[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-hepatitis-b\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-hepatitis-b":57},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,64,0,25,[9,39,68,93,120,142,165,184,210,236,258,278,298,315,343,366,392,414,435,462,482,513,531,558,579],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100565141","hepatitis-delta-virus-infection-cross-sectional-study-in-patients-with-chronic-hepatitis-b-virus-infection-100565141",false,"NCT06638320","Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection","Inclusion Criteria:\n\n* Patients ≥ 16 years old undergo testing at the Testing Center of Tam Anh General Hospital or Tam Anh TP. Ho Chi Minh General Hospital, with chronic hepatitis B HBsAg (+) standards for six months or over or HBsAg (+) combined with HBcAb total (+) and HBcAb-immunoglobulin M (-).\n* Patients ≥ 16 years old with chronic hepatitis B come to be examined or are inpatients at the Gastroenterology - Hepatobiliary Center of Bach Mai Hospital, diagnosed with hepatocellular carcinoma, and cirrhosis\n\nExclusion Criteria:\n\n* Patients do not agree to participate in the study or refuse to sign a written informed consent.","ALL","16 Years",{"count":19,"type":20},2452,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to determine the prevalence of hepatitis D virus (HDV) and the distribution of the HDV genotype in patients with chronic hepatitis B infection. It will also identify factors related to hepatitis D virus infection, such as characteristics of the study sample, vaccination history, drug use affecting hepatitis, family factors, environment, and lifestyle.\n\nThis study will be conducted at Tam Anh General Hospital, Bach Mai Hospital and Tam Anh TP. Ho Chi Minh General Hospital.\n\nParticipants will be interviewed directly through a questionnaire to collect some information related to epidemiological risk factors. A blood sample will also be collected.",[24,25],"Hepatitis Delta With Hepatitis B Carrier State","Chronic Hepatitis b","RECRUITING","2026-06-17",{"date":29,"type":30},"2026-06-22","ACTUAL",{"date":32,"type":30},"2024-11-01",{"date":34,"type":20},"2026-12-30",{"name":36,"class":37},"Tam Anh Research Institute","OTHER",3,{"id":40,"slug":41,"hasResults":12,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100555530","phase-1-thervacb---a-heterologous-protein-primemva-boost-therapeutic-hepatitis-b-vaccine-candidate-100555530","NCT06513286","TherVacB - A Heterologous Protein Prime\u002FMVA Boost Therapeutic Hepatitis B Vaccine Candidate","TherVacB - A Multi-center Phase 1b\u002F2a Trial to Assess Safety, Tolerability and Immunogenicity of a Heterologous Protein Prime\u002FMVA Boost Therapeutic Hepatitis B Vaccine Candidate","TherVacB","Inclusion Criteria:\n\n1. Ability to understand the subject information and to personally name, sign and date the informed consent to participate in the clinical trial.\n2. Provided written informed consent.\n3. Confirmed chronic hepatitis B virus (HBV) infection (CHB) that fulfills the following criteria:\n\n   * HBsAg positive for ≥ 6 months\n   * Anti-HBs negative\n   * HBsAg levels 100-2000 IU\u002FmL\n   * HBV nucleos(t)ide analog (NUC) treatment for ≥ 6 months\n   * HBV load \\\u003C 100 IU\u002Fml at least twice within the last 6 months\n4. Males and non-pregnant, non-lactating female with negative pregnancy test aged 18-70 years at time of informed consent.\n5. Apart from CHB no other clinically significant health problems as determined during medical history and physical examination and clinical laboratory results at the screening visit. The following abnormal laboratory parameters will be permitted:\n\n   * leukocyte count ≥ 2.500\u002Fµl\n   * platelet count ≥ 150.000\u002Fµl\n   * ALT elevation ≤ 60 U\u002FL\n   * AST should be ≤ 40 U\u002FL\n   * bilirubin should be ≤ ULN\n   * INR should be ≤ ULN\n   * CrCL \\> 60mL\u002Fmin Non-clinically significant, minor deviations of laboratory measurements can be tolerated as they will not increase the risk of the individual having an adverse outcome from participating in this clinical trial as judged by the investigator.\n6. Subject may be on chronic or as needed medications if, in the opinion of the investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate worsening of a pre-existing medical condition.\n7. Body mass index 18.5-32.0 kg\u002Fm2 and weight \\>50 kg at screening.\n\nExclusion Criteria:\n\n1. Known liver disease other than hepatitis B\n2. Advanced liver fibrosis or cirrhosis (demonstrated by ultrasound or transient elastography ≥8 kP in fasting condition)\n3. WOCBP who don't agree to comply with the applicable contraceptive requirements of the protocol\n4. History of hepatocellular carcinoma\n5. Coinfection with Hepatitis C Virus (HCV) (RNA positive), Human Immunodeficiency Virus (HIV) or Hepatitis Delta virus (anti-Delta positive)\n6. Regular alcohol intake \\>30 g\u002Fd (male), \\>20 g\u002Fd (female) or any other known drug addiction.\n7. Donation of blood or blood products (e.g., 450 mL or more of plasma or platelets) within 60 days prior to receiving the first dose of the investigational medicinal product (IMP).\n8. Receipt of any vaccine in the 2 weeks prior to first trial vaccination (4 weeks for live vaccines), during trial or planned receipt of any vaccine in the 3 weeks following last trial vaccination. Exception: Required recommended pandemic vaccines or emergency vaccines (e.g., tetanus) are allowed.\n9. Previous receipt of an MVA based vaccine (e.g. as part of previous MVA studies, monkeypox or smallpox vaccination)\n10. Known allergy to components of the vaccine products as referred in Table 6 (incl. hypersensitivity to yeast components, E.coli proteins or lipids, duck's or hen's egg white, penicillin, streptomycin, , kanamycin) or history of life-threatening reactions to vaccines containing one of the substances.\n11. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.\n12. Clinically relevant findings in ECG or significant thromboembolic events in medical history.\n13. Evidence for a condition in the subject's medical history or during medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of vaccine products.\n14. Administration of immunoglobulins and\u002For any blood products within the 3 months preceding the administration of the first dose of the trial vaccine.\n15. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 3 years.\n16. Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to systemic corticosteroids, biologicals and Methotrexate) within the last 3 years. Exception: topical corticosteroids, e.g. occasional asthma spays or systemic corticosteroids for medical emergencies.\n17. Any chronic or active neurologic disorder, including diagnosis of migraine, seizures and epilepsy. Exception: a febrile seizure as a child and occasional headaches.\n18. Participation in a clinical investigation within the past 4 weeks or five times the half-life of the previously taken IMP.\n19. Investigator or employee of the study site with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, natural or adopted child) of the investigator or employee with direct involvement in the proposed study.\n20. Subjects who are known or suspected\n\n    * not to comply with the clinical trial directives.\n    * not to be reliable or trustworthy.\n    * not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed.","18 Years","70 Years",{"count":50,"type":20},81,"INTERVENTIONAL",[53,54],"PHASE1","PHASE2","This study is an open-label, ascending dose phase 1b\u002F2a trial to assess the safety and immunogenicity of a heterologous protein prime\u002FMVA boost therapeutic hepatitis B vaccine in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.",[57],"Chronic Hepatitis B","2026-06-09",{"date":60,"type":30},"2026-06-11",{"date":62,"type":30},"2025-06-12",{"date":64,"type":20},"2026-12",{"name":66,"class":37},"Michael Hoelscher",6,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":51,"phases":78,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100643778","phase-2-a-study-to-evaluate-ahb-137-injection-in-treatment-nave-participants-with-chronic-hepatitis-b-100643778","NCT07635186","A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B.","Inclusion Criteria:\n\n* Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol.\n* Aged 18-65 years (including boundary values).\n* Body mass index between the range of 18-32 kg\u002Fm2 (inclusive boundary values).\n* HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue.\n* HBsAg and HBV DNA values met protocol requirements at screening.\n* ALT \\\u003C 3xULN at screening.\n* Use highly effective contraception as required.\n\nExclusion Criteria:\n\n* Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection.\n* Participants with other clinically significant liver diseases, previous\u002Fcurrent manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status.\n* Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization.\n* Hepatitis C virus (HCV) infection or \\\u003C 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive).\n* Significant fibrosis or cirrhosis, or liver stiffness value (LSM) \\> 9.0 kPa at screening.\n* Participants with confirmed or suspected liver cancer who have a history of malignancy within the past 5 years or are undergoing assessment for a possible malignancy.\n* Laboratory test results do not meet the criteria.\n* Prior\u002Fcurrent autoimmune disease, history of vasculitis, or presence of signs, symptoms, or laboratory tests of underlying vasculitis.\n* Fridericia ' s formula corrected QT interval (QTcF) ≥ 450 msec for male participants and ≥ 470 msec for female participants at screening.\n* Allergic to AHB-137 ingredients, or history of drug allergy or other allergies.\n* Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial.\n* Participants are participating in another clinical trial or failing to wash out as required.