[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569220":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":31,"locations":18,"responsibleParty":37,"collaborators":18,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":18,"eligibilityCriteria":46,"healthyVolunteers":43,"sex":47,"minAge":48,"maxAge":18,"enrollmentInfo":49,"targetDuration":18,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":18,"overallStatus":59,"whyStopped":18,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":18},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"the group will receive obeticholic acid","EXPERIMENTAL","The first group that will receive obeticholic acid for six months",[13],"Drug: Obeticholic Acid 5 mg",{"label":15,"type":16,"description":17,"interventionNames":18},"the group will not receive obeticholic acid","NO_INTERVENTION","Control group",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Obeticholic Acid 5 mg","\\- Patients will be randomly divided into two groups , the first will receive obeticholic acid at a dose of 5 mg once daily and antiviral drug ,and the other will receive the antiviral drug only for six months",[9],[26,29],{"name":27,"affiliation":5,"role":28},"Mahmoud Ali Mahmoud, Professor","STUDY_CHAIR",{"name":30,"affiliation":5,"role":28},"Baha Osman Taha, Lecturer",[32],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"misheal melad fekry, Assistant Lecturer","CONTACT","0201283888183","mesho0js@gmail.com",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Michael Melad Fekry Endrawes","Assistant lecturer of internal medicine","100569220","phase-3-obeticholic-acid-among-chronic-hbv-patients-with-hepatic-steatosis--clinical-and-portal-doppler-outcomes-100569220",false,"NCT06691412","Obeticholic Acid Among Chronic HBV Patients with Hepatic Steatosis : Clinical and Portal Doppler Outcomes","Inclusion Criteria:\n\n* Patients 18 years of age or older who had diagnosed as chronic HBV on treatment with with Controlled Attenuation Parameter (CAP) value more than 238 dB\u002Fm .\n\nExclusion Criteria:\n\n* patients under the age of 18.\n* patients with other viral hepatitis infection .\n* Hepatocellular carcinoma .\n* portal vein thrombosis.\n* Subjects with risk of 2nd hepatic steatosis liver disease (excessive alcohol consumption and medications).\n* history of liver disease such as (α-1 antitrypsin deficiency, autoimmune hepatitis, drug-induced liver injury, 1ry biliary cirrhosis, 1ry sclerosing cholangitis).\n* Body Mass Index (BMI) \\> 35 (to avoid the possibility of Fibroscan failure).\n* Patient with end organ disease.","ALL","18 Years",{"count":50,"type":51},100,"ESTIMATED","INTERVENTIONAL",[54],"PHASE3","In this study, the investigators aimed to evaluate the hepatoprotective effect of OCA against HBV-induced liver injury by comparing patients demographic , laboratory date ( liver function , viremia ) , degree of hepatic steatosis and fibrosis and portal doppler at the beginning and after six months .",[57,58],"Hepatitis B Virus","Steatosis","NOT_YET_RECRUITING","2024-11-14",{"date":62,"type":63},"2024-11-15","ACTUAL",{"date":62,"type":51},{"date":66,"type":51},"2026-03-01",{"name":5,"class":6}]