[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100204490":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":45,"centralContacts":28,"locations":49,"responsibleParty":99,"collaborators":28,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":28,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":28,"enrollmentInfo":111,"targetDuration":28,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":127,"whyStopped":28,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Janssen R&D Ireland","INDUSTRY",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1","EXPERIMENTAL","Participants with Metavir fibrosis score F1-F2 will receive treatment with combinational regimen of simeprevir, daclatasvir, and ribavirin along with cyclosporine or tacrolimus as stable immunosuppressant therapy.",[13,14,15,16,17],"Drug: Simeprevir","Drug: Daclatasvir","Drug: Ribavirin","Drug: Cyclosporine","Drug: Tacrolimus",{"label":19,"type":10,"description":20,"interventionNames":21},"Part 2","Participants with Metavir fibrosis score F1-F4 will receive treatment with combinational regimen of simeprevir, daclatasvir, and ribavirin along with tacrolimus as stable immunosuppressant therapy.",[13,14,15,17],[23,29,33,37,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Simeprevir","Participants will receive 150 milligram capsule of simeprevir orally (by mouth) once daily with food for 24 weeks. In Part 1, if simeprevir pre-dose plasma concentration is greater than 7,300 nanogram per milliliter (ng\u002FmL), participants will receive simeprevir 150 milligram capsule orally every other day to complete 24 weeks of treatment.",[9,19],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Daclatasvir","Participants will receive 60 milligram tablet of daclatasvir orally once daily for 24 weeks.",[9,19],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Ribavirin","Participants will receive 5 or 6 tablets of 200 milligram of ribavirin orally twice a day with food for 24 weeks.",[9,19],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Cyclosporine","Participants will receive cyclosporine as one of the stable immunosuppressant therapy (no change in dose in the last month) for more than 3 months prior to the screening visit. Cyclosporine will be administered as per the manufacturer's prescribing information for 24 weeks.",[9],{"type":24,"name":42,"description":43,"armGroupLabels":44,"otherNames":28},"Tacrolimus","Participants will receive tacrolimus as one of the stable immunosuppressant therapy (no change in dose in the last month) for more than 3 months prior to the screening visit. Tacrolimus will be administered as per the manufacturer's prescribing information for 24 weeks.",[9,19],[46],{"name":47,"affiliation":5,"role":48},"Janssen R&D Ireland Clinical Trial","STUDY_DIRECTOR",[50,60,67,76,85,92],{"facility":28,"status":28,"city":51,"state":28,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":28},"Essen","Germany","DE",{"type":55,"coordinates":56},"Point",[57,58],7.01228,51.45657,{"lat":58,"lon":57},{"facility":28,"status":28,"city":61,"state":28,"zip":28,"country":52,"countryCode":53,"cosmosGeoPoint":62,"geoPoint":66,"contacts":28},"Hamburg",{"type":55,"coordinates":63},[64,65],9.99302,53.55073,{"lat":65,"lon":64},{"facility":28,"status":28,"city":68,"state":28,"zip":28,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":28},"Warsaw","Poland","PL",{"type":55,"coordinates":72},[73,74],21.01178,52.22977,{"lat":74,"lon":73},{"facility":28,"status":28,"city":77,"state":28,"zip":28,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":28},"Barcelona","Spain","ES",{"type":55,"coordinates":81},[82,83],2.15899,41.38879,{"lat":83,"lon":82},{"facility":28,"status":28,"city":86,"state":28,"zip":28,"country":78,"countryCode":79,"cosmosGeoPoint":87,"geoPoint":91,"contacts":28},"Madrid",{"type":55,"coordinates":88},[89,90],-3.70256,40.4165,{"lat":90,"lon":89},{"facility":28,"status":28,"city":93,"state":28,"zip":28,"country":78,"countryCode":79,"cosmosGeoPoint":94,"geoPoint":98,"contacts":28},"Valencia",{"type":55,"coordinates":95},[96,97],-0.37966,39.47391,{"lat":97,"lon":96},{"type":100,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100204490","phase-2-a-study-of-pharmacokinetics-efficacy-safety-tolerability-of-the-combination-of-simeprevir-tmc435-daclatasvir-bms-790052-and-ribavirin-rbv-in-patients-with-recurrent-chronic-hepatitis-c-genotype-1b-infection-after-orthotopic-liver-transplantation-100204490",true,"NCT01938625","A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation","Phase 2, Open-Label Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Tolerability of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052) and Ribavirin (RBV) in Subjects With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation","Inclusion Criteria:\n\n* Liver transplant between 6 months and 10 years prior to the screening visit\n* Hepatitis C virus (HCV) genotype 1 subtype b infection confirmed at screening\n* Screening HCV ribonucleic acid level greater than 10,000 IU\u002FmL\n* HCV treatment-naïve participants must not have received post orthotopic liver transplant treatment with any approved or investigational drug for the treatment of HCV\n* Receiving stable immunosuppressant therapy (ie, no change in dose in the last month) with cyclosporine (only allowed in Part 1) or tacrolimus for more than 3 months prior to the screening visit\n\nExclusion Criteria:\n\n* Evidence of acute or chronic hepatic decompensation after the liver transplantation (including ascites, bleeding varices or hepatic encephalopathy)\n* Any liver disease of non-HCV etiology, including current evidence of graft rejection except the presence of liver steatosis\n* Any other clinically significant disease that in the opinion of the investigator would be exacerbated by the known effects of ribavirin\n* Coinfection with HCV of another genotype than genotype 1b, HIV type 1 or 2 (positive HIV-1 or HIV-2 antibodies test at screening), and hepatitis B virus (hepatitis B surface antigen positive)\n* Multi-organ transplant that included heart, lung, pancreas, or kidney",false,"ALL","18 Years",{"count":112,"type":113},35,"ACTUAL","INTERVENTIONAL",[116],"PHASE2","The purpose of the study is to evaluate effect of steady-state (when the amount of drug administered (in a given time period is equal to the amount of drug eliminated in that same period) of simeprevir and daclatasvir on the steady-state pharmacokinetics (what a medication does to the body) of cyclosporine (applicable to Part 1 only) and tacrolimus when administered as a combinational regimen in post-orthotopic liver transplantation (OLT) participants with recurrent hepatitis C virus (HCV) genotype 1b infection and effectiveness of a 24-week treatment regimen containing simeprevir, daclatasvir, and ribavirin (RBV) with respect to the proportion of HCV genotype 1b infected post-OLT participants achieving sustained virologic response 12 weeks after end of treatment.",[119],"Hepatitis C, Chronic",[119,121,122,25,30,34,123,124,125,126],"Recurrent Chronic Hepatitis C","Pharmacokinetics","Orthotopic Liver Transplantation","TMC435","BMS-790052","RBV","COMPLETED","2018-11-20",{"date":130,"type":113},"2018-11-21",{"date":132,"type":113},"2013-12-12",{"date":134,"type":113},"2015-07-28",{"name":5,"class":6},6]