\n* Current use or use of any immunosuppressive medication (e.g. prednisone) within 3 months prior to screening, except for short courses (≤ 2 weeks) or use of topical\u002Finhaled steroids;Those who have used immunomodulators within 3 months prior to screening;Those who have used cytotoxic drugs within 6 months prior to screening;History of vaccination within 1 month prior to screening or a live vaccination plan during the trial.\n* Participants that require regular long-term anticoagulants.\n* Abnormal thyroid function.\n* Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B.\n* Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial.","65 Years",{"count":77,"type":20},320,[54],"This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.",[57],[57],"NOT_YET_RECRUITING","2026-06-03",{"date":58,"type":30},{"date":86,"type":20},"2026-06-20",{"date":88,"type":20},"2028-06-20",{"name":90,"class":91},"Ausper Biopharma Co., Ltd.","INDUSTRY",2,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":75,"enrollmentInfo":100,"targetDuration":4,"studyType":51,"phases":102,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":119},"100523185","phase-2-vir-2218-and-peginterferon-alfa-2a-for-chronic-hepatitis-b-100523185","NCT06092333","VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B","A Pilot Study of the Combination of VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age \\>=18-65 years\n2. HBsAg positive with a level \\\u003C2,000 IU\u002FmL at the time of screening\n3. Hepatitis B e antigen negative\n4. HBV DNA levels \\\u003C10,000 IU\u002FmL on two occasions at least 24 weeks apart with the second being at time of screening\n5. ALT level \\\u003C=2 ULN (using sex-specific cut-offs of normal 35 U\u002FL for males and 25 U\u002FL for females) based on at least two determinations taken at least 24 weeks apart with the second being at time of screening\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnancy or lactation\n2. For women of childbearing potential, inability, or unwillingness to use highly effective contraception during study drug dosing and for an additional 24 weeks after the end of study drug administration.\n3. For males of reproductive potential: Unable or unwilling to use condoms consistently in addition to female partner using another adequate contraceptive method to ensure effective contraception with partner during study participation and for an additional 24 weeks after the end of study medication administration. Patients who have underwent surgical sterilization (vasectomy) will still require female partner to utilize an additional adequate contraception method.\n4. Known history of hypersensitivity or contraindication to an siRNA, oligonucleotide, or GalNAc or any interferon product\n5. Current use of oral theophylline and methadone\n6. Any treatment for HBV within the last 24 weeks\n7. Prior exposure to a siRNA\n8. Co-infection with HDV as defined by the presence of anti-HDV in serum.\n9. Co-infection with HCV as defined by the presence of anti-HCV and HCV RNA in serum.\n10. Co-infection with HIV as defined by the presence of anti-HIV in serum\n11. Cirrhosis either diagnosed by a prior liver biopsy at any time or, if not available, by a transient elastography score \\>13 kPa\n12. Decompensated liver disease as defined by serum bilirubin \\>2.5 mg\u002FdL (with direct bilirubin \\> 1.5 mg\u002FdL), prothrombin time of greater than 2 seconds prolonged, a serum albumin of less than 3.5 g\u002FdL, or a history of ascites, variceal bleeding or hepatic encephalopathy\n13. Hepatocellular carcinoma (HCC), or the presence of a mass on imaging studies of the liver that is suggestive of HCC, or an alpha-fetoprotein level of greater than 500 ng\u002FmL\n14. Presence of other causes of liver disease, (i.e. hemochromatosis, Wilson disease, alcoholic liver disease, severe steatosis, alpha-1-anti-trypsin deficiency)\n15. A history of solid organ or bone marrow transplant\n16. Any current medical condition requiring the chronic use of more than 10 mg of prednisone (or its equivalent) daily or biologics (e.g. monoclonal antibody, interferon) within 3 months of screening.\n17. Significant systemic illness other than liver diseases including congestive heart failure, renal failure, chronic pancreatitis and diabetes mellitus with poor control (hemoglobin A 1C (HgbA1C \\>8.5)), that in the opinion of the investigator may interfere with therapy.\n18. eGFR \\\u003C 60 ml\u002Fmin, serum creatinine \\> 1.3 mg\u002Fdl\n19. Platelet count \\\u003C90 mm3\u002FdL\n20. Hgb \\\u003C12 g\u002FdL for males and \\\u003C11 g\u002FdL for females\n21. White Blood cell count \\\u003C 2500 cells\u002Fmm3\n22. Neutrophil count \\\u003C 1500 cell\u002Fmm3 (or \\\u003C 1000 cell\u002Fmm3 if considered a physiological variant in a subject of African descent)\n23. Active ethanol\u002Fdrug abuse\u002Fpsychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study.\n24. History of malignancy or treatment for a malignancy within the past 3 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin).\n25. History of immune-mediated disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis, sarcoidosis, psoriasis of greater than mild severity, autoimmune uveitis), or cerebrovascular, chronic pulmonary or cardiac disease associated with functional limitation, retinopathy, uncontrolled thyroid disease, (TSH \\>10 or \\\u003C0.4mU\u002FL) or uncontrolled seizure disorder, as determined by a study physician.\n26. Use of another investigational agent within 90 days of screening\n27. Use of any prohibited immunosuppressants (except short term use of prednisone as a steroid burst \\[\\\u003C= 1 week of use\\]) or cytotoxic medications\n28. Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study.\n29. Inability of subject to understand and the unwillingness to sign a written informed consent document",{"count":101,"type":20},50,[54],"Background:\n\nChronic hepatitis B virus (HBV) infection affects 292 million people worldwide; 887,000 die each year from cirrhosis, liver cancer, and related issues. Treatment options are limited.\n\nObjective:\n\nTo test 2 drugs (VIR-2218 and peginterferon) in people with mild or inactive HBV infection.\n\nEligibility:\n\nPeople aged 18 to 65 years with mild or inactive HBV infection.\n\nDesign:\n\nParticipants will be screened. They will have blood tests and an eye exam. They will have imaging scans of the liver to check the health of the liver.\n\nParticipants will be in the study for over 2 years.\n\nVIR-2218 is an injection given under the skin of the stomach, upper arm, or thigh. Participants will come to the clinic to receive this injection once a month for 6 months.\n\nPeginterferon is also injected under the skin. Participants will have this shot once a week for 6 months. They may either inject themselves at home or come to the clinic to get the injections.\n\nParticipants will get just the VIR-2218 for 3 months, then both shots for 3 months, then just the peginterferon for 3 months.\n\nParticipants will have two 3-day stays in the hospital. Tests will include:\n\nLiver biopsy. A sample of tissue will be taken from their liver. After the procedure, participants will lie on their right side for 2 hours and then on their back for 4 hours.\n\nFine needle aspiration. A small needle will be used to collect cells from the liver.\n\nAfter the last injection of peginterferon, follow-up visits will continue in the outpatient clinic every 4 to 12 weeks.",[57],[57,106,107,108],"Treatment","Functional Cure","Immune Response","2026-05-28",{"date":111,"type":30},"2026-05-29",{"date":113,"type":30},"2025-01-31",{"date":115,"type":20},"2028-08-31",{"name":117,"class":118},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":75,"enrollmentInfo":127,"targetDuration":4,"studyType":51,"phases":129,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":119},"100598290","phase-2-a-multicenter-study-of-ahb-137-injection-combined-with-other-hepatitis-b-drugs-100598290","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.",{"count":128,"type":20},200,[54],"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.",[57],[133],"Hepatitis B, Chronic","2026-05-18",{"date":136,"type":30},"2026-05-20",{"date":138,"type":30},"2025-06-08",{"date":140,"type":20},"2028-01-15",{"name":90,"class":91},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":16,"minAge":47,"maxAge":75,"enrollmentInfo":149,"targetDuration":4,"studyType":51,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":119},"100640483","phase-1-a-clinical-study-evaluating-the-pharmacokinetic-characteristics-and-safety-of-ahb-137-injection-in-participants-with-mild-to-moderate-liver-dysfunction-and-those-with-normal-liver-function-100640483","NCT07600788","A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function.","Inclusion Criteria:\n\n* Voluntarily participate in the study, sign an informed consent form before the study and be able to complete the study according to the requirements of the protocol;\n* At the time of signing the informed consent form, male or female participants aged 18-65 years (including threshold values);\n* Body mass index meets the criteria;\n* Take effective contraceptive measures as required;\n* Participants with liver function impairment need to meet certain liver function assessments;\n* Participants with normal liver function should meet certain age, weight, and gender requirements to match those with liver function impairment, and should also undergo certain physical and laboratory tests.