Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-04-24 @ 4:52 PM
Study NCT ID:
NCT02993250
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2016-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive
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': 'C000629483', 'term': 'adafosbuvir'}, {'id': 'C000629482', 'term': 'odalasvir'}, {'id': 'D000069616', 'term': 'Simeprevir'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Clinical Leader', 'organization': 'Janssen Pharmaceutical K.K., Japan'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'As the sponsor decided to discontinue the development of JNJ-64294178, the study enrollment to reach the target number of participants was not completed in Cohort 2.'}}, 'adverseEventsModule': {'timeFrame': 'Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)', 'description': 'Safety analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\\].', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: Chronic Hepatitis C Without Cirrhosis', 'description': 'Participants received AL-335 800 milligram (mg) (2\\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 15, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis', 'description': 'Participants received AL-335 800 mg (2\\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Atrioventricular Block First Degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Supraventricular Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Eye Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Gastrointestinal Motility Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Blood Cholesterol Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}], 'seriousEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Chronic Hepatitis C Without Cirrhosis', 'description': 'Participants received AL-335 800 milligram (mg) (2\\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis', 'description': 'Participants received AL-335 800 mg (2\\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)', 'description': 'An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all enrolled participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Chronic Hepatitis C Without Cirrhosis', 'description': 'Participants received AL-335 800 milligram (mg) (2\\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis', 'description': 'Participants received AL-335 800 mg (2\\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '84.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '71.5', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 (follow-up phase)', 'description': 'SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \\[IU/mL\\]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Chronic Hepatitis C Without Cirrhosis', 'description': 'Participants received AL-335 800 milligram (mg) (2\\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis', 'description': 'Participants received AL-335 800 mg (2\\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '84.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '71.5', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 (follow-up phase)', 'description': 'SVR12 was defined as HCV RNA \\< LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Chronic Hepatitis C Without Cirrhosis', 'description': 'Participants received AL-335 800 milligram (mg) (2\\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis', 'description': 'Participants received AL-335 800 mg (2\\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '84.6', 'upperLimit': '100'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '58.7', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 (follow-up phase)', 'description': 'SVR 24 was defined as HCV RNA \\< LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Viral Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Chronic Hepatitis C Without Cirrhosis', 'description': 'Participants received AL-335 800 milligram (mg) (2\\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis', 'description': 'Participants received AL-335 800 mg (2\\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment up to Week 24 (follow up phase)', 'description': 'Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA \\< LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (\\>=) LLOQ during follow-up.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)\\] and had at least 1 postbaseline efficacy measurement in this study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With On-treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Chronic Hepatitis C Without Cirrhosis', 'description': 'Participants received AL-335 800 milligram (mg) (2\\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis', 'description': 'Participants received AL-335 800 mg (2\\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EOT up to Week 12 (follow up phase)', 'description': 'On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA \\>= LLOQ (15 IU/mL) at the actual EOT.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With On-treatment Virologic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Chronic Hepatitis C Without Cirrhosis', 'description': 'Participants received AL-335 800 milligram (mg) (2\\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis', 'description': 'Participants received AL-335 800 mg (2\\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.'}], 'classes': [{'title': 'Day 2: < 15 IU/mL not detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 3: < 15 IU/mL not detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 1: < 15 IU/mL not detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: < 15 IU/mL not detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 3: < 15 IU/mL not detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '63.6', 'groupId': 'OG001'}]}]}, {'title': 'week 4: < 15 IU/mL not detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000'}, {'value': '72.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: < 15 IU/mL not detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: < 15 IU/mL not detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 10: < 15 IU/mL not detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: < 15 IU/mL not detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)', 'description': 'Percentage of participants with On-treatment Virologic Response with HCV RNA \\< LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Chronic Hepatitis C Without Cirrhosis', 'description': 'Participants received AL-335 800 milligram (mg) (2\\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.'}, {'id': 'OG001', 'title': 'Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis', 'description': 'Participants received AL-335 800 mg (2\\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '18.6', 'spread': '3.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'EOT up to Week 24 (follow up phase)', 'description': 'Time to Achieve HCV RNA not Detected or HCV RNA \\<LLOQ (15 IU/mL) was reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Chronic Hepatitis C Without Cirrhosis', 'description': 'Participants received AL-335 800 milligram (mg) (2\\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.'}, {'id': 'FG001', 'title': 'Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis', 'description': 'Participants received AL-335 800 mg (2\\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Chronic Hepatitis C Without Cirrhosis', 'description': 'Participants received AL-335 800 milligram (mg) (2\\*400) tablets, odalasvir (ODV) 25 mg tablet and simeprevir (SMV) 75 mg capsule once daily orally for 8 weeks.'