Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-29 @ 9:32 PM
Study NCT ID:
NCT00723632
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2008-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Czechia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'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', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Serious adverse events and non-serious adverse events were not required to be captured as part of the study database, and were reported directly to the Sponsor. Therefore, no adverse events were collected, and the number at risk is zero.', 'eventGroups': [{'id': 'EG000', 'title': 'Peginterferon Alfa-2b and Ribavirin', 'description': 'Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants \\<65 kg, 1000 mg/day for participants \\>65 to \\<85 kg, and 1200 mg/day for participants \\>=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2b and Ribavirin', 'description': 'Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants \\<65 kg, 1000 mg/day for participants \\>65 to \\<85 kg, and 1200 mg/day for participants \\>=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.'}], 'classes': [{'title': '<= 64 kg (n=182)', 'categories': [{'measurements': [{'value': '28,271', 'groupId': 'OG000', 'lowerLimit': '24,461', 'upperLimit': '33,676'}]}]}, {'title': '65-85 kg (n=334)', 'categories': [{'measurements': [{'value': '31,429', 'groupId': 'OG000', 'lowerLimit': '27,027', 'upperLimit': '36,989'}]}]}, {'title': '>= 85 kg (n=182)', 'categories': [{'measurements': [{'value': '34,782', 'groupId': 'OG000', 'lowerLimit': '29,243', 'upperLimit': '42,261'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3', 'description': 'SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.', 'unitOfMeasure': 'Czech Crown', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.'}, {'type': 'SECONDARY', 'title': 'Average Cost Per Participant With SVR Stratified by Ribavirin Dosage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2b and Ribavirin', 'description': 'Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants \\<65 kg, 1000 mg/day for participants \\>65 to \\<85 kg, and 1200 mg/day for participants \\>=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.'}], 'classes': [{'title': '800 mg/day (n=167)', 'categories': [{'measurements': [{'value': '31,119', 'groupId': 'OG000', 'lowerLimit': '24,658', 'upperLimit': '39,587'}]}]}, {'title': '1000 mg/day (n=333)', 'categories': [{'measurements': [{'value': '29,306', 'groupId': 'OG000', 'lowerLimit': '26,047', 'upperLimit': '33,388'}]}]}, {'title': '1200 mg/day (n=198)', 'categories': [{'measurements': [{'value': '35,621', 'groupId': 'OG000', 'lowerLimit': '30,233', 'upperLimit': '43,274'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3', 'description': 'SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.', 'unitOfMeasure': 'Czech Crown', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.'}, {'type': 'SECONDARY', 'title': 'Average Cost Per Participant With SVR Stratified by Prior Treatment Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peginterferon Alfa-2b and Ribavirin', 'description': 'Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants \\<65 kg, 1000 mg/day for participants \\>65 to \\<85 kg, and 1200 mg/day for participants \\>=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.'}], 'classes': [{'title': 'Treatment-Naive (n=543)', 'categories': [{'measurements': [{'value': '30,109', 'groupId': 'OG000', 'lowerLimit': '27,180', 'upperLimit': '33,580'}]}]}, {'title': 'Previously Treated (n=155)', 'categories': [{'measurements': [{'value': '37,486', 'groupId': 'OG000', 'lowerLimit': '29,938', 'upperLimit': '48,682'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3', 'description': 'SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.', 'unitOfMeasure': 'Czech Crown', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peginterferon Alfa-2b and Ribavirin', 'description': 'Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants \\<65 kg, 1000 mg/day for participants \\>65 to \\<85 kg, and 1200 mg/day for participants \\>=85 kg. Treatment was administered for 48 weeks to participants with hepatitis C virus (HCV) genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '901'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed initial exam form and \\>= 1 follow up visit form; end of treatment and SVR status recorded', 'groupId': 'FG000', 'numSubjects': '698'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '698', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Peginterferon Alfa-2b and Ribavirin', 'description': 'Participants received peginterferon alfa-2b administered subcutaneously 1.5 μg/kg weekly and ribavirin administered orally at 800 mg/day for participants \\<65 kg, 1000 mg/day for participants \\>65 to \\<85 kg, and 1200 mg/day for participants \\>=85 kg. Treatment was administered for 48 weeks to participants with HCV genotype 1 or for 24 weeks to participants with HCV genotype 2, 3.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'description': 'Age is reported for participants in the analysis population', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '300', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '398', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender is reported for participants in the analysis population', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 901}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-01', 'studyFirstSubmitDate': '2008-07-25', 'resultsFirstSubmitDate': '2011-11-11', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-11', 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category', 'timeFrame': 'From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3', 'description': 'SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.'}], 'secondaryOutcomes': [{'measure': 'Average Cost Per Participant With SVR Stratified by Ribavirin Dosage', 'timeFrame': 'From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3', 'description': 'SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.'}, {'measure': 'Average Cost Per Participant With SVR Stratified by Prior Treatment Status', 'timeFrame': 'From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3', 'description': 'SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the costs associated with peginterferon alfa-2b (PegIntron) plus ribavirin (Rebetol) treatment for chronic hepatitis C in the Czech Republic. Only costs associated with rescue medication, concomitant therapy, disease monitoring, and medical intervention costs recognized by the treating institution as treatment-related expenses will be included in the analysis. The study will also evaluate the correlation between hepatitis C virus (HCV) therapy-related costs with ribavirin dosing and participant history.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with chronic hepatitis C treated with peginterferon alfa-2b and ribavirin at approximately 81 sites in the Czech Republic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with chronic hepatitis C\n* At least 18 years old\n* Eligibility determined based on the diagnosis and medical judgment only.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00723632', 'briefTitle': 'Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Cost of Treatment of Chronic Hepatitis C Using Combination of Peginterferon α-2b Plus Ribavirin', 'orgStudyIdInfo': {'id': 'P04588'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peginterferon alfa-2b and ribavirin', 'description': 'All participants included in the study', 'interventionNames': ['Biological: peginterferon alfa-2b', 'Drug: ribavirin']}], 'interventions': [{'name': 'peginterferon alfa-2b', 'type': 'BIOLOGICAL', 'otherNames': ['SCH 054031', 'PegIntron', 'peginterferon α-2b'], 'description': 'Peginterferon alfa-2b administered in accordance with approved labeling, ie, 1.5 μg/kg weekly SC for 48 weeks for participants with hepatitis C virus (HCV) genotype 1 or for 24 weeks for participants with HCV genotype 2, 3.', 'armGroupLabels': ['Peginterferon alfa-2b and ribavirin']}, {'name': 'ribavirin', 'type': 'DRUG', 'otherNames': ['SCH 018908', 'Rebetol'], 'description': 'Ribavirin administered in accordance with approved labeling, ie, 800 mg/day for participants \\<65 kg, 1000 mg/day for participants \\>65 to \\<85 kg, and 1200 mg/day for participants \\>=85 kg, administered orally for 48 weeks for participants with HCV genotype 1 or for 24 weeks for participants with HCV genotype 2, 3.', 'armGroupLabels': ['Peginterferon alfa-2b and ribavirin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}