Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-29 @ 7:57 PM
Study NCT ID:
NCT03144635
Status:
COMPLETED
Last Update Posted:
2019-06-03
First Post:
2017-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C578009', 'term': 'grazoprevir'}, {'id': 'C000589335', 'term': 'elbasvir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eogawa@gim.med.kyushu-u.ac.jp', 'phone': '81926425909', 'title': 'Dr. Eiichi Ogawa / Assistant Professor', 'organization': 'Kyushu University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Grazoprevir Plus Elbasvir', 'description': 'Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.\n\nGrazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Serious ALT elevation', 'notes': 'ALT\\>300 U/L during treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Grazoprevir Plus Elbasvir', 'description': 'Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.\n\nGrazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '156', 'spread': '58', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '176', 'spread': '65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'We evaluated the serum endostatin at baseline and 3 months after the treatment initiation.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Grazoprevir Plus Elbasvir', 'description': 'Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.\n\nGrazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '52', 'spread': '8', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '53', 'spread': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'We evaluated eGFR level at baseline and 3 months after the treatment initiation.', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sustained Virological Response-12 (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intention-to-treat Populations', 'description': 'Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.\n\nGrazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.'}, {'id': 'OG001', 'title': 'Per-protocol Populations', 'description': 'Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.\n\nGrazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Three patients discontinued treatment due to adverse effects.'}, {'type': 'SECONDARY', 'title': 'Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Grazoprevir Plus Elbasvir', 'description': 'Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.\n\nGrazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '47', 'spread': '41', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '21', 'spread': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'We evaluated the serum ALT levels at baseline and 3 months after the treatment initiation.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Grazoprevir Plus Elbasvir', 'description': 'Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.\n\nGrazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.7', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '4.6', 'spread': '3.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'We evaluated the serum alpha-fetoprotein levels at baseline and 3 months after the treatment initiation.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Grazoprevir Plus Elbasvir', 'description': 'Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.\n\nGrazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'We identified the NS3/4A or NS5A muttations by direct sequencing at baseline. Among participants who had mutations, we calcualted the rate of SVR12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Grazoprevir Plus Elbasvir', 'description': 'Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.\n\nGrazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Grazoprevir Plus Elbasvir', 'description': 'Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.\n\nGrazoprevir plus Elbasvir: An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000', 'lowerLimit': '69', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'groupId': 'BG000', 'lowerLimit': '20.7', 'upperLimit': '25.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Albumin', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'BG000', 'lowerLimit': '3.6', 'upperLimit': '4.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Aspartate aminotransferase', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Alanine aminotransferase', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Gamma-glutamyl transpeptidase', 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'alpha-fetoprotein', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'BG000', 'lowerLimit': '3.0', 'upperLimit': '12.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Cirrhosis', 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HCV RNA level', 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'BG000', 'lowerLimit': '5.9', 'upperLimit': '6.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'logIU/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Treatment Naive', 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HCV NS5A RAS', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'We identified the following as amino-acid resistance-associated substitutions (RAS) to non-structual 5A (NS5A) inhibitor by direct sequencing: NS5A gene amino acid positions 30, 31, and 93 for patients infected with HCV were examined at baseline.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-20', 'size': 451345, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-18T03:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2017-04-28', 'resultsFirstSubmitDate': '2018-09-21', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-18', 'studyFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months', 'timeFrame': '3 months', 'description': 'We evaluated the serum endostatin at baseline and 3 months after the treatment initiation.'}, {'measure': 'Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months', 'timeFrame': '3 months', 'description': 'We evaluated eGFR level at baseline and 3 months after the treatment initiation.'