Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-29 @ 3:08 PM
Study NCT ID:
NCT01466192
Status:
COMPLETED
Last Update Posted:
2014-11-03
First Post:
2011-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients
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': 'D012254', 'term': 'Ribavirin'}, {'id': 'C417083', 'term': 'peginterferon alfa-2b'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cti-inq-ml@ml.mt-pharma.co.jp', 'title': 'Clinical Trials, Information Desk', 'organization': 'Mitsubishi Tanabe Pharma Corporation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'MP-424', 'description': 'MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks\n\nRibavirin: 400 - 1000 mg/day based on body weight for 24 weeks\n\nPeginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks', 'otherNumAtRisk': 108, 'otherNumAffected': 108, 'seriousNumAtRisk': 108, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 42}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 86}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 54}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 28}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 25}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 43}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 42}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 33}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 86}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 71}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 30}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 24}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 7}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 6}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 68}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 61}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 40}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 39}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyaluronic acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 23}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 18}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 17}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 9}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 9}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 8}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 6}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 6}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MP-424', 'description': 'MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks\n\nRibavirin: 400 - 1000 mg/day based on body weight for 24 weeks\n\nPeginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '80.3', 'upperLimit': '93.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 24 weeks of follow-up', 'unitOfMeasure': 'percentage of subjects achieving SVR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MP-424', 'description': 'MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks\n\nRibavirin: 400 - 1000 mg/day based on body weight for 24 weeks\n\nPeginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MP-424', 'description': 'MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks\n\nRibavirin: 400 - 1000 mg/day based on body weight for 24 weeks\n\nPeginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '8.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-29', 'studyFirstSubmitDate': '2011-11-02', 'resultsFirstSubmitDate': '2014-10-29', 'studyFirstSubmitQcDate': '2011-11-04', 'lastUpdatePostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-29', 'studyFirstPostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)', 'timeFrame': 'After 24 weeks of follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Genotype 2'], 'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '25196718', 'type': 'RESULT', 'citation': 'Kumada H, Sato K, Takehara T, Nakamuta M, Ishigami M, Chayama K, Toyota J, Suzuki F, Nakayasu Y, Ochi M, Yamada I, Okanoue T. Efficacy of telaprevir-based therapy for difficult-to-treat patients with genotype 2 chronic hepatitis C in Japan. Hepatol Res. 2015 Jul;45(7):745-54. doi: 10.1111/hepr.12416. Epub 2014 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Genotype 2, chronic hepatitis C\n* Relapsers (patient who relapsed after previous treatment)\n* Able and willing to follow contraception requirements\n\nExclusion Criteria:\n\n* Cirrhosis of the liver or hepatic failure\n* Hepatitis B surface antigen-positive or HIV antibodies-positive\n* History of, or concurrent hepatocellular carcinoma\n* History of, or concurrent depression, schizophrenia,; or suicide attempt in the past\n* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant'}, 'identificationModule': {'nctId': 'NCT01466192', 'briefTitle': 'Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin in Subjects With Genotype 2 Hepatitis C, Who Relapsed After Previous Treatment', 'orgStudyIdInfo': {'id': 'G060-A10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MP-424', 'interventionNames': ['Drug: MP-424 (generic name:Telaprevir)', 'Drug: Ribavirin', 'Drug: Peginterferon alfa-2b']}], 'interventions': [{'name': 'MP-424 (generic name:Telaprevir)', 'type': 'DRUG', 'description': '750mg q8h for 12 weeks', 'armGroupLabels': ['MP-424']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': '400 - 1000 mg/day based on body weight for 24 weeks', 'armGroupLabels': ['MP-424']}, {'name': 'Peginterferon alfa-2b', 'type': 'DRUG', 'description': '1.5mcg/kg/week for 24 weeks', 'armGroupLabels': ['MP-424']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Toranomon Hospital'}], 'overallOfficials': [{'name': 'Kazuoki Kondo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}