Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-28 @ 6:41 AM
Study NCT ID:
NCT00727259
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2008-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067)
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': 'Any publication or communication (written or oral) could be performed by the Principal Investigator only after written approval from Schering-Plough.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Per protocol, non-serious adverse events and serious adverse events were not required to be captured as part of the study database, therefore, none were collected, and the number at risk is zero.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients With Chronic Hepatitis C', 'description': 'Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '940', 'groupId': 'OG000'}, {'value': '940', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'After 1 Month of Treatment', 'description': 'Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.'}, {'id': 'OG001', 'title': 'After 3 Months of Treatment', 'description': 'Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.'}], 'classes': [{'title': 'Ease of preparation of the Pen', 'categories': [{'measurements': [{'value': '5.48', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '5.91', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Simplicity of adjustment of the injected dose', 'categories': [{'measurements': [{'value': '5.74', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '6.08', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Time required for the preparation of the injection', 'categories': [{'measurements': [{'value': '5.49', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '5.84', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Ease of injection', 'categories': [{'measurements': [{'value': '5.89', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '6.00', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Characteristics of the needle', 'categories': [{'measurements': [{'value': '6.14', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '6.25', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'Overall satisfaction with the system of injection', 'categories': [{'measurements': [{'value': '5.99', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '6.04', 'spread': '1.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment.', 'description': 'Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).', 'unitOfMeasure': 'satisfaction rating from 0-7', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Both patient questionnaires were returned by 940 subjects. However, some items were not rated on the returned questionnaires. The missing data for questionnaire items range from 24 subjects to 72 subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Chronic Hepatitis C', 'description': 'Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1995'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '940'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1055'}]}], 'dropWithdraws': [{'type': 'Not all questionnaires completed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1055'}]}]}], 'preAssignmentDetails': 'Enrolled: 1995 subjects; all questionnaires were returned for 940 subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '940', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Chronic Hepatitis C', 'description': 'Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol. Results presented concern only participants with all questionnaires returned (940).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.50', 'spread': '12.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '323', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '616', 'groupId': 'BG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '940', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1995}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-07', 'studyFirstSubmitDate': '2008-07-30', 'resultsFirstSubmitDate': '2009-06-18', 'studyFirstSubmitQcDate': '2008-07-30', 'lastUpdatePostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-06-18', 'studyFirstPostDateStruct': {'date': '2008-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months', 'timeFrame': 'The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment.', 'description': 'Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'The current gold standard for treatment of chronic hepatitis C (CHC) patients is with pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegPen. The goal of this study is to determine the satisfaction grade with this novel device.', 'detailedDescription': 'Enrollment of patients will occur in a sequential order of treatment initiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol at sites in France.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients with hepatitis C\n\nExclusion Criteria:\n\n* According to the products' labeling."}, 'identificationModule': {'nctId': 'NCT00727259', 'acronym': 'SATISFACTION', 'briefTitle': 'Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C', 'orgStudyIdInfo': {'id': 'P04067'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with chronic hepatitis C', 'description': 'Adult patients with chronic hepatitis C treated with PegIntron pen/Rebetol.', 'interventionNames': ['Biological: Peginterferon alfa-2b (SCH 54031)', 'Drug: Ribavirin (SCH 18908)']}], 'interventions': [{'name': 'Peginterferon alfa-2b (SCH 54031)', 'type': 'BIOLOGICAL', 'otherNames': ['PegIntron', 'PegPen'], 'description': "Peginterferon alfa-2b will be administered according to the products' labeling.", 'armGroupLabels': ['Patients with chronic hepatitis C']}, {'name': 'Ribavirin (SCH 18908)', 'type': 'DRUG', 'otherNames': ['Rebetol'], 'description': "Ribavirin will be administered according to the products' labeling.", 'armGroupLabels': ['Patients with chronic hepatitis C']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}