[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551237":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":35,"studyPopulation":35,"armGroups":42,"interventions":50,"overallOfficials":35,"centralContacts":35,"locations":66,"responsibleParty":90,"collaborators":35,"id":92,"slug":35,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":35,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":35,"studyType":104,"phases":105,"briefSummary":106,"conditions":107,"keywords":35,"overallStatus":69,"whyStopped":35,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Beijing 302 Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":35},[9,13],{"measure":10,"description":11,"timeFrame":12},"The rate of HBsAg loss (\u003C0.05 IU\u002Fml) at 24 weeks and 48 weeks","Evaluate the level of HBsAg (IU\u002Fml) at 24 weeks and 48 weeks.","48 weeks",{"measure":14,"description":15,"timeFrame":12},"Incidence of treatment-emergent adverse events\u002Fserious adverse events","Evaluate the treatment-emergent adverse events\u002Fserious adverse events",[17,20,23,26,29,32],{"measure":18,"description":19,"timeFrame":12},"The rate of HBsAg decline > 1log(IU\u002Fml) at 24 weeks and 48 weeks","Evaluate the level of serum HBsAg (IU\u002Fml) at 24 weeks and 48 weeks.",{"measure":21,"description":22,"timeFrame":12},"The rate of HBsAb positive (>10 IU\u002Fml) at 24 weeks and 48 weeks.","The rate of HBsAb positive (\\>10 IU\u002Fml) at 24 weeks and 48 weeks.",{"measure":24,"description":25,"timeFrame":12},"The concentration of HBcrAg (logU\u002FmL) at baseline, 12 weeks, 24 weeks and 48 weeks","Evaluate the level of serum HBcrAg (logU\u002FmL) at baseline, 12 weeks, 24 weeks and 48 weeks.",{"measure":27,"description":28,"timeFrame":12},"The concentration of pgRNA (>10 IU\u002Fml) at baseline, 12 weeks, 24 weeks and 48 weeks","Evaluate the level of serum pgRNA (\\>10 IU\u002Fml) at baseline, 12 weeks, 24 weeks and 48 weeks",{"measure":30,"description":31,"timeFrame":12},"The concentration of anti-HBc (IU\u002Fml) at baseline, 12 weeks, 24 weeks and 48 weeks","Evaluate the level of serum anti-HBc (IU\u002Fml) at baseline, 12 weeks, 24 weeks and 48 weeks",{"measure":33,"description":34,"timeFrame":12},"Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks","Evaluate the frequency and function of T cell, B cell, NK cell (tested by flowcytometry\u002Ffluorospot\u002Felispot)",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"NA","SINGLE_GROUP","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":35},"NONE",[43],{"label":44,"type":45,"description":35,"interventionNames":46},"PD-1 antibody therapy","EXPERIMENTAL",[47,48,49],"Drug: Sintilimab","Drug: NAs","Drug: Peg-IFNα-2b",[51,56,62],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":35},"DRUG","Sintilimab","100mg\u002F10ml\u002F1bottle",[44],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"NAs","tablets",[44],[61],"ETV\u002FTDF\u002FTAF",{"type":52,"name":63,"description":64,"armGroupLabels":65,"otherNames":35},"Peg-IFNα-2b","180ug\u002F0.5ml\u002F1bottle",[44],[67],{"facility":68,"status":69,"city":70,"state":71,"zip":35,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"the Fifth Medical Center, Chinese PLA General Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":75,"coordinates":76},"Point",[77,78],116.39723,39.9075,{"lat":78,"lon":77},[81,86],{"name":82,"role":83,"phone":84,"phoneExt":35,"email":85},"Junliang Fu","CONTACT","86-10-66933214","fjunliang@163.com",{"name":87,"role":83,"phone":88,"phoneExt":35,"email":89},"Fu-Sheng Wang","+861066933328","fswang302@163.com",{"type":91,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","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":102,"type":103},50,"ESTIMATED","INTERVENTIONAL",[37],"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.",[108],"Chronic Hepatitis B","2024-06-17",{"date":111,"type":112},"2024-06-20","ACTUAL",{"date":114,"type":103},"2024-06-15",{"date":116,"type":103},"2025-12-15",{"name":5,"class":6},1]