Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-29 @ 1:24 AM
Study NCT ID:
NCT00726557
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2008-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D015819', 'term': 'Substance Abuse, Intravenous'}], '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'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Trial results belong to the Sponsor only, all investigators are not allowed to publish trial results without permission of the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Non-serious adverse events (AEs) were not captured as part of the study database. Nevertheless, at the end of each visit, physicians were asked to state if an AE occurred since the last visit. Therefore, it is possible to show only the total number of AEs, which was 104 in the 118 complete participants and 224 in all 246 enrolled participants.', 'eventGroups': [{'id': 'EG000', 'title': 'PegIntron + Rebetol', 'description': 'PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 246, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pregnancy of partner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Negative HCV-RNA at End of Treatment', 'description': 'End of treatment is 24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4'}], 'classes': [{'title': 'Opioid substitution with methadone (n=52)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Opioid substitution with levo-methadone (n=13)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Opioid substitution with buprenorphine (n=26)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Opioid substitution with other medication (n=1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No opioid substitution medication (n=9)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Follow-up (Week 48 or Week 72, depending on genotype)', 'description': 'Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who achieved SVR at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4)'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Who Tolerated Treatment', 'description': 'Those who completed treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed at the end of treatment', 'description': 'Tolerability of the treatment was measured by number of participants with complete treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PegIntron + Rebetol', 'description': 'PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed is defined as those who finished the follow-up period.', 'groupId': 'FG000', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}]}], 'dropWithdraws': [{'type': 'Screening failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'No end of treatment documentation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'No follow-up documentation available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'Treatment less than 3 months', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Inclusion criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PegIntron + Rebetol', 'description': 'Baseline measures only available for the 118 participants who completed.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.64', 'spread': '8.39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}, {'title': 'Unavailable', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '246', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-08', 'studyFirstSubmitDate': '2008-07-30', 'resultsFirstSubmitDate': '2010-04-15', 'studyFirstSubmitQcDate': '2008-07-30', 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-15', 'studyFirstPostDateStruct': {'date': '2008-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions', 'timeFrame': 'End of Follow-up (Week 48 or Week 72, depending on genotype)', 'description': 'Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).'}, {'measure': 'Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week', 'timeFrame': 'Assessed at the end of treatment', 'description': 'Tolerability of the treatment was measured by number of participants with complete treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic', 'Substance Abuse, Intravenous']}, 'descriptionModule': {'briefSummary': 'Previous intravenous drug abusers with chronic hepatitis C who are under substitution therapy (buprenorphine, methadone) will be treated with PegIntron and Rebetol according to the approved European labeling. The study will assess the tolerability, safety and efficacy of the treatment with PegIntron plus Rebetol in this study population. The objective of the study is to collect data on the prevalence of the hepatitis C infections in drug-substituted patients. The study will also compare the feasibility of HCV (Hepatitis C Virus) treatment in patients receiving Subutex® vs other drug substitution pharmacotherapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Previous intravenous drug abusers with chronic hepatitis C receiving substitution therapy (buprenorphine, methadone or other) at approximately 100 sites in Germany.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment-naïve participants or relapsers to interferon monotherapy\n* Participants with chronic hepatitis C infection\n* At least 18 years of age\n* Must meet the following laboratory criteria:\n\n * Platelets \\>=100,000/mm\\^3\n * Neutrophil count \\>=1,500/mm\\^3\n * TSH (thyroid stimulating hormone) within normal limits\n * Hemoglobin \\>=12 g/dL (females); \\>=13 g/dL (males)\n* Ex-intravenous drug abusers who are under stable substitution therapy\n* Women of childbearing potential must practice adequate contraception and have a routine pregnancy test performed monthly during treatment and for 7 months post-treatment.\n* Sexually-active participants must be practicing acceptable methods of contraception during the treatment and for 7 months post-treatment\n\nExclusion Criteria:\n\n* Any contraindications specified in the SPC (Summary of Product Characteristics) and approved European labeling\n* Hypersensitivity to the active substance or to any interferons or to any of the excipients\n* Pregnant women\n* Women who are breast-feeding\n* Existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt\n* A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous 6 months\n* Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance \\<50 mL/min\n* Coinfection with HIV (Human Immunodeficiency Virus)\n* Autoimmune hepatitis or history of autoimmune disease\n* Severe hepatic dysfunction or decompensated cirrhosis of the liver\n* Pre-existing thyroid disease unless it can be controlled with conventional therapy\n* Epilepsy and/or compromised central nervous system function'}, 'identificationModule': {'nctId': 'NCT00726557', 'acronym': 'SUPPORT', 'briefTitle': 'Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Quality Assurance of HCV-therapy With PegIntron® Plus Rebetol® in Drug-substituted Patients - SUPPORT Project Post-Marketing Surveillance Study', 'orgStudyIdInfo': {'id': 'P04408'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PegIntron + Rebetol', 'description': 'There will be a distinction between the patients depending on the type of substitution drug used (secondary parameters).', 'interventionNames': ['Biological: PegIntron (pegylated interferon alfa-2b; SCH 54031)', 'Drug: Rebetol (ribavirin; SCH 18908)']}], 'interventions': [{'name': 'PegIntron (pegylated interferon alfa-2b; SCH 54031)', 'type': 'BIOLOGICAL', 'otherNames': ['SCH 54031'], 'description': 'PegIntron 1.5 μg/kg/week administered for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue PegIntron therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4', 'armGroupLabels': ['PegIntron + Rebetol']}, {'name': 'Rebetol (ribavirin; SCH 18908)', 'type': 'DRUG', 'otherNames': ['SCH 18908'], 'description': 'Rebetol administered at 10.6 mg/kg/day for a minimum of 12 weeks. Patients who achieve early virologic response at Treatment Week 12, will continue Rebetol therapy for a total of 24 weeks for subjects infected with HCV genotype 2 or 3, and for a total of 48 weeks for subjects infected with HCV genotype 1 or 4', 'armGroupLabels': ['PegIntron + Rebetol']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}