[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587045":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":43,"locations":48,"responsibleParty":67,"collaborators":24,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":24,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":24,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":24,"overallStatus":89,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Huashan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"A：Immediate PEG-IFNα Induction","EXPERIMENTAL","Receive PEG-IFNα for 24 weeks, followed by 24-week treatment-free follow-up",[13],"Drug: Pegylated Interferon-alpha (IFN)",{"label":15,"type":10,"description":16,"interventionNames":17},"B: Deferred PEG-IFNα Initiation","Undergo 24-week observation, then receive PEG-IFNα for 24 weeks",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Pegylated Interferon-alpha (IFN)","pegylated interferon-alpha 180 μg once weekly for 24 weeks",[9,15],null,[26,29,31,33,36,38,41],{"name":27,"affiliation":5,"role":28},"Wenghong Zhang, MD","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":28},"Jiming Zhang, MD",{"name":32,"affiliation":5,"role":28},"Yuxian Huang, MD",{"name":34,"affiliation":5,"role":35},"Feng Sun, MD","STUDY_CHAIR",{"name":37,"affiliation":5,"role":28},"Chao Qiu",{"name":39,"affiliation":5,"role":40},"Chen Chen, MD","STUDY_DIRECTOR",{"name":42,"affiliation":5,"role":40},"Qiran Zhang, MD",[44],{"name":27,"role":45,"phone":46,"phoneExt":24,"email":47},"CONTACT","13801844344","zhangwenhong@fudan.edu.cn",[49],{"facility":50,"status":24,"city":51,"state":52,"zip":24,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Huashan Hospita","Shanghai","China","CN",{"type":55,"coordinates":56},"Point",[57,58],121.45806,31.22222,{"lat":58,"lon":57},[61,63],{"name":62,"role":45,"phone":46,"phoneExt":24,"email":47},"Wenhong Zhang, Professor",{"name":64,"role":45,"phone":24,"phoneExt":65,"email":66},"Feng Sun, Doctor","15921403893","aaronsf1125@126.com",{"type":28,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Wen-hong Zhang","Director of Division of Infectious Diseases","100587045","sequential-peg-ifn-for-hbv-after-ending-rna-targeted-regimens-100587045",false,"NCT06923280","Sequential PEG-IFN for HBV After Ending RNA-targeted Regimens","Efficacy and Safety of Pegylated Interferon Therapy in Chronic Hepatitis B Patients After Discontinuation of Antisense Oligonucleotide or Small Interfering RNA: A Prospective, Adaptive, Open-label, Randomized Controlled Study","Inclusion Criteria:\n\n* Age ≥18 years.\n* Chronic HBV infection (documented HBsAg positivity for \\>6 months).\n* Prior participation in ASO or siRNA clinical trials:\n* Received ≥1 dose of ASO\u002FsiRNA (or matched placebo, if applicable).\n* Achieved ≥1 log10 IU\u002FmL HBsAg decline from baseline during prior therapy.\n* Discontinued ASO\u002FsiRNA therapy before screening.\n* Screening HBsAg: 0.05-500 IU\u002FmL.\n* No prior interferon (IFN) therapy within 6 months before enrollment.\n* Willingness to comply with study-related treatments, tests, and procedures.\n* Commitment to contraception during the study.\n* Voluntary participation with signed informed consent.\n\nExclusion Criteria:\n\n* Decompensated cirrhosis or hepatic malignancy (evidenced by imaging or histology within 6 months before\u002Fduring screening).\n* Elevated AFP: Screening AFP \\>100 ng\u002FmL; AFP 20-100 ng\u002FmL with imaging-confirmed hepatocellular carcinoma (ultrasound\u002FCT\u002FMRI).\n* Coinfection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV).\n* Recent immunomodulatory therapy: Systemic corticosteroids, thymosin, or other potent immunomodulators for \\>2 weeks within 6 months before enrollment.\n* Pregnancy, lactation, or plans for pregnancy during the study.\n* Autoimmune hepatitis.\n* Active autoimmune diseases (e.g., psoriasis, systemic lupus erythematosus).\n* Uncontrolled cardiovascular disease (e.g., unstable angina, myocardial infarction within 6 months).\n* Poorly controlled endocrine disorders (e.g., diabetes mellitus, thyroid dysfunction).\n* Severe psychiatric disorders: History of depression, anxiety, bipolar disorder, schizophrenia, or family history of psychiatric conditions (especially depression).\n* Substance abuse: Alcohol (\\>40 g\u002Fday for males; \\>20 g\u002Fday for females) or Illicit drug use.\n* Severe retinopathy or ophthalmologic disorders.\n* Renal diseases: Chronic nephritis, renal insufficiency, nephrotic syndrome.\n* Major organ dysfunction (e.g., heart, lung, pancreas).\n* Organ transplant recipients or candidates.\n* Hypersensitivity to interferon or excipients.\n* Concurrent participation in other HBV-related interventional trials.\n* Other conditions deemed unsuitable by investigators (e.g., non-compliance risk).","ALL","18 Years","80 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this clinical trial is to compare sequential PEG-IFNα therapy strategies in chronic hepatitis B (CHB) patients previously treated with ASO\u002FsiRNA. The main questions it aims to answer are:\n\n1. Does sequential PEG-IFNα therapy (vs. deferred\u002Fno treatment) improve HBsAg clearance rates?\n2. What are the HBsAg clearance and relapse rates after 24 weeks of PEG-IFNα therapy?\n3. Is intermittent PEG-IFNα therapy as effective and safe as continuous therapy?\n\nResearchers will compare:\n\n• Group A (immediate 24-week PEG-IFNα + 24-week follow-up) vs. Group B (24-week observation + 24-week PEG-IFNα) in Phase 1 to see if sequential PEG-IFNα therapy will improve HBsAg loss rate .\n\nResearchers will describe:\n\n* The response rate of IFN treatment in non-responders (HBsAg-positive) in Phase 2.\n* The relaspe rate of responders (HBsAg-negative).\n\nParticipants will:\n\nPhase 1 (0-48 weeks):\n\n* Group A: Receive PEG-IFNα for 24 weeks, followed by 24-week treatment-free follow-up.\n* Group B: Undergo 24-week observation, then receive PEG-IFNα for 24 weeks.\n\nPhase 2 (48-96 weeks):\n\n* HBsAg-positive at week 48 patients either from group A or group B : Receive 24-week PEG-IFNα therapy, followed by 24-week follow-up.\n* HBsAg-negative at week 48 patients either from group A or group B: Enter 24-week follow-up without treatment.\n\nAll participants will undergo:\n\n• HBsAg quantification, HBV DNA, liver function, and safety monitoring (every 12 weeks).",[88],"Hepatitis B, Chronic","NOT_YET_RECRUITING","2025-04-09",{"date":92,"type":93},"2025-04-11","ACTUAL",{"date":95,"type":82},"2025-05-01",{"date":97,"type":82},"2028-05-31",{"name":5,"class":6},1]