Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-01 @ 10:11 AM
Study NCT ID:
NCT00509418
Status:
COMPLETED
Last Update Posted:
2009-01-12
First Post:
2007-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551853', 'term': 'Viusid'}, {'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-09', 'studyFirstSubmitDate': '2007-07-30', 'studyFirstSubmitQcDate': '2007-07-30', 'lastUpdatePostDateStruct': {'date': '2009-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 24 weeks (end of the treatment).', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Alanine aminotransferase levels (end of the treatment), δ-glutamyltransferase levels (end of the treatment), Body weight, Body Mass Index, Waist circumference (end of the treatment) Insulin resistance (HOMA) (end of the treatment)', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nonalcoholic steatohepatitis', 'Nonalcoholic Fatty Liver', 'Nutritional supplement', 'Diet', 'Exercise'], 'conditions': ['Nonalcoholic Steatohepatitis']}, 'referencesModule': {'references': [{'pmid': '17311621', 'type': 'BACKGROUND', 'citation': 'Vilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59. doi: 10.1111/j.1478-3231.2006.01411.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in combination with diet and exercise improve the histological results (steatosis, necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis)\n* Age between 18 and 70 years\n* Ability to provide informed consent\n* Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)\n\nExclusion Criteria:\n\n* Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency)\n* Pregnancy or lactation\n* Decompensated cirrhosis\n* Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery\n* Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil\n* Fasting glucose levels greater than 250 mg per deciliter (13.3 mmol per liter)\n* Contraindication to liver biopsy\n* Refusal to participate in the study\n* Concomitant disease with reduced life expectancy\n* Severe psychiatric conditions\n* Drug dependence'}, 'identificationModule': {'nctId': 'NCT00509418', 'briefTitle': 'Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catalysis SL'}, 'officialTitle': 'Efficacy and Safety of Viusid, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized, Controlled and Open Label Study', 'orgStudyIdInfo': {'id': 'VIUNASH-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Viusid, a nutritional supplement, in combination with controlled diet and exercise', 'interventionNames': ['Dietary Supplement: Viusid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Controlled diet and exercise', 'interventionNames': ['Other: Hypocaloric Diet with controlled exercise']}], 'interventions': [{'name': 'Viusid', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nutritional supplement'], 'description': 'Viusid, a nutritional supplement. Three oral sachets Daily 24 weeks', 'armGroupLabels': ['A']}, {'name': 'Hypocaloric Diet with controlled exercise', 'type': 'OTHER', 'otherNames': ['lifestyle modification'], 'description': 'Modified ADA diet in combination with controlled exercise daily 24 weeks', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Vedado', 'state': 'La Habana', 'country': 'Cuba', 'facility': 'National Institute of Gastroenterology', 'geoPoint': {'lat': 23.13767, 'lon': -82.39339}}], 'overallOfficials': [{'name': 'Adelaida Rodríguez de Miranda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Gastroenterology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catalysis SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Eduardo Vilar Gómez', 'oldOrganization': 'National Institute of Gastroenterology'}}}}