Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT00940420
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2009-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2695}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2009-07-06', 'studyFirstSubmitQcDate': '2009-07-15', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety and tolerability with regard to clinical AEs and laboratory parameters', 'timeFrame': 'assessed every 2 weeks throughout study and after 8 weeks follow-up'}], 'secondaryOutcomes': [{'measure': 'safety with regard to hematological parameters', 'timeFrame': 'assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients \\>/= 18 years of age\n* serologic evidence of chronic hepatitis C infection\n* compensated liver disease\n* negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment\n\nExclusion Criteria:\n\n* history or other evidence of a medical condition associated with chronic liver disease other than HCV\n* hepatitis A, hepatitis B or HIV infection\n* hepatocellular carcinoma\n* severe concomitant disease'}, 'identificationModule': {'nctId': 'NCT00940420', 'briefTitle': 'A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C', 'orgStudyIdInfo': {'id': 'ML16837'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: Copegus (ribavirin)', 'Drug: peginterferon alfa-2a [Pegasys]']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: Copegus (ribavirin)', 'Drug: peginterferon alfa-2a [Pegasys]']}], 'interventions': [{'name': 'Copegus (ribavirin)', 'type': 'DRUG', 'description': '800 - 1200 mg po daily for 24 weeks', 'armGroupLabels': ['A']}, {'name': 'Copegus (ribavirin)', 'type': 'DRUG', 'description': '800 - 1200 mg po daily for 48 weeks', 'armGroupLabels': ['B']}, {'name': 'peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': '180 mcg sc once weekly for 24 weeks', 'armGroupLabels': ['A']}, {'name': 'peginterferon alfa-2a [Pegasys]', 'type': 'DRUG', 'description': '180 mcg sc once weekly for 48 weeks', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'zip': '78278', 'city': 'Ashkelon', 'country': 'Israel', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'city': 'Bat Yam', 'country': 'Israel', 'geoPoint': {'lat': 32.02379, 'lon': 34.75185}}, {'zip': '84105', 'city': 'Beersheba', 'country': 'Israel', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '33394', 'city': 'Haifa', 'country': 'Israel', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '34362', 'city': 'Haifa', 'country': 'Israel', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '58100', 'city': 'Holon', 'country': 'Israel', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '22100', 'city': 'Nahariya', 'country': 'Israel', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}, {'city': 'Nazareth', 'country': 'Israel', 'geoPoint': {'lat': 32.70087, 'lon': 35.29719}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Petah Tikva', 'country': 'Israel', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '76100', 'city': 'Rehovot', 'country': 'Israel', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '13110', 'city': 'Safed', 'country': 'Israel', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '6093000', 'city': 'Ẕerifin', 'country': 'Israel', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}