[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598290":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":42,"centralContacts":47,"locations":53,"responsibleParty":72,"collaborators":11,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":11,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":11,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":56,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Ausper Biopharma Co., Ltd.","INDUSTRY",[8,15,18,22,25],{"label":9,"type":10,"description":11,"interventionNames":12},"AHB-137 (16 weeks) and Peg-IFN","EXPERIMENTAL",null,[13,14],"Drug: AHB-137","Drug: Peg-IFN",{"label":16,"type":10,"description":11,"interventionNames":17},"AHB-137 (24 weeks) and Peg-IFN",[13,14],{"label":19,"type":10,"description":11,"interventionNames":20},"AHB-137 and Hepatitis B vaccine",[13,21],"Drug: Hepatitis B Vaccine",{"label":23,"type":10,"description":11,"interventionNames":24},"AHB-137",[13],{"label":26,"type":10,"description":27,"interventionNames":28},"AHB-137 (24 weeks) and Peg-IFN(24 weeks)","R3 group",[13,14],[30,34,38],{"type":31,"name":23,"description":32,"armGroupLabels":33,"otherNames":11},"DRUG","AHB-137 will be injected.",[23,9,16,26,19],{"type":31,"name":35,"description":36,"armGroupLabels":37,"otherNames":11},"Peg-IFN","Peg-IFN will be administered .",[9,16,26],{"type":31,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"Hepatitis B Vaccine","Hepatitis B vaccine will be administered.",[19],[43],{"name":44,"affiliation":45,"role":46},"Jia","Beijing Friendship Hospital","PRINCIPAL_INVESTIGATOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":11,"email":52},"Lu","CONTACT","0571-86959519","clinicaltrial@ausperbio.com",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":11,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Beijing Friendship Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":62,"coordinates":63},"Point",[64,65],116.39723,39.9075,{"lat":65,"lon":64},[68],{"name":69,"role":50,"phone":70,"phoneExt":11,"email":71},"Zuo","010-63139003","yyyyecp1@163.com",{"type":73,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100598290","phase-2-a-multicenter-study-of-ahb-137-injection-combined-with-other-hepatitis-b-drugs-100598290",false,"NCT07069569","A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs","A Randomized, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Combination With Hepatitis B Vaccine or Pegylated Interferon α-2b (Peg-IFN) in Participants With HBeAg-Negative Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogue (NAs)","Inclusion Criteria:\n\n* Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;\n* Aged between 18 and 65 years at the time of signing the ICF;\n* Body mass index (BMI) within the range of 18-30 kg\u002F m2;\n* HBeAg negative at screening;\n* HBsAg or HBV DNA positive for at least 6 months;\n* Continue antiviral therapy with a single nucleoside (t) ide analogue for more than 6 months prior to screening;\n* Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);\n* Effective contraception as required.\n\nExclusion Criteria:\n\n* Participants who are not eligible for treatment with Peg-IFN\u002Frecombinant hepatitis B vaccine;\n* Clinically significant abnormalities other than a history of chronic HBV infection;\n* Concomitant clinically significant other liver diseases;\n* Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to screening;\n* HCV RNA positive, Human immunodeficiency virus (HIV) positive, syphilis positive;\n* Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) \\> 9.0 kPa;\n* Previous\u002Fcurrent manifestations of hepatic decompensation;\n* Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein concentration (AFP) ≥ 20 ng\u002FmL at screening;\n* Obviously abnormal laboratory test results;\n* History of vasculitis or presence of signs, symptoms, or laboratory tests of underlying vasculitis, and previous\u002Fcurrent other diseases that may be related to vasculitic conditions;\n* QT interval corrected for heart rate (Fridericia method) abnormal;\n* History of extrahepatic disease possibly related to HBV immune status;\n* Participants with a history of malignancy within the past 5 years or who are being evaluated for a possible malignancy;\n* Serious mental illness or history of serious mental illness prior to screening;\n* Suspected history of allergy to any component of the study drug, or allergic constitution;\n* Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study;\n* Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;\n* Current use or use of any immunosuppressive medication within 3 months prior to screening, with the exception of short courses (≤ 2 weeks) or use of topical\u002Finhaled steroids;Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose;Or a history of vaccination within 6 months prior to screening or a live vaccination plan during the trial;\n* Participants requiring regular long-term administration of anticoagulants or antiplatelet drugs;\n* Thyroid dysfunction;\n* Patients with uncontrolled epilepsy and other progressive neurological disorders;\n* Received any antisense oligonucleotides (ASO) or small molecule interfering ribonucleic acid (siRNA) drug;\n* Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.","ALL","18 Years","65 Years",{"count":85,"type":86},200,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B drugs in participants with HBeAg-negative CHB treated with NAs.",[92],"Chronic Hepatitis B",[94],"Hepatitis B, Chronic","2026-05-18",{"date":97,"type":98},"2026-05-20","ACTUAL",{"date":100,"type":98},"2025-06-08",{"date":102,"type":86},"2028-01-15",{"name":5,"class":6},1]