Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-02-08 @ 6:43 PM
Study NCT ID:
NCT01378104
Status:
COMPLETED
Last Update Posted:
2013-03-08
First Post:
2011-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)
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': 'C100416', 'term': 'peginterferon alfa-2a'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'doctorkwon@catholic.ac.kr', 'phone': '+82322805886', 'title': 'Dr. Kwon', 'organization': 'the Catholic University of Korea'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '100% Dosage Group of Peginterferon Alfa 2a', 'description': 'These group patients would be treated with standard dose 180 ug/week for 48 weeks.\n\npeginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.\n\nIn general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.', 'otherNumAtRisk': 92, 'otherNumAffected': 45, 'seriousNumAtRisk': 92, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '80% Dosage Group of Peginterferon Alfa 2a', 'description': 'This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.\n\npeginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable', 'otherNumAtRisk': 86, 'otherNumAffected': 49, 'seriousNumAtRisk': 86, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'laboratory adverse events', 'notes': 'Neutropenia, thrombocytopenia, anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 54, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 49, 'numAffected': 49}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CBC'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '100% Dosage Group of Peginterferon Alfa 2a', 'description': 'These group patients would be treated with standard dose 180 ug/week for 48 weeks.\n\npeginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.\n\nIn general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.'}, {'id': 'OG001', 'title': '80% Dosage Group of Peginterferon Alfa 2a', 'description': 'This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.\n\npeginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'post treatment 24 weeks', 'description': 'We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.', 'unitOfMeasure': 'participants who achieved SVR', 'reportingStatus': 'POSTED', 'populationDescription': 'We present the result of intention-to-treat analysis.'}, {'type': 'SECONDARY', 'title': 'IL28B Polymorphism Effect on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Favourable IL28B Genotype', 'description': 'These group patients show the IL28B rs12979860CC and rs8099917TT.'}, {'id': 'OG001', 'title': 'The Patients With Unfavourable IL28B Genotype', 'description': 'These group patients show the IL28B rs12979860 CT or TT and rs8099917 TG or GG.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'post treatment 24 weeks', 'description': 'We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.', 'unitOfMeasure': 'percentage of SVR', 'reportingStatus': 'POSTED', 'populationDescription': 'The patients who agreed to check the genotype were analysed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '100% Dosage Group of Peginterferon Alfa 2a', 'description': 'These group patients would be treated with standard dose 180 ug/week for 48 weeks.\n\npeginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.\n\nIn general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.'}, {'id': 'FG001', 'title': '80% Dosage Group of Peginterferon Alfa 2a', 'description': 'This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.\n\npeginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'recruitmentDetails': 'enrollment date : 2009-2011 recruitment period : 2009-2012 type location: 14 university hospital', 'preAssignmentDetails': 'no excluded patients before assignment to groups'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '100% Dosage Group of Peginterferon Alfa 2a', 'description': 'These group patients would be treated with standard dose 180 ug/week for 48 weeks.\n\npeginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.\n\nIn general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.'}, {'id': 'BG001', 'title': '80% Dosage Group of Peginterferon Alfa 2a', 'description': 'This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.\n\npeginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '48.7', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '48.6', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-03', 'studyFirstSubmitDate': '2011-06-16', 'resultsFirstSubmitDate': '2012-12-14', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-03', 'studyFirstPostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a', 'timeFrame': 'post treatment 24 weeks', 'description': 'We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.'}], 'secondaryOutcomes': [{'measure': 'IL28B Polymorphism Effect on SVR', 'timeFrame': 'post treatment 24 weeks', 'description': 'We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['reducing dose of peginterferon', 'chronic hepatitis c', 'Koreans', 'IL28B polymorphism'], 'conditions': ['Sustained Virologic Response', 'IL28B Polymorphism']}, 'descriptionModule': {'briefSummary': '1. Randomized controlled multicenter study\n2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1\n3. IL28B polymorphism in Koreans with CHC', 'detailedDescription': 'The virologic response of Koreans to combination therapy for chronic hepatitis C is similar to non-Asians; however, dose modification occurs more frequently in Koreans.