[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407642":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":42,"centralContacts":46,"locations":56,"responsibleParty":75,"collaborators":51,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":51,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":51,"enrollmentInfo":86,"targetDuration":51,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":58,"whyStopped":51,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Mercy Medical Center","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Cirrhosis, 3-dose regimen","EXPERIMENTAL","Investigators will randomize the patient in the cirrhotic group to receive a 3-dose regimen of Heplisav-B.",[13],"Biological: Heplisav-B Injectable Product, 3-dose regimen",{"label":15,"type":16,"description":17,"interventionNames":18},"Cirrhosis, 2-dose regimen","ACTIVE_COMPARATOR","Investigators will randomize the patient in the cirrhotic group to receive a 2-dose regimen of Heplisav-B.",[19],"Biological: Heplisav-B Injectable Product, 2-dose regimen",{"label":21,"type":10,"description":22,"interventionNames":23},"Non cirrhosis, 3-dose regimen","Investigators will randomize the patient in the noncirrhotic group to receive a 3-dose regimen of Heplisav-B.",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Non cirrhosis, 2-dose regimen","Investigators will randomize the patient in the noncirrhotic group to receive a 2-dose regimen of Heplisav-B.",[19],[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BIOLOGICAL","Heplisav-B Injectable Product, 2-dose regimen","Investigators will randomly assign patients into a 2-dose regimen.",[15,25],[35],"2-dose regimen",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Heplisav-B Injectable Product, 3-dose regimen","Investigators will randomly assign patients into a 3-dose regimen.",[9,21],[41],"3-dose regimen",[43],{"name":44,"affiliation":5,"role":45},"Paul Thuluvath, MD","PRINCIPAL_INVESTIGATOR",[47,53],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"CHAU TO, MD","CONTACT","(714)-400-1331",null,"cto@mdmercy.com",{"name":44,"role":49,"phone":54,"phoneExt":51,"email":55},"(410)-332-9308","pthuluv@mdmercy.com",[57],{"facility":5,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Baltimore","Maryland","21202","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-76.61219,39.29038,{"lat":68,"lon":67},[71,73],{"name":48,"role":49,"phone":72,"phoneExt":51,"email":52},"714-400-1331",{"name":74,"role":49,"phone":54,"phoneExt":51,"email":55},"PAUL THULUVATH, MD",{"type":76,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100407642","phase-4-comparison-between-2-dose-versus-3-dose-regimens-of-heplisav-b-in-cirrhosis-100407642",false,"NCT04588077","Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis","Comparison the Seroconversion Rate Between Two-dose and Three-dose Regimens of Heplisav B Among Patients With Cirrhosis, a Randomized-control Prospective Study.","Inclusion Criteria:\n\n\\- All the cirrhosis patients more than 18 years old presented to the hepatology clinic in Mercy Medical Center between 09\u002F2020 and 07\u002F2021 who do not have immunity against Hepatitis B (defined as anti-HBs titer \\\u003C 10 mIU\u002Fml) will be recruited.\n\nExclusion Criteria:\n\n* Anyone who has had a serious allergic reaction to a prior dose of the hepatitis B vaccine, a component of the hepatitis B vaccine, or yeast should not receive the hepatitis B vaccine.\n* Those who had previous exposure to hepatitis B.\n* Post liver transplant patients.\n* Less than 18 years old.","ALL","18 Years",{"count":87,"type":88},200,"ESTIMATED","INTERVENTIONAL",[91],"PHASE4","Investigators want to compare the seroconversion rates between two-dose and three-dose regimens of the hepatitis B vaccine (Heplisav B) among patients with cirrhosis, a randomized prospective study.",[94,95,96],"Hepatitis B","Cirrhosis, Liver","Chronic Liver Disease",[98,99,100,101,102,103,104,105,106],"hepatitis B vaccine","Heplisav-B","cirrhosis","chronic liver disease","2 dose regimen","3 dose regimen","non responder","poor responder","no response","2024-11-18",{"date":109,"type":110},"2024-11-19","ACTUAL",{"date":112,"type":110},"2020-09-14",{"date":114,"type":88},"2028-12-01",{"name":5,"class":6},1]