': 'DRUG', 'otherNames': ['ademethionine for 6 weeks'], 'description': 'ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.', 'armGroupLabels': ['Ademethionine']}, {'name': 'Polyene Phosphatidyl choline', 'type': 'DRUG', 'otherNames': ['Polyene Phosphatidyl choline for 6 weeks'], 'description': 'Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.', 'armGroupLabels': ['Polyene Phosphatidyl choline']}, {'name': 'Ademethionine', 'type': 'DRUG', 'otherNames': ['stage 2, ademethionine for 42 weeks.'], 'description': 'after 6 weeks of core treatment stage, then ademethionine 1000mg bid or qd orally for 42 weeks', 'armGroupLabels': ['Ademethionine', 'Polyene Phosphatidyl choline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100015', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Cheng', 'role': 'CONTACT', 'email': 'jun.cheng.ditan@gmail.com', 'phone': '8610-84322566'}], 'facility': 'Beijing Ditan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100015', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Cheng', 'role': 'CONTACT'}], 'facility': 'Jun Cheng', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jun Cheng', 'role': 'CONTACT', 'email': 'jun.cheng.ditan@gmail.com', 'phone': '8610-84322000'}], 'overallOfficials': [{'name': 'Jun Cheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Ditan Hospital affiliated ffiated to Capital Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Hisun Pharmaceutical Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}