\n\nExclusion Criteria:\n\n* Diagnosed or suspected liver cancer participants who have undergone liver transplantation;\n* History of vasculitis or presence of signs and symptoms of potential vasculitis or laboratory tests;\n* Unstable control of hypertension or diabetes, progressive nervous system disease, history of immune related extrahepatic diseases, and unstable cardiac function;\n* Participants with a history of malignant tumors or undergoing malignant tumor assessment;\n* Screening for participants who have undergone significant trauma or surgery within the previous 3 months, as well as those who plan to undergo surgery;\n* Participants with thyroid dysfunction who are not suitable for inclusion in the study;\n* Allergic or allergic constitution to AHB-137;\n* Long term regular receipt of anticoagulant or antiplatelet drugs is required;\n* Those who have received any antisense oligonucleotide drugs or have been treated with siRNA drugs or interferon within the 12 months prior to screening;\n* Currently using or using any immunosuppressive medication within the past 3 months prior to screening, except for short-term use or the use of topical\u002Finhaled steroids; Individuals who have used immunomodulators and cytotoxic drugs within the 6 months prior to administration;\n* Those who have a history of vaccination or a plan to receive live vaccines within one month before administration, those who have used creatine containing fitness supplements 14 days before administration, and those who have used albumin 14 days before administration;\n* HIV, Syphilis positive ;\n* Those who are participating in another clinical trial and have not been eluted as required;\n* Positive results in urine drug screening and alcohol breath screening tests during screening;\n* Those who drink excessively and consume prohibited foods and beverages before administration;\n* Participants who have donated blood (or lost blood) ≥ 400 ml, received whole blood, or used red blood cell suspension within the past 3 months prior to screening; Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection;\n* Long term regular vigorous exercise or intense exercise within 48 hours before screening;\n* Any other circumstances or conditions that the researcher deems unsuitable for the subject to participate in this study;\n* Diseases that need to be excluded according to the merger plan for patients with abnormal liver function;\n* The laboratory test results do not meet the requirements of the protocol;\n* Participants with normal liver function who have a history of chronic liver disease or known liver or biliary abnormalities;\n* Participants with normal liver function who have used traditional Chinese medicine or other systemic medications with potential liver toxicity 14 days before administration;\n* Participants with normal liver function and abnormal QTcF values.",true,{"count":150,"type":20},32,[53],"A clinical study evaluating the pharmacokinetic characteristics and safety of AHB-137 injection in participants with mild to moderate liver dysfunction and those with normal liver function.",[57],[155,156],"Hepatitis B","Chronic","2026-05-14",{"date":159,"type":30},"2026-05-22",{"date":161,"type":20},"2026-05-15",{"date":163,"type":20},"2028-05-15",{"name":90,"class":91},{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":148,"sex":16,"minAge":47,"maxAge":75,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":119},"100627473","adaptability-of-an-undetectable--untransmissible-model-for-hbv-100627473","NCT07449091","Adaptability of an Undetectable = Untransmissible Model for HBV","Adaptability of an Undetectable = Untransmissible Model for HBV: Are Suppressed Viral Levels in the Serum Consistent Across Body Fluid Reservoirs?","Inclusion Criteria:\n\nInfected Individuals\n\n* Individuals above 18 years and less than 65 years with chronic hepatitis B infection\n* Included according to undermentioned three arms:\n\n  * Infected, On-treatment arm: subjects being treated with TAF\u002FTDF for a minimum of 2 years with sustained viral suppression indicating adherence to therapy\n  * Infected, Untreated control arm: Immune tolerant subjects; 15 with high viral load (\\>10\\^6) and 5 with low viral load (\\\u003C10\\^6)\n  * Uninfected Assay Validation controls: 10 subjects with history of prior infection who have convalesced i.e., have lost surface antigen, and developed surface antibody with viral eradication\n* Able and willing to provide informed consent\n\nHealthy Controls\n\n* Individuals above 18 years and less than 65 years who have never been infected and have been vaccinated\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Individuals less than 18 years or greater than 65 years of age\n* Prior surgery to genitourinary tract, including prior vasectomy\n* Prior interferon therapy\n* HIV co-infection\n* Hepatitis C virus co-infection\n* Hepatitis delta virus co-infection",{"count":173,"type":20},55,"Persons with chronic hepatitis B (HBV) infection and active viremia are infectious and may transmit virus to others through blood\u002Fbody fluid exposure. Immune tolerant treatment naive persons with hepatitis B infection express anxiety regarding disclosure of their infection status and significant fear of transmission to their partners leading to social isolation and impact on their personal lives. This study will provide data correlating serum and body fluid viral levels in persons with chronic hepatitis B infection not on therapy and those with viral suppression on long-term anti-retroviral therapy (ART) that may support the concept of \"Undetectable=Untransmissible\" (U=U) in patients with chronic hepatitis B.",[25,176],"Viremia",{"date":161,"type":30},{"date":179,"type":30},"2026-05-01",{"date":181,"type":20},"2027-09",{"name":183,"class":37},"NYU Langone Health",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":51,"phases":194,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":92},"100634511","assessment-of-treatment-adherence-and-associated-factors-in-chronic-hepb-patients-supported-by-hbvcare-100634511","NCT07540637","Assessment of Treatment Adherence and Associated Factors in Chronic HepB Patients Supported by HBVCare","Assessment of Treatment Adherence and Associated Factors in Chronic Hepatitis B Patients With Supported Management by the HBVCare Application.","HBVCare","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of Chronic Hepatitis B (CHB): HBsAg (+) and\u002For HBV DNA positive for ≥ 6 months; Or HBsAg positive and anti-HBc IgM negative.\n* Smartphone ownership (iOS or Android) with an active internet connection and the ability to install the HBVCare application.\n* Sufficient literacy to read and understand Vietnamese and respond to study questions.\n* Provision of informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Mental health disorders, cognitive impairment, or difficulties in communication and mobile application usage.\n* Severe comorbid chronic conditions, such as heart failure, kidney failure, or respiratory failure.\n* Presence of severe complications, including gastrointestinal bleeding, liver cancer, hepatic encephalopathy, or acute liver failure.",{"count":193,"type":20},70,[195],"NA","Adherence to chronic Hepatitis B (HBV) treatment and regular follow-up visits is essential for preventing dangerous complications, yet adherence rates in Vietnam remain low due to barriers in patient awareness and geographic conditions. Digital health solutions, particularly mobile applications, have shown potential as tools for supporting patients in proactive disease management. The HBVCare mobile application was developed to provide features such as medication reminders, storage of lab results, and health education to improve treatment adherence and clinical outcomes. The investigators are conducting a multicenter, randomized controlled trial at Hoang Long Clinic and Hanoi Medical University Hospital to evaluate the effectiveness of HBVCare. Patients are randomized into either a control group receiving standard care and an intervention group using the HBVCare app, with patient adherence and related factors assessed after three months of treatment.",[57],[57,199,200,201],"Digital health","mobile application","medication adherence","2026-05-13",{"date":161,"type":30},{"date":205,"type":30},"2026-04-15",{"date":207,"type":20},"2026-12-31",{"name":209,"class":37},"Institute of Gastroenterology and Hepatology, Vietnam",{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":51,"phases":220,"briefSummary":221,"conditions":222,"keywords":224,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":235},"100637072","phase-1-safety-tolerability-pharmacokinetic-and-pharmacodynamic-characteristics-of-act500-in-participants-with-metabolic-dysfunction-associated-steatotic-liver-disease-complicated-with-chronic-hepatitis-b-100637072","NCT07589400","Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis B","A Multicenter, Randomized, Double-blind, Multiple Ascending Dose, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-associated Steatotic Liver Disease Complicated With Chronic Hepatitis B.","Inclusion Criteria:\n\n* The participant fully understands the purpose, nature, methods of the trial, and the potential adverse reactions, voluntarily agrees to participate in this study, and signs the informed consent form.\n* Male or female participants aged between 18 and 60 years (inclusive) at the time of signing the informed consent form.\n* Liver fat content ≥10% as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) during the screening period.\n* Liver stiffness measurement (LSM) by FibroScan during the screening period meets 8 kPa ≤ LSM \\\u003C 12 kPa, or liver biopsy results within 6 months prior to screening show stage F2\u002FF3 liver fibrosis.\n* Hepatitis B surface antigen (HBsAg) positive for \\>6 months at screening, or other evidence of chronic hepatitis B (CHB), with HBV DNA \\\u003C 20 IU\u002FmL.\n* Serum alanine aminotransferase (ALT) \\\u003C 5×ULN at screening.\n* Received nucleos(t)ide analog (NAs) therapy for at least 1 year prior to screening and are currently on stable NA therapy (including entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, and tenofovir amibufenamide). Stable NAs therapy is defined as receiving the same treatment regimen within 3 months prior to screening.