[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatitis-b-chronic-chb\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatitis-b-chronic-chb":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,54],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100053235","phase-2-study-of-ahb-171-in-chronic-hepatitis-b-participants-100053235",false,"NCT07630727","Study of AHB-171 in Chronic Hepatitis B Participants","An Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of AHB-171 Injection in Participants With Chronic Hepatitis B","Inclusion Criteria:\n\n* Able to fully understand and sign the informed consent form (ICF).\n* Male or female participants, aged 18-65 years (inclusive).\n* Body mass index (BMI) meeting the predefined eligibility range.\n* Chronic hepatitis B (CHB) participants with HBsAg or HBV DNA positivity for ≥6 months at screening.\n* At screening, participants meeting predefined ranges of HBsAg, HBV DNA, and ALT according to prior nucleos(t)ide analogue (NA) treatment history (stable prior treatment or treatment-naive), and meeting corresponding prior antiviral treatment duration requirements.\n* Adopt effective contraceptive measures as required\n\nExclusion Criteria:\n\n* History of any severe systemic disease or malignancy other than chronic HBV infection which, in the opinion of the investigator, makes the subject unsuitable for study participation.\n* Prior history of solid organ or hematopoietic stem cell transplantation.\n* History of any other liver disease that the investigator considers unsuitable for trial.History of autoimmune disease or diseases with potential immune activation risk.\n* History or presence of hepatic decompensation at screening.\n* History of primary liver cancer, or diagnosis\u002Fsuspected liver cancer at screening.\n* Imaging or histological evidence of significant liver fibrosis or cirrhosis within 12 months prior to screening, or a liver stiffness measurement indicative of significant fibrosis or cirrhosis at screening. Major trauma or major surgery within 12 weeks prior to screening\n* History of severe allergies (e.g., to ≥2 allergens) or severe allergy to any component of the study drug, or in the opinion of the investigator, makes the subject unsuitable for participation.\n* Severe infection requiring intravenous anti-infective therapy within 2 weeks prior to screening (excluding chronic HBV infection).\n* History of drug abuse, or alcoholism.\n* Blood donation or blood loss exceeding the specified volume within 12 weeks prior to screening, or planned blood donation during the trial period.\n* Use of immunosuppressants, immunomodulators, cytotoxic drugs, or biologics within 6 months prior to screening.\n* Use of any oligonucleotide drugs or interferon therapy within 12 months prior to screening.\n* Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period.\n* Presence of tattoos, active skin diseases, or other conditions that may interfere with subcutaneous drug administration or observation of injection site reactions.\n* Clinically significant abnormal electrocardiogram (ECG) at screening.\n* Tested positive for HIV，HCV or active syphilis infection.\n* Uncontrolled hypertension at screening.\n* Clinically significant abnormal laboratory test as specified in protocol at screening.\n* Currently participating in another clinical trials, or within the washout period.\n* Any other condition or factor which, in the opinion of the investigator, makes the subject unsuitable for trial participation.","ALL","18 Years","65 Years",{"count":20,"type":21},138,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The study adopts an open-label, multiple-dose design and aims to evaluate the efficacy and safety of AHB-171 Injection after multiple doses in treatment-naïve (HBeAg-negative\u002Fpositive) and nucleos(t)ide analogue (NA)-treated (HBeAg-negative) participants with chronic hepatitis B (CHB)",[27],"Hepatitis B, Chronic (CHB)","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2026-06-24",{"date":36,"type":21},"2029-05-31",{"name":38,"class":39},"Ausper Biopharma Co., Ltd.","INDUSTRY",1,{"id":42,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":43,"targetDuration":4,"studyType":22,"phases":44,"briefSummary":25,"conditions":45,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":53,"locationsCount":40},"100638668",{"count":20,"type":21},[24],[27],"NOT_YET_RECRUITING","2026-06-02",{"date":49,"type":32},"2026-06-05",{"date":51,"type":21},"2026-07-15",{"date":36,"type":21},{"name":38,"class":39},{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100599027","real-world-study-evaluating-the-long-term-outcomes-of-pegylated-interferon--2b-treatment-in-the-families-with-clusters-of-hbv-infection-and-unfavorable-prognosis---a-prospective-controlled-multicenter-cohort-study-100599027","NCT07079150","Real-world Study Evaluating the Long-term Outcomes of Pegylated Interferon α-2b Treatment in the Families With Clusters of HBV Infection and Unfavorable Prognosis - A Prospective, Controlled, Multicenter, Cohort Study","Inclusion Criteria:\n\n* Meet the criteria for a family cluster of unfavorable prognoses associated with HBV infection: that is, patients with HBV infection in two consecutive generations of blood relatives, and at least one patient with cirrhosis or HCC in two or more generations of blood relatives;\n* Chronic HBV-infected individuals from families with unfavorable prognoses clustering (meeting either (1)+(2) or (1)+(3) criteria): (1) Positive for HBsAg for more than 6 months; (2) Treated with nucleos(t)ide analogs (NAs); (3) Compensated cirrhosis due to hepatitis B (for details, see the \"Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)\");\n* A negative pregnancy test within 24 hours before the first administration of medication in the treatment group (for women of childbearing age);\n* No contraindications for interferon treatment.