Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-04 @ 7:24 PM
Study NCT ID:
NCT01406704
Status:
TERMINATED
Last Update Posted:
2011-08-19
First Post:
2011-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077154', 'term': 'Rosiglitazone'}, {'id': 'D008063', 'term': 'Thioctic Acid'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'because of withdrawal of Avandia sale due to its risks outweigh its benefits', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-18', 'studyFirstSubmitDate': '2011-07-27', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2011-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histological evaluation', 'timeFrame': '24 weeks', 'description': 'NASH Histological scoring system'}], 'secondaryOutcomes': [{'measure': 'Biomechanical measurement', 'timeFrame': '24 weeks', 'description': 'liver function test, insulin resistance'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['NASH (Non-alcoholic Steato-hepatitis)']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic acid, antioxidant on patients with pathologically proved NASH (non-alcoholic steato-hepatitis).', 'detailedDescription': 'Duration: 24 week-intervention Study Group: Four arms\n\n* Control: no intervention\n* Rosiglitazone: rosiglitazone (8 mg/day)\n* alpha-lipoic acid: alpha-lipoic acid (1800 mg/day)\n* Rosiglitazone/alpha-lipoic acid: combination of rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* the patients with pathologically proved NASH (non-alcoholic steato-hepatitis)\n\nExclusion Criteria:\n\n* alcohol consumption \\> 20g/day\n* viral hepatitis B and C\n* autoimmune hepatitis\n* Wilson's disease\n* hemochromatosis\n* alpha-1 antitrypsin deficiency\n* breast-feeding or pregnant females\n* subjects planning to become pregnant\n* severe comorbid medical conditions (such as severe cardiac, pulmonary, renal or psychological problems)\n* those not consenting for the study"}, 'identificationModule': {'nctId': 'NCT01406704', 'briefTitle': 'Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH (Non-alcoholic Steato-hepatitis)', 'orgStudyIdInfo': {'id': 'KCMC-04-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'Rosiglitazone', 'description': 'Rosiglitazone (8 mg/day)', 'interventionNames': ['Drug: Rosiglitazone']}, {'type': 'EXPERIMENTAL', 'label': 'alpha-lipoic acid', 'description': 'alpha-lipoic acid (1800 mg/day)', 'interventionNames': ['Drug: alpha-lipoic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Rosiglitazone/alpha-lipoic acid', 'description': 'combination of Rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)', 'interventionNames': ['Drug: Rosiglitazone/alpha-lipoic acid']}], 'interventions': [{'name': 'Rosiglitazone', 'type': 'DRUG', 'otherNames': ['Avandia'], 'description': 'Rosiglitazone (8 mg/day)', 'armGroupLabels': ['Rosiglitazone']}, {'name': 'alpha-lipoic acid', 'type': 'DRUG', 'otherNames': ['Thioctic acid'], 'description': 'alpha-lipoic acid (1800 mg/day)', 'armGroupLabels': ['alpha-lipoic acid']}, {'name': 'Rosiglitazone/alpha-lipoic acid', 'type': 'DRUG', 'otherNames': ['Avandia/Thioctic acid'], 'description': 'combination of Rosiglitazone (8 mg/day) and Thioctic acid (1800 mg/day)', 'armGroupLabels': ['Rosiglitazone/alpha-lipoic acid']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kun Ho Yoon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Kun Ho Yoon/principal investigator', 'oldOrganization': "Seoul St. Mary's Hospital"}}}}