[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551237":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":11,"centralContacts":11,"locations":32,"responsibleParty":56,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":11,"overallStatus":35,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Beijing 302 Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PD-1 antibody therapy","EXPERIMENTAL",null,[13,14,15],"Drug: Sintilimab","Drug: NAs","Drug: Peg-IFNα-2b",[17,22,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"DRUG","Sintilimab","100mg\u002F10ml\u002F1bottle",[9],{"type":18,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"NAs","tablets",[9],[27],"ETV\u002FTDF\u002FTAF",{"type":18,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"Peg-IFNα-2b","180ug\u002F0.5ml\u002F1bottle",[9],[33],{"facility":34,"status":35,"city":36,"state":37,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"the Fifth Medical Center, Chinese PLA General Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},[47,52],{"name":48,"role":49,"phone":50,"phoneExt":11,"email":51},"Junliang Fu","CONTACT","86-10-66933214","fjunliang@163.com",{"name":53,"role":49,"phone":54,"phoneExt":11,"email":55},"Fu-Sheng Wang","+861066933328","fswang302@163.com",{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100551237","sequential-combination-therapy-with-pd-1-antibody-and-peg-ifn-in-chb-patients-100551237",false,"NCT06457477","Sequential Combination Therapy With PD-1 Antibody and Peg-IFNα in CHB Patients","The Safety and Efficacy of Sequential Combination Therapy With PD-1 Antibody and Pegylated Interferon-α in NA-supressed Chronic Hepatitis B Patients","Inclusion Criteria:\n\n* 1\\. 18 - 65 years old;\n* 2.Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);\n* 3\\. In virologically suppressed (HBV DNA below the lower detection limit) CHB patients by NAs treatment, HBsAg decreased by less than 0.5log in the last 6 months of Peg-IFNα therapy, and then discontinued Peg-IFNα at least 6 months;\n* 4.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 200IU\u002Fml at Peg-IFNα discontinuation and enrollment.\n\nExclusion Criteria:\n\n* 1\\. Cirrhosis;\n* 2.platelet count \\\u003C 90×109\u002FL, WBC count \\\u003C 3.0×109\u002FL, neutrophil count \\\u003C 1.3×109\u002FL, ALT \\> ULN (40U\u002FL), total bilirubin \\> 2ULN;\n* 3.History of or suspicion of hepatocellular carcinoma\n* 4.Patients received immunosuppressive therapy or other therapy influenced study within 12 months;\n* 5.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;\n* 6.Alcohol or drug abuse\u002Fdependence;\n* 7.Investigator judges that the participants are not suitable for this study.","ALL","18 Years","65 Years",{"count":69,"type":70},50,"ESTIMATED","INTERVENTIONAL",[73],"NA","This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.",[76],"Chronic Hepatitis B","2024-06-17",{"date":79,"type":80},"2024-06-20","ACTUAL",{"date":82,"type":70},"2024-06-15",{"date":84,"type":70},"2025-12-15",{"name":5,"class":6},1]