\n* Have at least one of the following metabolic disease risk factors:\n\nBMI ≥24.0 kg\u002Fm\\^2, or waist circumference ≥90 cm (male) and ≥85 cm (female); Prediabetes: fasting blood glucose ≥6.1 mmol\u002FL, or glycated hemoglobin (HbA1c) ≥5.7%; History of type 2 diabetes mellitus; 1.70 mmol\u002FL ≤ fasting serum triglycerides \\\u003C 5.6 mmol\u002FL; Fasting serum high-density lipoprotein cholesterol ≤1.0 mmol\u002FL (male) and ≤1.3 mmol\u002FL (female), or receiving stable-dose lipid-lowering therapy; Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, with systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤100 mmHg; or receiving stable-dose antihypertensive therapy with systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤100 mmHg.\n\n* Both male and female participants must agree to use adequate contraceptive methods, where:\n\nMale participants: agree to use reliable contraceptive measures from the time of signing the informed consent form until 3 months after the last dose, and have no sperm donation plans; Female participants: women of non-childbearing potential; or women of childbearing potential who are not pregnant or breastfeeding, must have a negative serum pregnancy test result at screening and within 1 day prior to the first dose, agree to use reliable contraceptive measures from the time of signing the informed consent form until 3 months after the last dose, and have no oocyte donation plans.\n\nExclusion Criteria:\n\n* Concurrent other liver diseases, including but not limited to hepatitis C, hepatitis D, drug-induced liver disease, alcoholic liver disease, autoimmune liver disease, suspected or confirmed liver cancer, etc.\n* Participants with a previous or current history of other malignant tumors, liver cirrhosis (including imaging-confirmed or suspected cirrhosis, and liver biopsy-confirmed cirrhosis), or evidence of decompensated liver disease (such as ascites, esophagogastric variceal bleeding, hepatic encephalopathy), or with a history of liver transplantation.\n* Participants with a history or current symptoms of severe cardiovascular and cerebrovascular diseases, including but not limited to uncontrolled or severe arrhythmia (ventricular fibrillation, atrial fibrillation, etc.), myocardial infarction, coronary heart disease, uncontrolled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg).\n* Participants with persistent and clinically significant medical history of respiratory, nervous, gastrointestinal, immune, hematological or psychiatric diseases, which, in the opinion of the investigator, may impose additional risks on the participant.\n* Participants with type 1 diabetes or poorly controlled type 2 diabetes (fasting blood glucose \\>9 mmol\u002FL within 3 months prior to screening or glycated hemoglobin \\>9.5% at screening), or diabetic patients using hypoglycemic drugs other than metformin and insulin.\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m² (calculated by the CKD-EPI formula) at screening, or with a history of severe renal impairment.\n* Known hemoglobinopathy, hemolytic anemia, sickle cell anemia; or hemoglobin \\\u003C115 g\u002FL in female participants and \\\u003C130 g\u002FL in male participants at screening; or any other conditions judged by the investigator to interfere with hemoglobin detection.\n* Any of the following laboratory abnormalities at screening: alkaline phosphatase (ALP) \\>2 times the upper limit of normal (ULN), total bilirubin (TBIL) \\>1.5 times the ULN, international normalized ratio (INR) \\>1.3, albumin \\\u003C35 g\u002FL, platelet count \\\u003C125×10⁹\u002FL, and serum triglycerides \\>5.6 mmol\u002FL.\n* Participants with body weight gain or loss \\>5% within 3 months prior to screening, or those receiving diet control, bariatric surgery, or using approved anti-obesity medications for weight loss indications.\n* Participants with a history of major trauma or surgery within 3 months prior to screening, or those scheduled to undergo surgery during the study period.\n* Excessive alcohol consumption for 3 consecutive months or more within 1 year prior to screening. Excessive drinking is defined as weekly ethanol intake ≥210 g for males and ≥140 g for females; or with a history of drug abuse\u002Fdependence or drug inhalation\u002Finjection within 1 year prior to screening.\n* Use of drugs with potential therapeutic effects on MASLD\u002FMASH within 3 months prior to screening (e.g., GLP-1 receptor agonists, DPP4 inhibitors, SGLT2 inhibitors, FGF21 analogues, resmetirom, etc.), or drugs that may induce MASLD\u002FMASH (e.g., amiodarone, methotrexate, tetracyclines, tamoxifen, estrogen at doses exceeding hormone replacement therapy, anabolic steroids, valproic acid, and other known hepatotoxic drugs); use of drugs that may affect the efficacy of hepatitis B treatment within 6 months prior to screening (e.g., anti-HBV drugs other than NAs, interferons, systemic immunomodulators, hepatitis B vaccines, etc.), or any other medications deemed by the investigator to interfere with the study.\n* Participation in other clinical drug trials within 6 months prior to screening.\n* Any positive result for human immunodeficiency virus antibody (HIV-Ab), hepatitis C virus antibody (HCV RNA test is required if positive, with the value below the quantitative lower limit of the local study center), hepatitis D virus antibody, or treponema pallidum antibody during the screening period.\n* Participants with allergic reactions to excipients of ACT500 or drugs with similar chemical structures to ACT500, or other drug allergies deemed ineligible for study participation by the investigator.\n* Any other conditions that render the participant unsuitable for this study as determined by the investigator, or participants who are unable to complete the trial due to personal reasons after signing the informed consent form (ICF).","60 Years",{"count":219,"type":20},24,[53],"This study is a Phase Ib, multicenter randomized, double-blind, dose-escalation, placebo-controlled trial designed to evaluate the safety, tolerability, PK, and PD profiles of multiple-dose ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) complicated with chronic hepatitis B (CHB). The trial plans to enroll 24 participants with MASLD complicated with CHB across three dose cohorts initially, each consisting of 8 participants who will receive oral ACT500 tablets once daily.",[223,25],"Metabolic Dysfunction-associated Steatotic Liver Disease",[223,25,225,226],"ACT500","NM6606","2026-05-11",{"date":161,"type":30},{"date":230,"type":20},"2026-05-30",{"date":232,"type":20},"2027-06-30",{"name":234,"class":91},"Xiamen Amoytop Biotech Co., Ltd.",4,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":51,"phases":246,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":4},"100637428","phase-3-phase-iiib-extension-clinical-trial-of-efficacy-and-safety-of-gst-hg141-nairevir-combined-with-nas-in-chronic-hepatitis-b-100637428","NCT07588009","Phase IIIB Extension Clinical Trial of Efficacy and Safety of GST-HG141 (Nairevir) Combined With NAs in Chronic Hepatitis B","A Single-Arm, Open-Label, Multicenter Phase IIIB Extension Clinical Trial to Evaluate the Efficacy and Safety of GST-HG141 (Nairecovir) in Combination With Nucleos(t)Ide Analogs (NAs) in Patients With Chronic Hepatitis B","Inclusion Criteria:\n\n1. Participants who received the study treatment of the phase III clinical trial of GST-HG141 (GST-HG141-III-01) in accordance with the protocol requirements (participants without early withdrawal and with overall medication compliance ≥ 80%), and had ALT ≤ 5×ULN;\n2. Participants were willing to participate in the study and were judged by the investigator to be suitable for long-term treatment with GST-HG141 combined with NAs;\n3. Male participants with female partners of childbearing potential or female participants of childbearing potential voluntarily adopted effective contraceptive measures from screening to 28 days after study withdrawal ;\n4. Signed the informed consent form prior to the trial and were able to complete the study in accordance with the requirements of the trial protocol.\n\nExclusion Criteria:\n\n1. Presence of severe systemic infection requiring treatment;\n2. Suffering from clinically significant acute or chronic liver diseases not caused by HBV infection;\n3. Participants with a history of liver cirrhosis; or currently diagnosed or suspected decompensated liver cirrhosis, including but not limited to hepatic encephalopathy, hepatorenal syndrome, esophagogastric variceal bleeding, splenomegaly, ascites, etc.; or participants with significant progression of liver fibrosis;\n4. Primary liver cancer; suspected malignant space-occupying liver lesions suggested by imaging examination; combined with other malignant tumors (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix);\n5. Impaired gastrointestinal function or gastrointestinal diseases that may affect the absorption of oral drugs as judged by the investigator;\n6. Combined with severe diseases of the circulatory, respiratory, urinary, hematological, metabolic, immune, psychiatric, neurological, renal and other systems, and judged by the investigator to be ineligible for continued participation in the study;\n7. Participants with major trauma or major surgery within 3 months prior to screening; or those planning to undergo surgery during the study period;\n8. Laboratory test abnormalities:\n\n   1. Platelet count \\\u003C 100×10\\^9\u002FL;\n   2. White blood cell count \\\u003C 3.0×10\\^9\u002FL;\n   3. Absolute neutrophil count \\\u003C 1.3×10\\^9\u002FL;\n   4. Serum total bilirubin \\> 2×ULN;\n   5. Albumin \\\u003C 35 g\u002FL;\n   6. Estimated glomerular filtration rate (eGFR) ≤ 60 ml·min-¹·(1.73m²)-¹ ;\n   7. International Normalized Ratio (INR) of prothrombin time \\> 1.5;\n9. Lactating females or participants with a positive pregnancy test;\n10. Participants with any other conditions deemed inappropriate for participation in this trial by the investigator.","71 Years",{"count":245,"type":20},576,[247],"PHASE3","This is a multicenter, single-arm, open-label, phase IIIb extension clinical trial designed to evaluate the long-term safety and tolerability of GST-HG141 (nerlecovir, 50 mg BID) in combination with nucleos(t)ide analogues (NAs) in patients with chronic hepatitis B (CHB) who completed 48 weeks of treatment in the phase III study (GST-HG141-III-01), did not discontinue prematurely, had an overall medication compliance rate of ≥80%, and were willing to continue treatment.