[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100285254":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":40,"centralContacts":44,"locations":45,"responsibleParty":122,"collaborators":44,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":44,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":44,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":44,"overallStatus":144,"whyStopped":44,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Janssen Pharmaceutical K.K.","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 (Chronic Hepatitis C Without Cirrhosis)","EXPERIMENTAL","Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.",[13,14,15],"Drug: AL-335","Drug: Odalasvir (ODV)","Drug: Simeprevir (SMV)",{"label":17,"type":10,"description":18,"interventionNames":19},"Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)","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).",[13,14,15],[21,28,34],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","AL-335","Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.",[9,17],[27],"JNJ-64146212",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Odalasvir (ODV)","Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.",[9,17],[33],"JNJ-64289901",{"type":22,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Simeprevir (SMV)","Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.",[9,17],[39],"TMC435",[41],{"name":42,"affiliation":5,"role":43},"Janssen Pharmaceutical K.K., Japan Clinical Trial","STUDY_DIRECTOR",null,[46,50,58,65,72,74,76,83,85,92,99,106,113,115],{"facility":44,"status":44,"city":47,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":44,"geoPoint":44,"contacts":44},"Amagasaki-shi","Japan","JP",{"facility":44,"status":44,"city":51,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":52,"geoPoint":57,"contacts":44},"Bunkyō City",{"type":53,"coordinates":54},"Point",[55,56],139.4217,35.5331,{"lat":56,"lon":55},{"facility":44,"status":44,"city":59,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":60,"geoPoint":64,"contacts":44},"Hiroshima",{"type":53,"coordinates":61},[62,63],132.45,34.4,{"lat":63,"lon":62},{"facility":44,"status":44,"city":66,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":67,"geoPoint":71,"contacts":44},"Kagoshima",{"type":53,"coordinates":68},[69,70],130.55,31.56667,{"lat":70,"lon":69},{"facility":44,"status":44,"city":73,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":44,"geoPoint":44,"contacts":44},"Kurume-shi",{"facility":44,"status":44,"city":75,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":44,"geoPoint":44,"contacts":44},"Musashino-shi",{"facility":44,"status":44,"city":77,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":78,"geoPoint":82,"contacts":44},"Nagoya",{"type":53,"coordinates":79},[80,81],136.90641,35.18147,{"lat":81,"lon":80},{"facility":44,"status":44,"city":84,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":44,"geoPoint":44,"contacts":44},"Omura-shi",{"facility":44,"status":44,"city":86,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":87,"geoPoint":91,"contacts":44},"Osaka",{"type":53,"coordinates":88},[89,90],135.50107,34.69379,{"lat":90,"lon":89},{"facility":44,"status":44,"city":93,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":94,"geoPoint":98,"contacts":44},"Saitama",{"type":53,"coordinates":95},[96,97],139.65657,35.90807,{"lat":97,"lon":96},{"facility":44,"status":44,"city":100,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":101,"geoPoint":105,"contacts":44},"Sakaishi",{"type":53,"coordinates":102},[103,104],132.71218,33.41239,{"lat":104,"lon":103},{"facility":44,"status":44,"city":107,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":108,"geoPoint":112,"contacts":44},"Sapporo",{"type":53,"coordinates":109},[110,111],141.35,43.06667,{"lat":111,"lon":110},{"facility":44,"status":44,"city":114,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":44,"geoPoint":44,"contacts":44},"Suita-shi",{"facility":44,"status":44,"city":116,"state":44,"zip":44,"country":48,"countryCode":49,"cosmosGeoPoint":117,"geoPoint":121,"contacts":44},"Yokohama",{"type":53,"coordinates":118},[119,120],139.65,35.43333,{"lat":120,"lon":119},{"type":123,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100285254","phase-2-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-100285254",true,"NCT02993250","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","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","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\u002FmL), 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",false,"ALL","20 Years","75 Years",{"count":136,"type":137},33,"ACTUAL","INTERVENTIONAL",[140],"PHASE2","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.",[143],"Hepatitis C, Chronic","COMPLETED","2019-09-10",{"date":147,"type":137},"2019-09-11",{"date":149,"type":137},"2016-12-21",{"date":151,"type":137},"2018-05-07",{"name":5,"class":6},14]