[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100101417":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":26,"locations":35,"responsibleParty":47,"collaborators":26,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":26,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CsA-TAC","ACTIVE_COMPARATOR","Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor \\[CNI\\] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)\\[MPA\\], with or without steroids) \u002F no everolimus introduction.",[13],"Drug: CsA-TAC (standard Treatment)",{"label":15,"type":16,"description":17,"interventionNames":18},"everolimus","EXPERIMENTAL","Initiation of everolimus with discontinuation of CNI\u002FMPA, with or without steroids.",[19],"Drug: Everolimus",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","CsA-TAC (standard Treatment)","Continuation of current immunosuppressive regimen (continuation of CNI with or without MPA, with or without steroids) \u002F no everolimus introduction.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Everolimus","Hepatitis C recurrence after orthotopic liver transplantation (OLT)",[15],[32],{"name":33,"affiliation":33,"role":34},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[36],{"facility":37,"status":26,"city":38,"state":26,"zip":26,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":26},"Novartis Investigative site","Buenos Aires","Argentina","AR",{"type":42,"coordinates":43},"Point",[44,45],-58.37723,-34.61315,{"lat":45,"lon":44},{"type":48,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100101417","phase-2-efficacy-of-everolimus-as-inhibitor-of-fibrosis-progression-in-liver-transplant-patients-with-recurrence-of-hepatitis-c-viral-infection-100101417",true,"NCT00582738","Efficacy of Everolimus as Inhibitor of Fibrosis Progression in Liver Transplant Patients With Recurrence of Hepatitis C Viral Infection","A Randomized, Controlled, Open Label, Two Arms, Exploratory Study to Evaluate the Effect of Everolimus on Histologically Assessed Fibrosis Progression (Ishak-Knodell) in Liver Transplant Recipients With Recurrent Hepatitis C Viral Infection as Compared to Standard Treatment.","REVERT","Inclusion Criteria:\n\n* Male or female patients 18 - 65 years of age\n* Recipients of deceased or living donors\n* Patients who had undergone primary liver transplantation at least 6 months before enrolment\n* Recurrent Hepatitis C viral infection and histologically confirmed liver fibrosis (stage I-IV in the Ishak-Knodell scale) obtained at baseline or within the previous 6 months to the date of enrolment\n* Patients receiving tacrolimus or cyclosporine micro-emulsion with or without - Mycophenolic acid (MPA), with or without steroids.\n* Absence of acute rejection episodes within the previous 6 months to the date of enrolment\n* Patient in whom an allograft biopsy will not be contraindicated\n* Patient willing and capable of giving written informed consent for study participation and able to participate in the study for 24 months\n* Patients with Hepatocellular carcinoma (HCC) within the University California, San Francisco (UCSF) Criteria and no recurrence for at least 18 months after OLT.\n\nExclusion Criteria:\n\n* Recipients of multiple organ transplants or patients who have undergone retransplantation\n* Current biliary complications\n* History of drug or alcohol abuse within 1 year before enrolment\n* Patients treated with anti-hepatitis C virus treatment at the time of enrollment or within the previous month to the date of enrolment\n* Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)\n* Patients with Leukocyte count (WBC) \\\u003C 3000\u002Fmm3, platelet count \\\u003C 75000\u002Fmm3 or Hemoglobin (Hb) \\\u003C 8 g\u002Fdl\n* Patients with proteinuria \\>1g\u002F24 hours\n* Patient with a current severe systemic infection\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.",false,"ALL","18 Years","65 Years",{"count":62,"type":63},43,"ACTUAL","INTERVENTIONAL",[66],"PHASE2","This study will assess the efficacy of everolimus as an inhibitor of fibrosis progression in liver transplant patients who have a recurrence of hepatitis C viral infection in the transplant",[69],"Recurrent Hepatitis C",[71,72,73,74,15,29],"Fibrosis progression","recurrent hepatitis C","viral infection","liver transplant recipients","TERMINATED","2012-08-02",{"date":78,"type":79},"2012-09-06","ESTIMATED",{"date":81,"type":26},"2007-12",{"date":83,"type":63},"2010-01",{"name":33,"class":6},1]