\n\n-When we evaluated the rates of peginterferon α-2a and ribavirin dose modifications and their effect on the virologic response in Koreans, we suggested that using at least 80% of the peginterferon α-2a dose in Koreans not only maintains SVR but also reduces drug side effects during the entire treatment period and a lower dose of ribavirin may be as efficacious as a standard dose(Korean J Intern Med 2009;24:203-211).\n\nSo we investigate whether the group of 80% use dosage of peginterferon alfa-2a did not show inferior response rather than that of 100 % use dosage group and minimize the adverse events.\n\nThere are recently reports that Koreans have favorable IL28B SNP for CHC treatment.\n\n-We investigate the IL28B polymorphism in Koreans with CHC and this result can effect on the SVR depending on the dosage of peginterferon alfa 2a'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic hepatitis C (anti HCV+, HCV RNA +)\n* Genotype 1\n* over 18 year-old\n* Pregnancy test negative if women of childbearing age\n\nExclusion Criteria:\n\n* pregnant women or breast feeding women\n* systemic chemotherapy or steroid therapy before 6 months of trial\n* Coinfection with HAV, HBV, and HIV\n* Other liver disease such as hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxic hepatitis\n* Hepatocellular carcinoma\n* Evidence of decompensation such as variceal bleeding,ascites, encephalopathy\n* ANC less than 1500, platelet less than 90k\n* Cr more than 1.5 of UNL\n* Severe psychiatric problem\n* Poorly controlled thyroid disease\n* Severe retinopathy'}, 'identificationModule': {'nctId': 'NCT01378104', 'briefTitle': '100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'The Response of Reducing Dose of Peginterferon Alfa-2a in Koreans With Chronic Hepatitis C Genotype 1; Randomized Controlled Multicenter Study 100% Versus 80%', 'orgStudyIdInfo': {'id': 'PEGASYS100:80'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '80% dosage group of peginterferon alfa 2a', 'description': 'This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.', 'interventionNames': ['Drug: peginterferon alfa 2a (pegasys)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '100% dosage group of peginterferon alfa 2a', 'description': 'These group patients would be treated with standard dose 180 ug/week for 48 weeks.', 'interventionNames': ['Drug: peginterferon alfa-2a (pegasys)']}], 'interventions': [{'name': 'peginterferon alfa 2a (pegasys)', 'type': 'DRUG', 'otherNames': ['Roche'], 'description': 'dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable', 'armGroupLabels': ['80% dosage group of peginterferon alfa 2a']}, {'name': 'peginterferon alfa-2a (pegasys)', 'type': 'DRUG', 'otherNames': ['Roche'], 'description': 'These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.', 'armGroupLabels': ['100% dosage group of peginterferon alfa 2a']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soonchunghyang University Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Chunchun', 'country': 'South Korea', 'facility': 'Hallym University Chunchun Medical center'}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejun', 'country': 'South Korea', 'facility': 'Ghungnam National University hospital', 'geoPoint': {'lat': 37.58221, 'lon': 126.74156}}, {'city': 'Daejun', 'country': 'South Korea', 'facility': 'Konyang University hospital', 'geoPoint': {'lat': 37.58221, 'lon': 126.74156}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': "Incheon St. Mary's Hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Koyang-si', 'country': 'South Korea', 'facility': 'Inje University, Ilsan Paik Hospital'}, {'city': 'Koyang-si', 'country': 'South Korea', 'facility': 'NHIC Ilsan hospital'}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Inje University, Pusan Paik Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan university', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Yonsei University, Wonju Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'overallOfficials': [{'name': 'Jung Hyun Kwon, MD, Assistant professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Catholic University of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ulsan University Hospital', 'class': 'OTHER'}, {'name': 'National Health Insurance Service Ilsan Hospital', 'class': 'OTHER'}, {'name': 'Inje University', 'class': 'OTHER'}, {'name': 'Soonchunhyang University Hospital', 'class': 'OTHER'}, {'name': 'Yonsei University', 'class': 'OTHER'}, {'name': 'Chungnam National University', 'class': 'OTHER'}, {'name': 'Keimyung University', 'class': 'OTHER'}, {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, {'name': 'Konyang University Hospital', 'class': 'OTHER'}, {'name': 'Inha University Hospital', 'class': 'OTHER'}, {'name': 'Hallym University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Jung Hyun Kwon', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}