\n\nA maximum of 578 eligible participants will be enrolled at 64 centers, including those who completed the preceding study, had ALT ≤5× upper limit of normal (ULN), and had no severe comorbidities (e.g., decompensated cirrhosis, other viral infections, or malignant tumors)",[25],"2026-05-08",{"date":157,"type":30},{"date":253,"type":20},"2026-06-26",{"date":255,"type":20},"2028-03-01",{"name":257,"class":91},"Fujian Akeylink Biotechnology Co., Ltd.",{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":264,"targetDuration":4,"studyType":51,"phases":266,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":276,"locationsCount":119},"100638849","phase-4-asc22-combined-with-peg-ifna-in-achieving-functional-cure-in-patients-with-chronic-hepatitis-b-virus-infection-100638849","NCT07573943","ASC22 Combined With Peg-IFNa in Achieving Functional Cure in Patients With Chronic Hepatitis B Virus Infection","Inclusion Criteria:\n\n1. Body mass index (BMI) of 18 to 32 kg\u002Fm\\^2;\n2. Serum HBsAg\\\u003C100 IU\u002FmL;\n3. HBV DNA\\\u003C20 IU\u002FmL;\n4. HBeAg-negative.\n\nExclusion Criteria:\n\n1. A history of allergy, or who are suspected by the researcher to be allergic to the active ingredient of the drug under study or its excipients;\n2. Use of immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before enrollment, or vaccination of live attenuated vaccine within 1 month before enrollment;\n3. Acute infection within 2 weeks before enrollment which requires intravenous antibiotic treatment, or existing infection which requires anti-infection treatment when enrollment;\n4. Confirmed or suspected decompensated cirrhosis;\n5. Malignant tumors;\n6. Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune, mental, neurological, renal and other systems;\n7. Hepatitis C virus (HCV) antibody (+), HIV antigen\u002Fantibody (+), or treponema pallidum antibody (+) and rapid plasma regain (RPR) test (+);\n8. Female in suckling period or pregnancy test (+) during screening;\n9. Subjects who are considered by the researcher to have other factors that are not suitable for the study",{"count":265,"type":20},150,[267],"PHASE4","Exploring the safety and efficacy of the therapy combining immune checkpoint inhibitors (anti-PD-L1 monoclonal antibody, ASC22) and pegylated interferon alfa (Peg-IFNα) in patients with CHB. Exploring new combination therapeutic schemes for hepatitis B cure, and raising the overall clinical cure rate to more than 50% without screening specific advantageous groups.",[25],"2026-05-05",{"date":272,"type":30},"2026-05-07",{"date":274,"type":30},"2024-05-21",{"date":207,"type":20},{"name":277,"class":37},"The Second Affiliated Hospital of Chongqing Medical University",{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":75,"enrollmentInfo":285,"targetDuration":4,"studyType":51,"phases":287,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":119},"100603545","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-ahb-137-injection-in-participants-with-chronic-hepatitis-b-chb-100603545","NCT07137910","A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)","An Open-label, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B Previously Treated With Nucleos (t) Ide Analogues (NA)","Inclusion Criteria:\n\n* Voluntarily participate in the study and sign the informed consent form;\n* 18-65 years of age (including boundary values) ;\n* Body mass index met the requirements;\n* Participants with CHB who are HBsAg or HBV DNA positive for at least 6 months;\n* Meet the relevant requirements for prior medications;\n* HBsAg and HBV DNA and liver function indicators meet the requirements;\n* Effective contraception as required;\n\nExclusion Criteria:\n\n* Uncontrolled and stable clinically significant abnormalities other than a history of CHB infection;\n* Associated liver disease;\n* Any serious infection other than CHB infection requires intravenous anti-infective therapy;\n* HCV RNA positive, HIV antibody positive, syphilis positive;\n* Abnormal laboratory results;\n* Diseases associated with vascular inflammatory conditions;\n* QT interval corrected heart rate (Fridericia method) abnormal;\n* History of malignancy or ongoing assessment of possible malignancy;\n* History of allergies, or allergic constitution;\n* Participants with recent major trauma or major surgery, or planning surgery;\n* Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;\n* Prior\u002Fcurrent use of prohibited medications;\n* Inappropriate for participation in this trial as judged by the investigator.",{"count":286,"type":20},60,[54],"This study is an open-label, multicenter phase II clinical study to evaluate the efficacy and safety of AHB-137 injection in participants with CHB previously treated with NA.",[57],[133],{"date":292,"type":30},"2026-05-04",{"date":294,"type":30},"2025-09-04",{"date":296,"type":20},"2027-06-01",{"name":90,"class":91},{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":92},"100604175","long-term-follow-up-study-to-evaluate-participants-with-chronic-hepatitis-b-chb-previously-treated-with-ahb-137-injection-100604175","NCT07146100","Long-term Follow-up Study to Evaluate Participants With Chronic Hepatitis B (CHB) Previously Treated With AHB-137 Injection","Prospective, Open-label, Multicenter Long-term Follow-up Study to Evaluate the Durability of Virologic Response in Participants With Chronic Hepatitis B Previously Treated With AHB-137 Injection","Inclusion Criteria:\n\n* Capable of giving informed consent.\n* Participants who have previously received at least one dose of AHB-137 and achieved the complete of partial response in the parent study without rescue medication and who maintained response until the End of Study (EoS) visit in their parent study.\n\nExclusion Criteria:\n\n* Participants who have\u002For are currently participating in another interventional clinical study since completing their treatment with AHB-137.\n* Suspected for cancer at screening or any condition required hospitalization during this study , or any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.",{"count":128,"type":20},"This study is a prospective, open-label, multicenter long-term follow-up study to evaluate the durability of virologic response in subjects with chronic hepatitis B previously treated with AHB-137 injection.",[57],[133],{"date":292,"type":30},{"date":311,"type":30},"2025-08-28",{"date":313,"type":20},"2030-01-01",{"name":90,"class":91},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":51,"phases":325,"briefSummary":326,"conditions":327,"keywords":328,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":119},"100519710","fine-needle-aspiration-fna-evaluation-of-the-intrahepatic-hbv-reservoir-and-its-immunological-characteristics-in-chronically-hbv-infected-patients-100519710","NCT06047093","Fine Needle Aspiration (FNA) Evaluation of the Intrahepatic HBV Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients","Evaluation of the Intrahepatic Hepatitis B Virus Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients - Pilot Study","RES-HBV","Inclusion Criteria:\n\n* Adult patients (≥ 18 years of age)\n* Patients chronically infected with hepatitis B virus at any stage of infection\n* Nucleoside Analogues-treated or untreated\n* Co-infected or not with HDV\n* Included in the prospective CirB-RNA study (part of the CirB-RNA university research program) (ID-RCB : 2018-A02558-47, NCT03825458)\n* Patient informed of the study and having signed a consent form\n\nExclusion Criteria:\n\n* Pregnant, parturient or breast-feeding women,\n* Patients with decompensated cirrhosis\n* Patients with hepatocellular carcinoma (suspected or proven),\n* Liver transplant patients (even if liver transplantation for HBV),\n* Patients co-infected with HCV (positive serum viral load) and\u002For HIV (regardless of serum viral load).\n* Patients participating at the time of inclusion in an interventional study\n* Persons under psychiatric care,\n* Persons admitted to a health or social institution for purposes other than research\n* Adults under legal protection (legal guardianship, tutorship, curatorship)\n* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme.\n* Patients with abdominal skin lesions and\u002For infections.\n* Contraindication to lidocaine administration (allergy or hypersensitivity to the product).",{"count":324,"type":20},100,[195],"Two hundred and ninety-six million people worldwide are chronically infected with the hepatitis B virus (HBV), with around 750,000 deaths each year linked to the development of cirrhosis or hepatocellular carcinoma. Current treatments based on nucleoside analogues (NA) achieve virological cure in only 5% of cases at 10 years. The virological persistence of HBV is explained by the persistence of cccDNA (covalently-closed circular DNA) in the nucleus of hepatocytes. Complex and poorly understood interactions between immunological and virological responses explain the persistence of ccccDNA. A better understanding of the immunological and virological interactions of the intrahepatic compartment during chronic HBV infection is needed to better understand the mechanisms of viral persistence and for research and development of new drugs to achieve the goal of a functional cure for HBV (defined as the prolonged loss of Hepatitis B surface antigen (HBsAg) after cessation of treatment, associated with a decrease in intrahepatic cccDNA or its transcriptional inactivation).