Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT00725751
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2008-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, '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': 'C417083', 'term': 'peginterferon alfa-2b'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'All participants who received at least one dose of study therapy.', 'eventGroups': [{'id': 'EG000', 'title': 'PegIFN-2b/Ribavirin With Substitution Therapy', 'description': 'Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)', 'otherNumAtRisk': 90, 'otherNumAffected': 18, 'seriousNumAtRisk': 90, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'PegIFN-2b/Ribavirin Without Substitution Therapy', 'description': 'Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)', 'otherNumAtRisk': 258, 'otherNumAffected': 35, 'seriousNumAtRisk': 258, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Accidental death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PegIFN-2b/Ribavirin With Substitution Therapy', 'description': 'Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)'}, {'id': 'OG001', 'title': 'PegIFN-2b/Ribavirin Without Substitution Therapy', 'description': 'Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 to 48 weeks', 'description': 'For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of PegIFN-2b/ribavirin'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Sustained Virologic Response (SVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PegIFN-2b/Ribavirin With Substitution Therapy', 'description': 'Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)'}, {'id': 'OG001', 'title': 'PegIFN-2b/Ribavirin Without Substitution Therapy', 'description': 'Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)', 'description': 'SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants who received at least one dose of antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)\n\nParticipants who received at least one dose of antiviral treatment and did not receive substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of antiviral treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PegIFN-2b/Ribavirin With Substitution Therapy', 'description': 'Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)'}, {'id': 'FG001', 'title': 'PegIFN-2b/Ribavirin Without Substitution Therapy', 'description': 'Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '258'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '108'}]}]}], 'preAssignmentDetails': '353 participants were enrolled on the study; 348 were treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PegIFN-2b/Ribavirin With Substitution Therapy', 'description': 'Participants in this group received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)'}, {'id': 'BG001', 'title': 'PegIFN-2b/Ribavirin Without Substitution Therapy', 'description': 'Participants in this group received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.38', 'spread': '9.51', 'groupId': 'BG000'}, {'value': '42.26', 'spread': '12.62', 'groupId': 'BG001'}, {'value': '39.71', 'spread': '12.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 353}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2008-07-25', 'resultsFirstSubmitDate': '2012-03-23', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-23', 'studyFirstPostDateStruct': {'date': '2008-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin', 'timeFrame': '24 to 48 weeks', 'description': 'For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Achieved Sustained Virologic Response (SVR)', 'timeFrame': '24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)', 'description': 'SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.'}, {'measure': 'Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy', 'timeFrame': 'Day 1', 'description': 'This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients receiving treatment for hepatitis C with/without substitution therapy at sites in Austria.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients with hepatitis C\n\nExclusion Criteria:\n\n* According to the products' European labeling"}, 'identificationModule': {'nctId': 'NCT00725751', 'briefTitle': 'Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Evaluation of Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Patients With/Without Substitution Therapy in Austria', 'orgStudyIdInfo': {'id': 'P05255'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PegIFN-2b/ribavirin with substitution therapy', 'description': 'Participants in this cohort received antiviral treatment and substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)', 'interventionNames': ['Biological: Pegylated interferon alfa-2b (PegIFN-2b)', 'Drug: Ribavirin']}, {'label': 'PegIFN-2b/ribavirin without substitution therapy', 'description': 'Participants in this cohort received antiviral treatment but did not receive substitution therapy (opioid medicines with long-lasting effects \\[methadone + buprenorphine\\] or morphine)', 'interventionNames': ['Biological: Pegylated interferon alfa-2b (PegIFN-2b)', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Pegylated interferon alfa-2b (PegIFN-2b)', 'type': 'BIOLOGICAL', 'otherNames': ['PegIntron', 'SCH 54031'], 'description': 'PegIFN-2b administered according to European labeling.', 'armGroupLabels': ['PegIFN-2b/ribavirin with substitution therapy', 'PegIFN-2b/ribavirin without substitution therapy']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Rebetol', 'SCH 18908'], 'description': 'Ribavirin administered according to European labeling.', 'armGroupLabels': ['PegIFN-2b/ribavirin with substitution therapy', 'PegIFN-2b/ribavirin without substitution therapy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}