Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-02 @ 4:04 PM
Study NCT ID:
NCT00487318
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2007-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D000077340', 'term': 'Fluvastatin'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-20', 'studyFirstSubmitDate': '2007-06-15', 'studyFirstSubmitQcDate': '2007-06-15', 'lastUpdatePostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained Viral response', 'timeFrame': '72 weeks'}], 'secondaryOutcomes': [{'measure': 'Viral load at 4, 12 and 24 weeks', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fluvastatin', 'hepatitis C', 'chronic hepatitis C', 'not previously treated with pegylated interferon and ribavirin'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Not previously treated.\n* Off alcohol and marijuana for 6 months\n* HCV RNA positive\n\nExclusion Criteria:\n\n* HIV positive\n* Advanced liver disease\n* Advanced cardiopulmonary disease\n* Chronic renal failure'}, 'identificationModule': {'nctId': 'NCT00487318', 'briefTitle': 'Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin', 'organization': {'class': 'INDIV', 'fullName': 'Bader, Ted, M.D.'}, 'officialTitle': 'A Randomized Controlled Trial of Adding Fluvastatin to Standard Medical Treatment (SMT) and a Pilot Trial of Rosuvastatin and Other Statins With SMT, for Patients Infected With Chronic Hepatitis C Who Are Naive to Therapy.', 'orgStudyIdInfo': {'id': '13358'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 Plus statin', 'description': 'The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin.', 'interventionNames': ['Drug: fluvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Administration of the standard of care for hepatitis C of peginterferon and ribavirin.', 'interventionNames': ['Drug: standard of care']}], 'interventions': [{'name': 'standard of care', 'type': 'DRUG', 'description': 'peginterferon/RBV', 'armGroupLabels': ['2']}, {'name': 'fluvastatin', 'type': 'DRUG', 'otherNames': ['Lescol'], 'description': 'Add fluvastatin at 20-40 mg/day to standard of care', 'armGroupLabels': ['Arm 1 Plus statin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Veterans Administration Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Ted F Bader, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OUHSC and VAMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bader, Ted, M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Liver Diseases, VA Medical Center', 'investigatorFullName': 'Ted Bader, MD', 'investigatorAffiliation': 'Bader, Ted, M.D.'}}}}