\n\nThe intra-hepatic compartment can be explored by liver biopsy. A fine needle aspiration (FNA) technique is used to characterize primary hepatic tumors, with fewer complications than liver biopsy. One study has validated its use for immunological exploration of the intra-hepatic compartment. Finally, a recently published study confirms a correlation between FNA and liver biopsy virological markers in patients with chronic HBV infection. However, no combined immuno-virological study has been carried out to explore this intra-hepatic compartment by FNA in patients with chronic HBV infection.\n\nThe investigators will assess the intrahepatic compartment of patients chronically infected with HBV (+\u002F- hepatitis Delta (HDV)) to understand the mechanisms of viral persistence and characterize host immune responses to HBV. These investigations will make it possible to determine the immuno-virological profiles of patients who would benefit from intensification of antiviral treatment or, potentially, discontinuation of antiviral therapy.",[25],[155,329,330,331,332,333],"HBV","cccDNA","functional cure","FNA","HBsAg","2026-04-20",{"date":336,"type":30},"2026-04-21",{"date":338,"type":30},"2024-03-08",{"date":340,"type":20},"2030-03-08",{"name":342,"class":37},"Hospices Civils de Lyon",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":75,"enrollmentInfo":350,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":119},"100634261","a-study-on-the-pursuit-of-sustained-clearance-of-hbsag-in-chronic-hepatitis-bchb-patients-with-previous-interferon-treatment-using-pegylated-interferon-alpha-100634261","NCT07537387","A Study on the Pursuit of Sustained Clearance of HBsAg in Chronic Hepatitis B(CHB) Patients With Previous Interferon Treatment Using Pegylated Interferon Alpha","A Prospective, Non-Randomized, Multicenter Study of Peginterferon Alfa for Pursuing Sustained Hepatitis B Surface Antigen(HBsAg) Clearance in Interferon-Pretreated Patients With Chronic Hepatitis B","Inclusion Criteria:\n\n* • Voluntary participation and ability to understand and provide written informed consent.\n\n  * Age 18-65 years (inclusive), either gender.\n  * Documented HBsAg positivity for at least 6 months, or other evidence confirming chronic hepatitis B (CHB).\n  * Prior interferon therapy before enrollment (treatment discontinuation ≥ 3 months), with HBsAg level at the end of prior treatment reduced by ≥ 50% from baseline.\n  * HBsAg ≤ 500 IU\u002FmL at screening, and HBsAg rebound at screening not exceeding 50% of the baseline HBsAg level during the first-round interferon therapy.\n  * Negative pregnancy test within 24 hours prior to the first dose (for women of childbearing potential); all subjects (male and female) must use effective contraceptive measures during the study.\n\nExclusion Criteria:\n\n* • Pregnant or lactating women, or subjects with a pregnancy plan during the study period.\n\n  * Subjects with neuropsychiatric disorders, in particular a history of depression, anxiety, mania, schizophrenia, or a family history of psychiatric disorders (especially a history of depression or depressive tendency).\n  * Concurrent active infection with hepatitis A, hepatitis C, hepatitis E and\u002For HIV, or chronic liver disease due to other causes (e.g., alcoholic hepatitis, drug-induced liver injury, autoimmune liver disease, etc.).\n  * Evidence of acute severe liver damage: e.g., ALT \\> 10 × ULN, or marked ALT elevation accompanied by significant hyperbilirubinemia.\n  * Evidence of decompensated liver disease: e.g., ascites, esophagogastric variceal bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or prior evidence of decompensated cirrhosis.\n  * Evidence of hepatocellular carcinoma (HCC), or AFP \\> 1 × ULN.\n  * Renal diseases: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc.; or serum creatinine \\> 1 × ULN at screening.\n  * Neutrophil count \\\u003C 1.5 × 10⁹\u002FL, platelet count \\\u003C 90 × 10⁹\u002FL, or serum phosphorus \\\u003C 0.8 mmol\u002FL during the screening period.\n  * Autoimmune diseases (e.g., psoriasis, systemic lupus erythematosus, etc.), endocrine disorders (e.g., thyroid diseases, diabetes, etc.), hypertension poorly controlled by prescription medications (blood pressure ≥ 140\u002F90 mmHg), a history of severe heart disease (especially poorly controlled within 6 months), severe retinopathy or other serious ophthalmologic diseases, or other organic lesions or dysfunction of vital organs.\n  * Subjects planning to undergo or having previously undergone organ transplantation.\n  * Subjects with hypersensitivity to the investigational product or its excipients, or meeting any contraindication listed in the prescribing information of the investigational product.\n  * Other conditions deemed inappropriate for enrollment by the investigator",{"count":351,"type":20},10000,"This is a real-world, prospective, multicenter, non-randomized, controlled study. It aims to investigate the efficacy and safety of pegylated interferon α-2b (PEG IFN α-2b) monotherapy versus its combination with nucleos(t)ide analogs (NAs) regarding hepatitis B surface antigen (HBsAg) clearance in interferon-experienced patients with chronic hepatitis B (CHB). Subjects will receive either interferon-based therapy or NAs monotherapy based on their personal willingness and physicians' professional recommendations, with a uniform 48-week treatment course for all enrolled patients.",[25],[355,356,357],"CHB","Peginterferon","retreatment",{"date":359,"type":30},"2026-04-17",{"date":361,"type":20},"2026-04-30",{"date":363,"type":20},"2030-12-31",{"name":365,"class":37},"xieqing",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":51,"phases":376,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":388,"leadSponsor":390,"locationsCount":119},"100632933","union-fast-an-intelligent-agent-intervention-to-increase-antiviral-treatment-uptake-in-diagnosed-but-untreated-hepatitis-b-patients-100632933","NCT07520123","Union-FAST: An Intelligent-Agent Intervention to Increase Antiviral Treatment Uptake in Diagnosed-but-Untreated Hepatitis B Patients","Union-FAST: An Intelligent-Agent Intervention to Increase Antiviral Treatment Uptake in Diagnosed-but-Untreated Hepatitis B Patients：A Multicenter Prospective Study","Union-FAST","Inclusion Criteria:\n\n* Aged ≥18 years with persistent HBsAg positivity for ≥6 months (diagnosed as chronic hepatitis B \\[CHB\\] per the latest Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B).\n* Treatment-naïve to nucleos(t)ide analogues (NUCs), or previous NUC treatment with no medication for the past 6 months (diagnosed-but-untreated \\[DBU\\] status).\n* Capable of using a smartphone independently or with family member assistance.\n* Voluntarily provides written informed consent (electronic version) and agrees to study procedures and follow-up.\n\nExclusion Criteria:\n\n* Severe mental or cognitive impairment that impairs study cooperation.\n* Current participation in other interventional clinical trials that may influence HBV treatment decisions.\n* Inability to use a smartphone even with assistance.\n* Refusal to sign the informed consent form.",{"count":375,"type":20},2000,[195],"The World Health Organization (WHO) has set a target to eliminate viral hepatitis by 2030, aiming for a 90% diagnosis rate and an 80% treatment rate for chronic hepatitis B (CHB). However, as of 2024, only 26.1% of CHB infections globally have been diagnosed, and only 14.6% have received treatment, with treatment coverage falling far short of the target. A large number of patients are in a \"Diagnosed-but-Untreated (DBU)\" state, with major barriers including: low disease awareness, concerns about medication side effects, fragmented healthcare pathways, and poor physician-patient communication. Traditional hospital-based follow-up models are constrained by human resources and the capacity for health information system integration, making them difficult to scale widely in primary care settings.\n\nSupported by the National Key R\\&D Program of China, our team has successfully developed the world's first infectious disease agent (Union-Agent) after more than two years of research. This study aims to conduct a multicenter, prospective, two-cohort observational and interventional investigation to identify the reasons why DBU patients fail to initiate treatment and to explore whether an intervention using the Union-Agent can significantly increase the rate of antiviral treatment initiation within six months among DBU patients who meet the antiviral indications according to the 2022 Chinese guidelines for the prevention and treatment of chronic hepatitis B. The study hypothesizes that, compared to baseline, the Union-Agent can enable 50%-60% of treatment-eligible DBU patients to initiate antiviral therapy within six months.",[57],[380,381,382,383],"Agent Intelligence","chronic hepatitis B","hepatitis B virus","diagnosed-but-untreated","2026-04-06",{"date":386,"type":30},"2026-04-09",{"date":179,"type":20},{"date":389,"type":20},"2027-12-31",{"name":391,"class":37},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":412,"locationsCount":38},"100590399","hospital-based-management-of-patients-with-chronic-hepatitis-b-virus-infection-100590399","NCT06966908","Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection","Inclusion Criteria:\n\n* HBsAg-positive patients attending non-infectious disease\u002Fhepatology departments at three study centers.\n\nAdditional inclusion criteria for the PRO sub-study:\n\n* Age ≥ 18 years;\n* Treatment-naïve HBV-infected patients;\n* Meet the treatment criteria according to the \"Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B\" (2022 version);\n* Be able to understand the study content, willing to participate, and sign the informed consent;\n* Have the ability to complete questionnaires independently or with assistance.