Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT00412334
Status:
COMPLETED
Last Update Posted:
2016-04-05
First Post:
2006-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'D012254', 'term': 'Ribavirin'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-02', 'studyFirstSubmitDate': '2006-12-15', 'studyFirstSubmitQcDate': '2006-12-15', 'lastUpdatePostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained viral response', 'timeFrame': 'Week 72'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with >=2log drop of HCV-RNA', 'timeFrame': 'Week 4, 12, 24.'}, {'measure': 'Percentage of patients with non-detectable HCV-RNA', 'timeFrame': 'Week 48'}, {'measure': 'Relapse rate', 'timeFrame': 'Throughout study.'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '21439960', 'type': 'DERIVED', 'citation': 'Chevaliez S, Hezode C, Soulier A, Costes B, Bouvier-Alias M, Rouanet S, Foucher J, Bronowicki JP, Tran A, Rosa I, Mathurin P, Alric L, Leroy V, Couzigou P, Mallat A, Charaf-Eddine M, Babany G, Pawlotsky JM. High-dose pegylated interferon-alpha and ribavirin in nonresponder hepatitis C patients and relationship with IL-28B genotype (SYREN trial). Gastroenterology. 2011 Jul;141(1):119-27. doi: 10.1053/j.gastro.2011.03.039. Epub 2011 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients \\>=18 years of age, with CHC genotype 1;\n* patients who have failed to respond to previous treatment with PEGASYS plus ribavirin for \\>=12 weeks;\n* patients who have discontinued PEGASYS/ribavirin \\>=4 weeks prior to enrollment;\n* compensated liver disease.\n\nExclusion Criteria:\n\n* other forms of liver disease;\n* infection with HIV, HAV, HBV;\n* hepatocellular cancer.'}, 'identificationModule': {'nctId': 'NCT00412334', 'briefTitle': 'SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Antiviral Effect of 4 Regimens of PEGASYS Plus Copegus in Patients With Genotype 1 Chronic Hepatitis C Non-responder to Previous Peginterferon Alfa-2a Plus Ribavirin Therapy', 'orgStudyIdInfo': {'id': 'ML20399'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Copegus', 'Drug: peginterferon alfa-2a [Pegasys]']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Copegus', 'Drug: peginterferon alfa-2a [Pegasys]']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: Copegus', 'Drug: peginterferon alfa-2a [Pegasys]']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Drug: Copegus', 'Drug: peginterferon alfa-2a [Pegasys]']}], 'interventions': [{'name': 'Copegus', 'type': 'DRUG', 'description': '1200-1600mg/day po', 'armGroupLabels': ['3', '4']}, {'name': 'Copegus', 'type': 'DRUG', 'description': '1000-1200mg/day po', 'armGroupLabels': ['1', '2']}, {'name': 'peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': '360 micrograms sc weekly', 'armGroupLabels': ['1', '3']}, {'name': 'peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': '180 micrograms sc twice weekly', 'armGroupLabels': ['2', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49033', 'city': 'Angers', 'country': 'France', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '36019', 'city': 'Châteauroux', 'country': 'France', 'geoPoint': {'lat': 46.81248, 'lon': 1.69362}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '83407', 'city': 'Hyères', 'country': 'France', 'geoPoint': {'lat': 43.12038, 'lon': 6.12857}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13285', 'city': 'Marseille', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '57038', 'city': 'Metz', 'country': 'France', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '94804', 'city': 'Villejuif', 'country': 'France', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}