}, {'id': 'BG001', 'title': 'Cohort 2: Chronic Hepatitis C With Compensated Cirrhosis', 'description': 'Participants received AL-335 800 mg (2\\*400) tablets, ODV 25 mg tablet and SMV 75 mg capsule once daily orally for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '54.9', 'spread': '6.76', 'groupId': 'BG001'}, {'value': '57.8', 'spread': '9.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-08', 'size': 864113, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-03T07:32', 'hasProtocol': False}, {'date': '2017-07-27', 'size': 1265658, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-09-10T05:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2016-12-13', 'resultsFirstSubmitDate': '2019-05-03', 'studyFirstSubmitQcDate': '2016-12-13', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-10', 'studyFirstPostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)', 'description': 'An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment', 'timeFrame': 'Week 4 (follow-up phase)', 'description': 'SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \\[IU/mL\\]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).'}, {'measure': 'Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment', 'timeFrame': 'Week 12 (follow-up phase)', 'description': 'SVR12 was defined as HCV RNA \\< LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.'}, {'measure': 'Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment', 'timeFrame': 'Week 24 (follow-up phase)', 'description': 'SVR 24 was defined as HCV RNA \\< LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.'}, {'measure': 'Percentage of Participants With Viral Relapse', 'timeFrame': 'End of treatment up to Week 24 (follow up phase)', 'description': 'Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA \\< LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (\\>=) LLOQ during follow-up.'}, {'measure': 'Percentage of Participants With On-treatment Failure', 'timeFrame': 'EOT up to Week 12 (follow up phase)', 'description': 'On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA \\>= LLOQ (15 IU/mL) at the actual EOT.'}, {'measure': 'Percentage of Participants With On-treatment Virologic Response', 'timeFrame': 'Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)', 'description': 'Percentage of participants with On-treatment Virologic Response with HCV RNA \\< LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.'}, {'measure': 'Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ', 'timeFrame': 'EOT up to Week 24 (follow up phase)', 'description': 'Time to Achieve HCV RNA not Detected or HCV RNA \\<LLOQ (15 IU/mL) was reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis and for 12 weeks in direct-acting antiviral (DAA)-naive Japanese participants with genotype 1 or 2 chronic HCV infection with compensated cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic hepatitis C virus (HCV) infection\n* All participants must have HCV genotype 1 or 2 infection, determined at screening\n* HCV ribonucleic acid (RNA) plasma levels greater than or equal to (\\>=)10,000 international units per Milliliter (IU/mL), determined at screening\n* Direct-acting antiviral (DAA)-naive participants, defined as not having received treatment with any approved or investigational DAA drug for chronic HCV infection; prior HCV therapy consisting of interferon (IFN, pegylated or nonpegylated) with or without ribavirin (RBV) is allowed\n* Participants without cirrhosis or with compensated cirrhosis\n\nExclusion Criteria:\n\n* Infection with HCV genotype - 3, 4, 5, or 6\n* Co-infection with human immunodeficiency virus (HIV 1 or HIV 2 antibody positive) or hepatitis B virus (HBV) (hepatitis B surface antigen \\[HBsAg\\] positive)\n* Prior treatment with any investigational or approved HCV DAA, either in combination with PegIFN or IFN free\n* Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A infection (immunoglobulin M), drug or alcohol related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha 1 antitrypsin deficiency, primary biliary cirrhosis, or any other non-HCV liver disease that is considered clinically significant by the investigator\n* Evidence of hepatic decompensation as assessed with Child-Pugh Class B or C or any of the following: history or current clinical evidence of ascites, bleeding varices, or hepatic encephalopathy"}, 'identificationModule': {'nctId': 'NCT02993250', 'briefTitle': 'A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Pharmaceutical K.K.'}, 'officialTitle': 'A Phase 2a, Multicenter, Open-label Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Subjects With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naïve', 'orgStudyIdInfo': {'id': 'CR108264'}, 'secondaryIdInfos': [{'id': '64294178HPC2003', 'type': 'OTHER', 'domain': 'Janssen Pharmaceutical K.K., Japan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 (Chronic Hepatitis C Without Cirrhosis)', 'description': 'Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.', 'interventionNames': ['Drug: AL-335', 'Drug: Odalasvir (ODV)', 'Drug: Simeprevir (SMV)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)', 'description': 'Participants will receive AL-335 800 milligram (mg)+ODV 25 mg+SMV 75 mg once daily for 12 weeks in Cohort 2. Dosing in cohort 2 will be started according to decision of Data Review Committee (DRC).', 'interventionNames': ['Drug: AL-335', 'Drug: Odalasvir (ODV)', 'Drug: Simeprevir (SMV)']}], 'interventions': [{'name': 'AL-335', 'type': 'DRUG', 'otherNames': ['JNJ-64146212'], 'description': 'Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.', 'armGroupLabels': ['Cohort 1 (Chronic Hepatitis C Without Cirrhosis)', 'Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)']}, {'name': 'Odalasvir (ODV)', 'type': 'DRUG', 'otherNames': ['JNJ-64289901'], 'description': 'Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.', 'armGroupLabels': ['Cohort 1 (Chronic Hepatitis C Without Cirrhosis)', 'Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)']}, {'name': 'Simeprevir (SMV)', 'type': 'DRUG', 'otherNames': ['TMC435'], 'description': 'Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.', 'armGroupLabels': ['Cohort 1 (Chronic Hepatitis C Without Cirrhosis)', 'Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amagasaki-shi', 'country': 'Japan'}, {'city': 'Bunkyō City', 'country': 'Japan', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}, {'city': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Kagoshima', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kurume-shi', 'country': 'Japan'}, {'city': 'Musashino-shi', 'country': 'Japan'}, {'city': 'Nagoya', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Omura-shi', 'country': 'Japan'}, {'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Sakaishi', 'country': 'Japan', 'geoPoint': {'lat': 33.41239, 'lon': 132.71218}}, {'city': 'Sapporo', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Suita-shi', 'country': 'Japan'}, {'city': 'Yokohama', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'overallOfficials': [{'name': 'Janssen Pharmaceutical K.K., Japan Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Pharmaceutical K.K.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Pharmaceutical K.K.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}