\n\nExclusion Criteria:\n\n* HBsAg-positive patients already under regular follow-up in infectious disease\u002Fhepatology clinics.\n* Chronic HBV patients on regular antiviral treatment.\n\nAdditional exclusion criteria for the PRO sub-study:\n\n* History of chronic liver diseases other than chronic HBV infection, including but not limited to: alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, etc. Co-infection with HCV, HDV, or HIV. Presence of other severe conditions that may affect HRQoL (such as severe cardiovascular and cerebrovascular diseases, uncontrolled mental illnesses, malignant tumors, etc.);\n* Pregnant or lactating women;\n* Use of pegylated interferon during the study;\n* Failure to complete all follow-up visits;\n* Other conditions that the investigator deems inappropriate for participation.",{"count":399,"type":20},16300,"Since 2022, the Third Affiliated Hospital of Sun Yat-sen University has initiated the \"Hot Wave Project\", a comprehensive hepatitis B infection prevention and management system encompassing patient education, screening, referral, treatment, and follow-up. In 2024, this system was expanded to the Sixth Affiliated Hospital and the Fifth Affiliated Hospital of Sun Yat-sen University, transitioning into a multicenter, hospital-based cohort study on hepatitis B management.The primary objective of this study is to increase the referral rate of HBsAg-positive patients in non-hepatology\u002Fnon-infectious disease departments to 50%. The secondary objective is to improve the treatment rate of hepatitis B infected patients in non-hepatology\u002Fnon-infectious disease departments, particularly focusing on the diagnosed but untreated (DBU) population. Furthermore, this study aims to analyze the cost-effectiveness and clinical benefits of in-hospital hepatitis B screening and management strategies.In 2025, a Patient-Reported Outcomes (PRO) sub-study was added to the project to evaluate the impact of antiviral therapy on the Health-Related Quality of Life among a cohort of treatment-naïve patients with chronic hepatitis B.",[57],[57,403,404,405],"linkage to care","management","patient reported outcome","2026-04-02",{"date":408,"type":30},"2026-04-08",{"date":410,"type":30},"2025-01-03",{"date":389,"type":20},{"name":413,"class":37},"Third Affiliated Hospital, Sun Yat-Sen University",{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":51,"phases":423,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":119},"100544134","phase-4-sglt2i-to-prevent-of-liver-complications-in-patients-with-chb-and-diabetes-mellitus-100544134","NCT06364930","SGLT2i to Prevent of Liver Complications in Patients With CHB and Diabetes Mellitus","Sodium-glucose Co-transporter-2 Inhibitor (SGLT2i) to Prevent of Liver Complications in Patients With Chronic Hepatitis B and Diabetes Mellitus: a Double-blind, Randomised, Placebo-controlled Trial","Inclusion Criteria:\n\n1. Patients with chronic hepatitis B on ETV, TDF or TAF monotherapy for at least 12 months.\n2. Known or newly diagnosed type 2 diabetes mellitus (T2D), defined as HbA1c ≥5.7% or fasting blood sugar ≥5.6 mmol\u002FL, or random blood sugar ≥11.1 mmol\u002FL, or 2 hours sugar after oral glucose tolerance test ≥7.8 mmol\u002FL.\n3. Stable use of anti-diabetic drugs in the last three months.\n4. Presence of compensated advanced chronic liver disease (cACLD) with liver stiffness measurement \\>10.0 kPa, or significant portal hypertension (spleen stiffness measurement \\> 41.3 kPa), or presence any sign of portal hypertension (e.g. splenomegaly, ascites, varices)\n5. Aged 18 years old or above.\n6. Written informed consent obtained.\n\nExclusion Criteria:\n\n1. Patients with hepatitis C virus (HCV) infection as indicated by a positive antibody to HCV (anti-HCV) serology test.\n2. Patients with history of cirrhotic complications or hepatocellular carcinoma\n3. Patients with organ transplantation\n4. Patients receiving a SGLT2i\n5. Contraindications to SGLT2i due to renal insufficiency (GFR \\\u003C 45 mL\u002Fmin\u002F1.73m2)\n6. Poor glycaemic control with HbA1c \\>9.0%\n7. Use of multiple anti-diabetic drugs (3 or more)\n8. Change in anti-diabetic drugs in the last three months.\n9. Serious medical illnesses or malignancy\n10. Age \\\u003C 18 years\n11. No patient consents",{"count":422,"type":20},412,[267],"This is a five-year, double blinded, randomised trial of dapagliflozin versus placebo in patients with chronic hepatitis B and DM or IFG complicated with compensated advanced chronic liver disease (cACLD). 412 subjects will be recruited. Subject will be randomly assigned to receive dapagliflozin 10mg daily or dapagliflozin placebo one tablet daily for up to 5 years. After randomization, subject will be followed up at month 3, month 6 and then 6-monthly until 60 months (follow up ± 4 weeks from scheduled clinic visit is allowed). At each visit, drug compliance, physical examination, observed or reported adverse events will be assessed. 10ml of blood will be taken at each visit and transient elastography to assess fibrosis regression will be performed at 60th month or at withdrawal visit. You are discouraged to use (pegylated)-interferon, any other NA including lamivudine, adefovir, and telbivudine, another SGLT2i Empagliflozin (Jardiance), Dapagliflozin + Metformin XR (Xigduo).",[57],"2026-03-16",{"date":428,"type":30},"2026-03-18",{"date":430,"type":30},"2024-03-26",{"date":432,"type":20},"2031-03-30",{"name":434,"class":37},"Chinese University of Hong Kong",{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":442,"enrollmentInfo":443,"targetDuration":445,"studyType":21,"phases":4,"briefSummary":446,"conditions":447,"keywords":449,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":119},"100575959","mr-elastography-for-assessing-liver-fibrosis-in-chronic-hepatitis-b-100575959","NCT06779058","MR Elastography for Assessing Liver Fibrosis in Chronic Hepatitis B","Retrospective and Prospective Multi-center Clinical Study of Magnetic Resonance Elastography in Evaluating Hepatic Fibrosis in Chronic Viral Hepatitis B","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Confirmed CHB (laboratory, imaging and clinical tests)\n* MRE within 6 months before and after liver biopsy\n* Treatment-naïve\n* Child-Pugh Grade A (\\\u003C7 points)\n* Written informed consent in prospective follow-up cohort\n\nExclusion Criteria:\n\n* Patients with liver malignant tumor\n* Chronic hepatitis due to other causes (such as alcoholic hepatitis)\n* CHB combined with hepatitis C, hepatitis D, or HIV\n* Patients with biliary tract diseases\n* Contraindications of MRE examination, MRE failure\n* Poor pathological effect","80 Years",{"count":444,"type":20},600,"2 Years","How to construct a non-invasive, accurate, and convenient method to evaluate the severity of liver fibrosis (LF) is an important general problem in the management of patients with chronic hepatitis B (CHB). We plan to investigate the ability of magnetic resonance elastography (MRE) to grade fibrosis in chronic hepatitis B and apply to clinical longitudinal follow-up.",[57,448],"Liver Fibrosis",[450,451,452],"Magnetic resonance elastography","Liver stiffness","Antiviral therapy","2026-02-26",{"date":455,"type":30},"2026-02-27",{"date":457,"type":30},"2025-01-01",{"date":459,"type":20},"2026-12-01",{"name":461,"class":37},"Shengjing Hospital",{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":469,"targetDuration":4,"studyType":51,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":119},"100599920","phase-3-to-evaluate-the-efficacy-safety-and-population-pharmacokinetics-of-gst-hg141-in-patients-with-chronic-hepatitis-b-chb-who-have-an-inadequate-response-to-antiviral-drug-treatment-100599920","NCT07090759","To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment","A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Trial of GST-HG141（Neracorvir）for Combination Therapy (add-on) in Patients With Inadequate Response to Antiviral Drugs in Chronic Hepatitis B (CHB)","Inclusion Criteria:\n\n1. Male or female individuals aged 18-70 years (inclusive of the boundaries);\n2. Male weight ≥ 50 kg, female weight ≥ 45 kg, with a body mass index (BMI) within the range of 18-35 kg\u002Fm2 (inclusive of the boundaries);\n3. Have been continuously taking nucleoside analogues (entecavir \\[ETV\\], tenofovir disoproxil fumarate \\[TDF\\], emivirofavir \\[TMF\\], or propivirofavir \\[TAF\\]) for more than one year (with a break of less than one month in the past year), and are receiving treatment at the time of screening and agree to accept the treatment plan provided by this study during the study period;\n\n   \\* Have maintained the same NA monotherapy for more than 3 months before screening\n4. HBeAg positive, serum HBV DNA can be detected by high-sensitivity PCR, and HBV DNA \\> 50 IU\u002FmL;\n5. At the time of screening, ALT ≤ 5×ULN;\n6. Male participants with a fertile female partner or female participants of childbearing age who are willing to voluntarily take effective contraceptive measures from the time of screening until 28 days after the completion of the study ;\n7. Sign the informed consent form before the trial and be able to complete the study as required by the trial protocol.