[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100395613":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":27,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":27,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":27,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":27,"overallStatus":81,"whyStopped":27,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"plasma Exchange+Tenofovir+FMT","EXPERIMENTAL","Subjects will receive Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir \\[antiviral\\] 300mg PO once a day .",[13,14,15],"Biological: Plasma Exchange","Drug: Tenofovir","Other: Fecal Mircobiota Transplantation",{"label":17,"type":18,"description":19,"interventionNames":20},"Tenofovir","ACTIVE_COMPARATOR","TabletTenofovir \\[antiviral\\] 300mg per oral once a day",[14],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","Plasma Exchange","Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir \\[antiviral\\] 300mg PO once a day .",[9],null,{"type":29,"name":17,"description":30,"armGroupLabels":31,"otherNames":27},"DRUG","Tenofovir \\[antiviral\\] 300mg PO once a day .",[17,9],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Fecal Mircobiota Transplantation","FMT for 7 days",[9],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Dr G. Srinivasa Reddy, MD","CONTACT","01146300000","srinivasareddygolamari@gmail.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Institute of Liver & Biliary Sciences","RECRUITING","New Delhi","National Capital Territory of Delhi","110070","India","IN",{"type":52,"coordinates":53},"Point",[54,55],77.2148,28.62137,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":40,"phoneExt":27,"email":41},"Dr G Srinivasa Reddy, MD",{"type":61,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100395613","efficacy-of-addition-of-fecal-microbiota-transplant-fmt-and-plasma-exchange-to-tenofovir-in-comparison-to-monotherapy-with-tenofovir-in-aclf-hbv-100395613",false,"NCT04431375","Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV","Inclusion Criteria:\n\n* Age - 18-75 years\n* Patients with ACLF - HBV reactivation according to APASL guidelines.\n* MELD \\\u003C 30 WITH AKI,HE\n* MELD \\\u003C 30 WITH OUT EXTRAHEPATIC FAILURE\n\nExclusion Criteria:\n\n* MELD \\> 30\n* Co existing hepatitis A,E,D\n* HCC\n* Sepsis\n* Alcohol intake, substance abuse, HIV, IBD, chronic constipation or diarrhoea\n* Allergy to plasma, protamine or heparin,\n* Active hemorrhage or disseminated intravascular coagulation (DIC)\n* Unstable hemodynamics (e.g., blood pressure \\\u003C90\u002F60 mmHg, heart rate \\>100 bpm),\n* Cerebral or myocardiac infarction\n* Pregnancy","ALL","18 Years","75 Years",{"count":72,"type":73},70,"ESTIMATED","INTERVENTIONAL",[76],"NA","A randomized controlled trial to study the efficacy of addition of FMT \\& plasma exchange to tenofovir compared to monotherapy with tenofovir in patients with HBV reactivation who develops Acute on chronic liver failure.\n\nIn this study the patients who meet the inclusion criteria will be randomized to either receive Tenofovir or with FMT + plasma exchange along with Tenofovir . Blood samples \\& stool samples will be taken \\& analysis will be done accordingly .The patients are followed for 90 days MELD,APACHE \\& SOFA scores are calculated.Then statistical analysis will be done to find whether the addition of plasma exchange \\& FMT adds benefit compared to tenofovir treatment alone .",[79,80],"Acute-On-Chronic Liver Failure","Hepatitis B","UNKNOWN","2022-01-27",{"date":84,"type":85},"2022-01-31","ACTUAL",{"date":87,"type":85},"2020-06-22",{"date":89,"type":73},"2022-06-10",{"name":5,"class":6},1]