Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-26 @ 9:37 AM
Study NCT ID:
NCT00723892
Status:
COMPLETED
Last Update Posted:
2015-10-30
First Post:
2008-07-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': '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': {'otherDetails': 'Data publishing of the observational study is forbidden. Data and results of the observational study are the exclusive property of the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse events and serious adverse events were based on the number of participants recruited and enrolled (N=614).', 'eventGroups': [{'id': 'EG000', 'title': 'All Enrolled Participants', 'otherNumAtRisk': 614, 'otherNumAffected': 0, 'seriousNumAtRisk': 614, 'seriousNumAffected': 11}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': "Basedow's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Drug Intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchopulmonary Aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Transient Ischemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Persecutory Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dermatitis Exfoliative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 614, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PegIntron/Rebetol and Psychotherapy Support Program', 'description': 'Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.'}, {'id': 'OG001', 'title': 'PegIntron/Rebetol Alone (no Psychotherapy)', 'description': 'Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months after onset of treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.'}, {'type': 'SECONDARY', 'title': 'the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PegIntron/Rebetol and Psychotherapy Support Program', 'description': 'Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.'}, {'id': 'OG001', 'title': 'PegIntron/Rebetol Alone (no Psychotherapy', 'description': 'Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '35.3', 'spread': '17.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months after onset of treatment', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with no missing results.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PegIntron/Rebetol and Psychotherapy Support Program', 'description': 'Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.'}, {'id': 'FG001', 'title': 'PegIntron/Rebetol Alone (no Psychotherapy)', 'description': 'Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '313'}, {'groupId': 'FG001', 'numSubjects': '255'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '168'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '87'}]}], 'dropWithdraws': [{'type': 'Participant not tracked', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'Virological criterion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'End planned', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Bad tolerance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Multiple reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Study end', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Weight loss', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Alcohol abuse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Intercurrent infection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Drug addiction', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '614 participants were recruited in this study.', 'preAssignmentDetails': 'Only 568 participants were assigned to treatment as they were foreseen to complete treatment, were consulted, and met inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '568', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PegIntron/Rebetol and Psychotherapy Support Program', 'description': 'Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.'}, {'id': 'BG001', 'title': 'PegIntron/Rebetol Alone (no Psychotherapy)', 'description': 'Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '48.5', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '46.8', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}]}, {'title': 'Unavailable (missing data)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '313', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '568', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 614}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-29', 'studyFirstSubmitDate': '2008-07-25', 'resultsFirstSubmitDate': '2010-08-25', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-25', 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.', 'timeFrame': '12 months after onset of treatment'}], 'secondaryOutcomes': [{'measure': 'the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol', 'timeFrame': '12 months after onset of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic', 'Hepacivirus']}, 'descriptionModule': {'briefSummary': 'Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.', 'detailedDescription': 'Enrollment of participants will occur in a sequential order of treatment initiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants at sites in France who are receiving a psychotherapy support program during therapy for hepatitis C and a control group without a psychotherapy support program.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients with hepatitis C\n\nExclusion Criteria:\n\n* According to the products' labeling"}, 'identificationModule': {'nctId': 'NCT00723892', 'briefTitle': 'Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Observatory on Treatment Adhesion in Patients Suffering From Hepatitis C Chronic Treated With ViraferonPeg® Injected / Rebetol® in Conjunction With a Psychotherapeutic Assistance Program', 'orgStudyIdInfo': {'id': 'P04252'}, 'secondaryIdInfos': [{'id': 'MK-4031-245', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'PegIntron/Rebetol and psychotherapy support program', 'description': 'Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.', 'interventionNames': ['Biological: Peginterferon alfa-2b (PegIntron)', 'Drug: Rebetol (Ribavirin)', 'Behavioral: Psychotherapy support program']}, {'label': 'PegIntron/Rebetol alone (no psychotherapy)', 'description': 'Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C.', 'interventionNames': ['Biological: Peginterferon alfa-2b (PegIntron)', 'Drug: Rebetol (Ribavirin)']}], 'interventions': [{'name': 'Peginterferon alfa-2b (PegIntron)', 'type': 'BIOLOGICAL', 'otherNames': ['PegIntron pen', 'SCH 54031', 'ViraferonPeg'], 'description': 'Peginterferon alfa-2b (PegIntron) was administered based on the prescribed dose. The average dose for PegIntron was a weekly injection of 1.5 ± 0.3 μg\\^kg\\^week', 'armGroupLabels': ['PegIntron/Rebetol alone (no psychotherapy)', 'PegIntron/Rebetol and psychotherapy support program']}, {'name': 'Rebetol (Ribavirin)', 'type': 'DRUG', 'otherNames': ['Ribavirin', 'SCH 18908'], 'description': 'Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg\\^day', 'armGroupLabels': ['PegIntron/Rebetol alone (no psychotherapy)', 'PegIntron/Rebetol and psychotherapy support program']}, {'name': 'Psychotherapy support program', 'type': 'BEHAVIORAL', 'description': 'Each site has implemented a psychotherapy support program.', 'armGroupLabels': ['PegIntron/Rebetol and psychotherapy support program']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}