[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-hep-b\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-hep-b":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100567661","phase-1-phase-1b-open-label-study-of-tune-401-to-assess-safety-pk-and-pd-in-adults-with-chronic-hepatitis-b-100567661",false,"NCT06671093","Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B","Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection","Inclusion Criteria:\n\n* M\u002FF, BMI ≥ 18.5 kg\u002Fm² at screening, age 18-75, inclusive\n* Diagnosed with Chronic Hepatitis B\n* On nucleos(t)ide analogue\n* HBeAg-negative or positive\n\nExclusion Criteria:\n\n* ALT\u002F AST ≥ 1.5 × upper limit of normal (ULN) and total bilirubin ≥ 1. 5 × ULN\n* Participants with any evidence or history of liver disease of non-HBV etiology\n* Other protocol defined Inclusion\u002FExclusion criteria may apply","ALL","18 Years","75 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Tune-401 in adult participants with Chronic Hepatitis B.",[27,28,29,30],"Chronic Hep B","Chronic Hepatitis b","Chronic Hepatitis","HBV",[32,33,34],"Tune-401","Tune-401-001","CHB","RECRUITING","2026-01-02",{"date":38,"type":39},"2026-01-06","ACTUAL",{"date":41,"type":39},"2024-11-29",{"date":43,"type":21},"2028-10-30",{"name":45,"class":46},"Tune Therapeutics, Inc.","INDUSTRY",3,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100603494","immune-dynamics-in-the-natural-history-of-chronic-hbv-infection-100603494","NCT07137247","Immune Dynamics in the Natural History of Chronic HBV Infection","Inclusion Criteria:\n\n* Aged 1-80 years, either male or female.\n* Patients diagnosed with chronic hepatitis B virus infection in accordance with the \"Guidelines for the Prevention and Treatment of Chronic Hepatitis B\" (2019 edition).\n* No antiviral treatment (including nucleoside analogs and interferons, etc.) within the past six months.\n\nExclusion Criteria:\n\n• Concurrent Infections and Liver Diseases: Exclusion of patients with concurrent HCV or HIV infection, alcoholic fatty liver disease, non-alcoholic fatty liver disease, autoimmune liver diseases.\n\n• Immune and Coagulation System Disorders: Exclusion of patients with immune system diseases such as hyperthyroidism, coagulation system disorders such as diabetes mellitus or idiopathic thrombocytopenic purpura.\n\n* Severe Underlying Diseases. Exclusion of patients with severe underlying diseases that affect the body's immune status.\n* Other Unsuitable Conditions:\n\nExclusion of patients whom the investigator deems to have other conditions that make them unsuitable for enrollment.","1 Year","80 Years",{"count":57,"type":21},5000,"3 Years","OBSERVATIONAL","The purpose of this observational study is to follow up on chronic HBV-infected patients over a long period of time to understand the changes in the immune status as age increases and the natural history of chronic HBV infection progresses. The main questions it aims to answer are:\n\n* Does the natural history of chronic HBV infection progress with changes in HBV-specific immunity?\n* What is the role of age in the natural history of chronic HBV infection?\n\nPatients with chronic HBV infection who are untreated and aged 1-80 years will be followed up every six months. During each follow-up, HBV-related serological and virological indicators will be tested. Peripheral blood samples will also be collected to test HBV-specific immunity and the immune environment.",[62,63,27],"HBV (Hepatitis B Virus)","HBV Infection",[30,27,65],"HBV infection","2025-09-28",{"date":68,"type":39},"2025-09-30",{"date":70,"type":39},"2024-02-01",{"date":72,"type":21},"2041-12-01",{"name":74,"class":75},"Nanfang Hospital, Southern Medical University","OTHER",1]