Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-29 @ 11:21 PM
Study NCT ID:
NCT00441493
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2007-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluvastatin Versus Hepatitis C Virus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077340', 'term': 'Fluvastatin'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-26', 'studyFirstSubmitDate': '2007-02-27', 'studyFirstSubmitQcDate': '2007-02-28', 'lastUpdatePostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viral Load Reduction, Liver test changes'}]}, 'conditionsModule': {'keywords': ['Hepatitis C', 'fluvastatin'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.', 'detailedDescription': 'Four different oral doses of fluvastatin will be used for 14 days and the viral load of hepatitis C will be measured weekly. This has been extended to different doses for 9-12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HCV RNA positive\n\nExclusion Criteria:\n\n* Testing positive for alcohol or marijuana'}, 'identificationModule': {'nctId': 'NCT00441493', 'briefTitle': 'Fluvastatin Versus Hepatitis C Virus', 'organization': {'class': 'INDIV', 'fullName': 'Bader, Ted, M.D.'}, 'officialTitle': 'A Dose Finding Study of Fluvastatin for in Vivo Demonstration of Inhibiting Hepatitis C Replication in Patients Infected With Chronic Hepatitis C With Special Attention to the African-American Population.', 'orgStudyIdInfo': {'id': '13035'}, 'secondaryIdInfos': [{'id': '13134'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'fluvastatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'VA Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Ted Bader, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Medical Center and University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bader, Ted, M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'US Department of Veterans Affairs', 'class': 'FED'}]}}}