Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT00684268
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2008-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], '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'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'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': 'D000077385', 'term': 'Silybin'}], 'ancestors': [{'id': 'D012838', 'term': 'Silymarin'}, {'id': 'D044947', 'term': 'Flavonolignans'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2008-05-19', 'studyFirstSubmitQcDate': '2008-05-21', 'lastUpdatePostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'viral response at week 24', 'timeFrame': 'week 24'}], 'secondaryOutcomes': [{'measure': 'sustained virologic response', 'timeFrame': 'week 72'}, {'measure': 'Safety', 'timeFrame': 'week 72', 'description': 'start to end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['silibinin', 'chronic hepatitis C', 'peginterferon', 'ribavirin', 'nonresponders', 'efficacy of iv. silibinin', 'safety'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '21106270', 'type': 'BACKGROUND', 'citation': 'Beinhardt S, Rasoul-Rockenschaub S, Scherzer TM, Ferenci P. Silibinin monotherapy prevents graft infection after orthotopic liver transplantation in a patient with chronic hepatitis C. J Hepatol. 2011 Mar;54(3):591-2; author reply 592-3. doi: 10.1016/j.jhep.2010.09.009. Epub 2010 Oct 14. No abstract available.'}, {'pmid': '18771667', 'type': 'RESULT', 'citation': 'Ferenci P, Scherzer TM, Kerschner H, Rutter K, Beinhardt S, Hofer H, Schoniger-Hekele M, Holzmann H, Steindl-Munda P. Silibinin is a potent antiviral agent in patients with chronic hepatitis C not responding to pegylated interferon/ribavirin therapy. Gastroenterology. 2008 Nov;135(5):1561-7. doi: 10.1053/j.gastro.2008.07.072. Epub 2008 Aug 3.'}, {'pmid': '20709593', 'type': 'RESULT', 'citation': 'Payer BA, Reiberger T, Rutter K, Beinhardt S, Staettermayer AF, Peck-Radosavljevic M, Ferenci P. Successful HCV eradication and inhibition of HIV replication by intravenous silibinin in an HIV-HCV coinfected patient. J Clin Virol. 2010 Oct;49(2):131-3. doi: 10.1016/j.jcv.2010.07.006. Epub 2010 Aug 14.'}, {'pmid': '22155914', 'type': 'RESULT', 'citation': "Rutter K, Scherzer TM, Beinhardt S, Kerschner H, Stattermayer AF, Hofer H, Popow-Kraupp T, Steindl-Munda P, Ferenci P. Intravenous silibinin as 'rescue treatment' for on-treatment non-responders to pegylated interferon/ribavirin combination therapy. Antivir Ther. 2011;16(8):1327-33. doi: 10.3851/IMP1942."}]}, 'descriptionModule': {'briefSummary': 'By chance the investigators found that iv. silibinin has a potent antiviral effect against the hepatitis C virus. Based on the results of the dose finding study (published) te optima dosing schedule is explored.This study will be evaluate whether the highest active dose given for the optimal time combined with standard of care will result in a sustained virologic response (=cure of hepatitis C).', 'detailedDescription': 'Since the publication of the first data the optimal dosing schedule is investigated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nonresponders to full dose PEG-IFN/RBV therapy\n* Liver biopsy within the last 2 year\n\nExclusion Criteria:\n\n* Intolerance to one of the study drugs\n* Coinfection with HIV/HBV'}, 'identificationModule': {'nctId': 'NCT00684268', 'acronym': 'NRSily', 'briefTitle': 'Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Multicenter Study To Evaluate The Efficacy Of Silymarin In Addition To Combination-Therapy With Pegylated Interferon Alfa 2a (Peg-Ifn Alfa 2a) And Ribavirin In Patients With Chronic Hepatitis C', 'orgStudyIdInfo': {'id': 'NRSili'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'on treatment nonresponders', 'description': 'naive patients with null response to peginterferon/ribavirin at week 12 or partial response at week 24', 'interventionNames': ['Drug: Silibinin']}, {'type': 'EXPERIMENTAL', 'label': 'Nonresponders to previous antiviral combination therapy', 'description': 'Nonresponders defined by viral status at weeks 4,12, and 24 of previous peginterferon/ribavirin combination therapy', 'interventionNames': ['Drug: Silibinin']}], 'interventions': [{'name': 'Silibinin', 'type': 'DRUG', 'otherNames': ['Silibinin infusions (20 mg/kg/d infused over 2 hours)given for 21 (either Monday -Friday or daily) or 28 days, continuation of antiviral combination therapy'], 'description': 'comparison of different dosing schedule of Silibinin infusions (20 mg/kg/d infused over 2 hours) A: 3x5days B: 14 days C: 21 days D: 28 days\n\nsequential the infusion duration will be shortened - 2 hours, then 1 hr and then 1/2 hr/infusion', 'armGroupLabels': ['Nonresponders to previous antiviral combination therapy']}, {'name': 'Silibinin', 'type': 'DRUG', 'description': '20 mg/kg Silibinin iv /d /21 days, antiviral combination therapy will be continued', 'armGroupLabels': ['on treatment nonresponders']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. of Medicine', 'investigatorFullName': 'Peter Ferenci', 'investigatorAffiliation': 'Medical University of Vienna'}}}}