\n\nExclusion Criteria:\n\n* Patients diagnosed with liver cancer or other systemic tumors before treatment;\n* Patients with contraindications to Peg IFN α-2b use (for details, see the \"Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)\");\n* Peripheral blood counts: WBC \\\u003C 3.0 × 10\\^9\u002FL, PLT \\\u003C 70 × 10\\^9\u002FL;\n* Liver function: ALT \\> 5 × upper limit of normal (ULN), TBIL \\> 2 × ULN; Individuals planning to receive organ transplantation or who have already undergone organ transplantation;\n* Those allergic to interferon or with any contraindication listed in the product information;\n* Any other conditions deemed unsuitable for enrollment by the investigator.","70 Years",{"count":62,"type":21},1500,"OBSERVATIONAL","Chronic hepatitis B can develop into cirrhosis and liver cancer, which seriously endangers the life and health of people. In China, HBV is mainly transmitted from mother to child, showing the phenomenon of family clusters. Similarly, cirrhosis and hepatocellular carcinoma occur in familial clusters. Familial clusters of HBV infection with unfavorable prognoses refers to HBV-infected patients from two consecutive generations of blood relatives, with at least one family member diagnosed with hepatitis B-related cirrhosis or hepatocellular carcinoma (HCC). Previous family investigations have shown that the risk and harm of HBV-related cirrhosis and hepatocellular carcinoma are significantly higher in families with familial clusters of HBV infection with unfavorable prognoses than in the general population.\n\nCurrently, antiviral drugs used for CHB mainly include nucleoside analogues (NAs) and interferon-alpha (mainly pegylated interferon-alpha, Peg IFN). NAs mainly inhibits viral replication by blocking the reverse transcription process, but it cannot effectively inhibit the expression of viral proteins such as HBsAg, and rarely achieves clinical cure. Multiple clinical studies have shown that the use of NAs reduces the incidence of cirrhosis decompensation, HCC, and death in patients with CHB compared to untreated or placebo-treated patients. Despite long-term treatment with first-line NAs drugs, CHB patients continue to be at risk of developing hepatocellular carcinoma. Peg IFN α-2b injection is the first-line drug of choice for antiviral treatment of chronic hepatitis B, and its main mechanism of action includes anti-HBV, anti-fibrosis, anti-tumor and regulation of immune response. In 2024, a randomized controlled multicenter study showed that Peg IFN α-2b combined with NAs therapy could effectively prevent hepatocellular carcinoma in CHB patients. There is sufficient evidence in clinical practice that long-term antiviral therapy, whether NAs or Peg IFN α-2b, reduces the risk of cirrhosis, hepatocellular carcinoma, and death in patients with CHB. In conclusion, early antiviral therapy can reduce the risk of developing hepatitis B cirrhosis and hepatocellular carcinoma in CHB patients with familial clusters of HBV infection with unfavorable prognoses.\n\nThe goal of this observational study is to explore the evaluation of pegylated interferon α-2b combined with first-line NAs on the long-term outcome of CHB antiviral therapy with cirrhosis and HCC progression as the main observation targets, compared with only use of NAs in the context of familial clusters of HBV infection with unfavorable prognoses. It is intended to provide high-quality evidence-based medical evidence for the treatment and follow-up of CHB, explore optimal clinical decision-making, and provide global clinical data for the improvement and evaluation of this difficult-to-treat population. The main question it aims to answer is: Can Peg IFN-α-2B combined with NAs therapy improve the long-term outcomes of this particular population of familial clusters of HBV infection with unfavorable prognoses compared to first-line NAs monotherapy? Patients with familial clusters of HBV infection with unfavorable prognoses using Peg IFN-α-2B combined with NAs therapy and NAs monotherapy will be collected laboratory and medical examination data at specified follow-up points, and recorded adverse events and drug combinations in detail for 7 years.",[27,66,67],"Hepatitis B","Hepatitis B Virus (HBV)",[69,70,71,72,73,74],"hepatitis B","family cluster","interferon","antiviral therapy","cirrhosis","hepatocellular carcinoma","2025-07-14",{"date":77,"type":32},"2025-07-22",{"date":79,"type":32},"2025-01-01",{"date":81,"type":21},"2032-01",{"name":83,"class":84},"First Affiliated Hospital Xi'an Jiaotong University","OTHER",2]