[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607033":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":60,"collaborators":11,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":11,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":83,"whyStopped":11,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Xiamen Humanity Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL",null,[13],"Drug: Peginterferon alfa-2b combined with NAs",{"label":15,"type":10,"description":11,"interventionNames":16},"Group 2",[17],"Drug: NAs",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Peginterferon alfa-2b combined with NAs","Subcutaneous injection therapy,Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status.",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"NAs","Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status.",[15],[29],{"name":30,"affiliation":5,"role":31},"Wenqi Huang","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":11,"email":36},"CONTACT","18965179823","huangwenqi@haxm.com",[38,52],{"facility":39,"status":11,"city":40,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Xiamen Hospital of Traditional Chinese Medicine","Xiamen","China","CN",{"type":44,"coordinates":45},"Point",[46,47],118.08187,24.47979,{"lat":47,"lon":46},[50],{"name":51,"role":34,"phone":11,"phoneExt":11,"email":11},"Hong Cai",{"facility":53,"status":11,"city":40,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"Zhongshan Hospital Affiliated to Xiamen University",{"type":44,"coordinates":55},[46,47],{"lat":47,"lon":46},[58],{"name":59,"role":34,"phone":11,"phoneExt":11,"email":11},"Ligang Chen",{"type":31,"investigatorFullName":30,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Chief physician","100607033","a-study-on-peginterferon-alfa-2b-combined-with-nas-in-compensated-hbv-cirrhosis-100607033",false,"NCT07183293","A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis","A Multicenter, Randomized, Prospective Study on the Efficacy and Safety of Peginterferon Alfa-2b Combined With Nucleos(t)Ide Analogues in Patients With Compensated HBV-Related Liver Cirrhosis","Inclusion Criteria:\n\n1. Clinical diagnosis of compensated HBV-related liver cirrhosis (Child-Pugh class A or B);\n2. The subject is able to understand and comply with the content, requirements, and restrictions of the protocol, is willing and able to complete the study per protocol requirements, fully understands the potential adverse reactions, and voluntarily provides written informed consent prior to study initiation;\n3. Aged 18 to 60 years (inclusive), any gender;\n4. Female subjects of childbearing potential must have a negative pregnancy test at screening;\n5. Subjects (including their partners) must voluntarily use effective non-drug contraception from prior to dosing until six months after discontinuation of the study drug and have no plan to donate sperm or ova; or subjects (including their partners) are of non-childbearing potential (surgically sterilized or postmenopausal).\n\nExclusion Criteria:\n\n1. Decompensated liver cirrhosis, hepatic failure, or hepatocellular carcinoma; presence of other liver diseases such as fatty liver disease, alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, or Wilson's disease;\n2. History of clinically significant diseases of the cardiovascular, hematological and lymphatic, respiratory, urinary, endocrine, immune, psychiatric, or nervous systems (e.g., epilepsy), ophthalmic diseases, or thyroid-related disorders;\n3. Pregnancy, lactation, or intention to become pregnant during the study period;\n4. Known or suspected allergy to the investigational product(s) or any of its excipients;\n5. Participation in any other interventional clinical trial within 3 months prior to screening or planning to participate in another clinical trial during the study;\n6. Any other condition considered by the investigator to be inappropriate for participation in the study.","ALL","18 Years","60 Years",{"count":73,"type":74},30,"ESTIMATED","INTERVENTIONAL",[77],"NA","This study is a multicenter, randomized, prospective trial designed to evaluate the efficacy and safety of pegylated interferon α-2b (Peg-IFN-α2b) combined with nucleos(t)ide analogues (NAs) versus NAs monotherapy in patients with compensated hepatitis B cirrhosis. A total of 30 patients with compensated HBV-related cirrhosis will be enrolled and randomized in a 2:1 ratio to either Experimental Group 1 (n=20) or Experimental Group 2 (n=10). The treatment regimens consist of Peg-IFN-α2b combined with NAs (ETV\u002FTAF\u002FTMF\u002FTDF) or NAs (ETV\u002FTAF\u002FTMF\u002FTDF) monotherapy.",[80],"HBV-related Liver Cirrhosis",[82],"Peginterferon α-2b","NOT_YET_RECRUITING","2025-09-17",{"date":86,"type":87},"2025-09-19","ACTUAL",{"date":89,"type":74},"2025-10",{"date":91,"type":74},"2031-09",{"name":5,"class":6},2]