}], 'secondaryOutcomes': [{'measure': 'Sustained Virological Response-12 (SVR12)', 'timeFrame': '3 months', 'description': 'SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment.'}, {'measure': 'Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months', 'timeFrame': '3 months', 'description': 'We evaluated the serum ALT levels at baseline and 3 months after the treatment initiation.'}, {'measure': 'Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months', 'timeFrame': '3 months', 'description': 'We evaluated the serum alpha-fetoprotein levels at baseline and 3 months after the treatment initiation.'}, {'measure': 'Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12', 'timeFrame': '3 months', 'description': 'We identified the NS3/4A or NS5A muttations by direct sequencing at baseline. Among participants who had mutations, we calcualted the rate of SVR12.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Direct Acting Antivirals', 'Grazoprevir', 'Elbasvir'], 'conditions': ['Hepatitis C Viral', 'Chronic Kidney Disease stage3']}, 'referencesModule': {'references': [{'pmid': '23542346', 'type': 'BACKGROUND', 'citation': 'Furusyo N, Ogawa E, Nakamuta M, Kajiwara E, Nomura H, Dohmen K, Takahashi K, Satoh T, Azuma K, Kawano A, Tanabe Y, Kotoh K, Shimoda S, Hayashi J; Kyushu University Liver Disease Study (KULDS) Group. Telaprevir can be successfully and safely used to treat older patients with genotype 1b chronic hepatitis C. J Hepatol. 2013 Aug;59(2):205-12. doi: 10.1016/j.jhep.2013.03.020. Epub 2013 Mar 28.'}, {'pmid': '27142311', 'type': 'BACKGROUND', 'citation': 'Ogawa E, Furusyo N, Yamashita N, Kawano A, Takahashi K, Dohmen K, Nakamuta M, Satoh T, Nomura H, Azuma K, Koyanagi T, Kotoh K, Shimoda S, Kajiwara E, Hayashi J; Kyushu University Liver Disease Study(KULDS) Group. Effectiveness and safety of daclatasvir plus asunaprevir for patients with hepatitis C virus genotype 1b aged 75 years and over with or without cirrhosis. Hepatol Res. 2017 Mar;47(3):E120-E131. doi: 10.1111/hepr.12738. Epub 2016 Jun 10.'}, {'pmid': '26095167', 'type': 'BACKGROUND', 'citation': 'Ogawa E, Furusyo N, Kajiwara E, Nomura H, Kawano A, Takahashi K, Dohmen K, Satoh T, Azuma K, Nakamuta M, Koyanagi T, Kotoh K, Shimoda S, Hayashi J. Comparative effectiveness and safety study of triple therapy with simeprevir or telaprevir for non-cirrhotic patients with chronic hepatitis C virus genotype 1b infection. J Gastroenterol Hepatol. 2015 Dec;30(12):1759-67. doi: 10.1111/jgh.13016.'}]}, 'descriptionModule': {'briefSummary': 'The regimen using grazoprevir plus elbasvir treatment is promising in Japan, because it may safely be used for the elderly patients with renal dysfunction. Grazoprevir and elbasvir are metabolized in the liver and do not require dose-adjustment for patients with renal dysfunction. However, no data related to efficacy and safety of the grazoprevir plus elbasvir treatment for Japanese elderly patients with renal dysfunction (eGFR\\<60 mL/min/1.73m2) have been reported. Therefore, physicians are at a loss whether or not to treat the patients with renal dysfunction due to no evidence.\n\nThe aim of this study is to investigate the improvement of serum endostatin level of Japanese patients with CKD stage 3 after grazoprevir (NS3/4A protease inhibitor) plus elbasvir (NS5A replication complex inhibitor) treatment by a prospective, multicenter cohort study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects aged 20 years or older.\n2. Patients positive for HCV RNA for over 6 months and infected with genotype 1b chronic hepatitis C, including compensated cirrhosis.\n3. Patients without co-infection of hepatitis B virus.\n4. Patients without co-infection of human immunodeficiency virus\n5. Patients with moderate chronic kidney disease (CKD stage 3) (eGFR: 30-59 mL/min/1.73m2). A diagnosis of CKD is only confirmed if repeated eGFR tests for at least 90 days.\n\nExclusion Criteria:\n\n1. Patients with decompensated cirrhosis (Child Pugh B and C)\n2. Patients with albumin \\<3.0 g/dL and platelets \\<75,000 /μL\n3. Patients with autoimmune hepatitis\n4. Constant heavy alcohol drinkers (converted to ethanol ≥60 g/day)\n5. Patients who have a history of hypersensitivity to grazoprevir and elbasvir\n6. Patients who are pregnant females, or females who may become pregnant, or females who are breastfeeding\n7. Patients with heart disease that is hard to control (e.g., very recent cardiac infarction, severe heart failure, unstable arrhythmia)\n8. Patients who are under medication with drugs listed as contraindication in a package insert of grazoprevir plus elbasvir treatment\n9. Patients judged (by the physician in charge of research) to be inappropriate as subjects for the study for any other reasons.'}, 'identificationModule': {'nctId': 'NCT03144635', 'briefTitle': 'A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir', 'organization': {'class': 'OTHER', 'fullName': 'Kyushu University'}, 'officialTitle': 'A Prospective Multicenter Observational Study for Characterization of Renal Function G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir', 'orgStudyIdInfo': {'id': 'KULDS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Grazoprevir plus Elbasvir', 'description': 'Grazoprevir 100 mg plus Elbasvir 50 mg per day for 12 weeks.', 'interventionNames': ['Drug: Grazoprevir plus Elbasvir']}], 'interventions': [{'name': 'Grazoprevir plus Elbasvir', 'type': 'DRUG', 'description': 'An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.', 'armGroupLabels': ['Grazoprevir plus Elbasvir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '812-8582', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Kyushu University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}], 'overallOfficials': [{'name': 'Norihiro Furusyo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyushu University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyushu University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of General Internal Medicine', 'investigatorFullName': 'Norihiro Furusyo', 'investigatorAffiliation': 'Kyushu University'}}}}