\n\nExclusion Criteria:\n\n1. History of life-threatening severe allergic reactions such as anaphylactic shock, or allergy to the active ingredients or excipients of the study drug as suspected by the investigator;\n2. Concomitant use of cytochrome P450 enzyme 3A4 (CYP3A4) inhibitors, inducers, or substrates within 28 days prior to screening;\n3. Systemic use of immunosuppressants, immunomodulators (interferon must be discontinued for more than 12 months), or cytotoxic drugs within 6 months prior to screening; or vaccination with live attenuated vaccines within 1 month prior to screening;\n4. Presence of acute infections requiring treatment prior to randomization;\n5. Clinically significant acute or chronic liver disease not caused by HBV infection, rendering the subject unsuitable for participating in the study as determined by the investigator;\n6. Subjects with a history of cirrhosis (e.g., subjects who have undergone pathological examination of liver tissue with a report indicating cirrhosis or those who have undergone endoscopy indicating esophageal or gastric varices); or subjects with currently diagnosed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal or gastric varices, splenomegaly, and ascites; or subjects with significant progression of liver fibrosis;\n7. Primary liver cancer; serum alpha-fetoprotein (AFP) greater than 20 μg\u002FL (or 20 ng\u002FmL) or DCP\\>40 mAU\u002FmL or imaging suggesting possible malignant lesions in the liver; concurrent other malignancies or history of other malignancies within the past 5 years (except for cured basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ);\n8. Presence of gastrointestinal impairment or gastrointestinal disease that may affect the absorption of oral medication in the judgment of the investigator, such as severe gastrointestinal diseases (peptic ulcer, erosive or atrophic gastritis), partial gastrectomy, Grade \\> 2 gastrointestinal symptoms at screening (e.g., nausea, vomiting, or diarrhea), etc.;\n9. Concurrent severe diseases of the circulatory, respiratory, urinary, hematologic, metabolic, immune, psychiatric, neurological, renal, or other systems, rendering the subject unsuitable for participating in the study as determined by the investigator.\n10. Subjects with major trauma or major surgery within 3 months prior to screening; or those who plan to undergo surgery during the study period;\n11. Laboratory tests:\n\n    1. Platelet count \\\u003C 100 × 109\u002FL;\n    2. White blood cell count \\\u003C 3.0 × 109\u002FL;\n    3. Absolute neutrophil count \\\u003C 1.3 × 109\u002FL;\n    4. Serum total bilirubin \\> 2× ULN;\n    5. Albumin \\\u003C 35 g\u002FL;\n    6. GFR ≤ 60 mL·min-1·(1.73 m2)-1 (calculated using the CKD-EPI formula);\n    7. International normalized ratio (INR) of prothrombin time \\>1.5;\n12. Positive for hepatitis C antibody, positive for HIV antigen\u002Fantibody, or positive for syphilis antibody with a positive RPR or TRUST test result;\n13. History of sustained alcohol abuse within the past 3 years (weekly alcohol intake \\> 14 units, where 1 unit of alcohol equals 1 bottle of 350 mL beer, 120 mL wine, or 30 mL of spirits at 40% alcohol content);\n14. History of drug dependence or substance abuse;\n15. Participation in clinical trials involving other investigational drugs or medical devices and receiving the investigational drug or using the medical device within 3 months prior to screening;\n16. Women who are breastfeeding or tested positive for pregnancy;\n17. Determined by the investigator to be unsuitable for this trial for any other reasons.",{"count":470,"type":20},526,[247],"This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GST-HG141 in patients with chronic hepatitis B who have an inadequate response to antiviral drug treatment.",[25],"2026-01-22",{"date":476,"type":30},"2026-01-23",{"date":478,"type":30},"2025-07-24",{"date":480,"type":20},"2027-03-01",{"name":257,"class":91},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":16,"minAge":489,"maxAge":490,"enrollmentInfo":491,"targetDuration":4,"studyType":51,"phases":492,"briefSummary":493,"conditions":494,"keywords":497,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":511,"locationsCount":4},"100619514","phase-4-entecavir-with-or-without-pegylated-interferon--2b-in-children-aged-3-6-years-with-immune-active-chronic-hepatitis-b-100619514","NCT07345611","Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Active Chronic Hepatitis B","Efficacy and Safety of Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3 to 6 Years With Chronic Hepatitis B in the Immune-Clearance Phase (B-Young-Cure-2): A Multicenter, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age between 3 and 6 (more than 3 but less than 7) years;\n2. Chronic HBV infection;\n3. Positive HBeAg;\n4. HBV DNA \\>1.0×10⁴ IU\u002FmL;\n5. Normal upper abdominal ultrasound without cirrhosis or hepatocellular carcinoma;\n6. ALT \\>40 U\u002FL.\n\nExclusion Criteria:\n\n1. Previous antiviral treatment for chronic HBV infection;\n2. Coinfection with hepatitis C, D, E, human immunodeficiency virus (HIV), Epstein-Barr virus, or cytomegalovirus;\n3. Previous or current evidence of hepatocellular carcinoma or cirrhosis;\n4. Coexistence of any other liver diseases such as autoimmune hepatitis, drug-induced liver injury or Wilson's disease;\n5. Coexistence of systemic\u002Fother organ disorders (for example with evidence of thyroid disorders);\n6. Hemoglobin level \\\u003C100 g\u002FL;\n7. Absolute neutrophil count \\\u003C1.0×10⁹\u002FL.;\n8. Platelet count \\\u003C125×10⁹\u002FL;\n9. Total bilirubin \\>1 ULN, i.e., 17.1 μmol\u002FL;\n10. Albumin level \\\u003C35 g\u002FL;\n11. Concurrent treatment with other drugs, including but not limited to nephrotoxic drugs, immune modulators, cytotoxic drugs, Chinese traditional medicine or supplements, nonsteroidal anti-inflammatory drugs, or steroids.","3 Years","6 Years",{"count":286,"type":20},[267],"This study aims to evaluate the efficacy and safety of entecavir monotherapy versus sequential entecavir plus pegylated interferon α-2b in achieving functional cure in immune-active, HBeAg-positive children aged 3-6 years with chronic hepatitis B.",[495,496,57],"Hepatitis B Virus Infection","Children",[496,498,499,500,156,501,502,503,504],"Efficacy","Immune clearance","Safety","Entecavir","Pegylated interferon α-2b","Functional cure","Hepatitis B virus","2026-01-07",{"date":507,"type":30},"2026-01-16",{"date":509,"type":20},"2026-01-11",{"date":363,"type":20},{"name":512,"class":37},"Qing-Lei Zeng",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":16,"minAge":489,"maxAge":490,"enrollmentInfo":520,"targetDuration":4,"studyType":51,"phases":522,"briefSummary":523,"conditions":524,"keywords":525,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":529,"leadSponsor":530,"locationsCount":4},"100619515","phase-4-entecavir-with-or-without-pegylated-interferon--2b-in-children-aged-3-6-years-with-immune-tolerant-chronic-hepatitis-b-100619515","NCT07345624","Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis B","Efficacy and Safety of Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3 to 6 Years With Immune-Tolerant Chronic Hepatitis B Virus Infection (B-Young-Cure-1): A Multicenter, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged 3-6 (more than 3 but less than 7) years;\n2. With chronic HBV infection;\n3. HBeAg-positive;\n4. HBV DNA \\>1.0×10⁷ IU\u002FmL;\n5. Normal upper abdominal ultrasound;\n6. ALT \\\u003C40 U\u002FL, HBsAg positivity, HBeAg positivity, and HBV DNA\\>1.0×10⁷IU\u002FmL for at least two times, with an interval of 6 months or more.\n\nExclusion Criteria:\n\n1. Previous antiviral treatment for chronic HBV infection;\n2. Coinfection with hepatitis C, D, E, human immunodeficiency virus (HIV), Epstein-Barr virus, or cytomegalovirus;\n3. Previous or current evidence of hepatocellular carcinoma or cirrhosis;\n4. Coexistence of any other liver diseases such as autoimmune hepatitis, drug-induced liver injury or Wilson's disease;\n5. Coexistence of systemic\u002Fother organ disorders (for example with evidence of thyroid disorders);\n6. Hemoglobin level \\\u003C100 g\u002FL.\n7. Absolute neutrophil count \\\u003C1.0×10⁹\u002FL;\n8. Platelet count \\\u003C125×10⁹\u002FL;\n9. Total bilirubin \\>1 ULN, i.e., 17.1 μmol\u002FL;\n10. Albumin level \\\u003C35 g\u002FL;\n11. Concurrent treatment with other drugs, including but not limited to nephrotoxic drugs, immune modulators, cytotoxic drugs, Chinese traditional medicine or supplements, nonsteroidal anti-inflammatory drugs, or steroids.",{"count":521,"type":20},80,[267],"This study aims to evaluate the efficacy and safety of entecavir monotherapy versus sequential entecavir plus pegylated interferon α-2b in achieving functional cure in immune-tolerant, HBeAg-positive children aged 3-6 years with chronic hepatitis B virus infection.",[495,496,57],[496,498,500,156,502,504,501,503,526],"Immune-tolerant",{"date":507,"type":30},{"date":509,"type":20},{"date":363,"type":20},{"name":512,"class":37},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":51,"phases":541,"briefSummary":542,"conditions":543,"keywords":546,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":38},"100567661","phase-1-phase-1b-open-label-study-of-tune-401-to-assess-safety-pk-and-pd-in-adults-with-chronic-hepatitis-b-100567661","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","75 Years",{"count":540,"type":20},36,[53],"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.",[544,25,545,329],"Chronic Hep B","Chronic Hepatitis",[547,548,355],"Tune-401","Tune-401-001","2026-01-02",{"date":551,"type":30},"2026-01-06",{"date":553,"type":30},"2024-11-29",{"date":555,"type":20},"2028-10-30",{"name":557,"class":91},"Tune Therapeutics, Inc.",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":16,"minAge":47,"maxAge":75,"enrollmentInfo":565,"targetDuration":4,"studyType":51,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":577,"locationsCount":119},"100616590","phase-3-a-small-sample-prospective-clinical-study-of-azvudine-tablets-to-promote-clinical-cure-in-patients-with-chronic-hepatitis-b-100616590","NCT07307586","A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B","A Small Prospective Clinical Study on Azvudine Tablets for Treating Chronic Hepatitis B.","Inclusion Criteria:\n\n* All subjects must meet the following criteria to be eligible for inclusion in the trial:\n\n  1. Meet the diagnostic criteria for viral hepatitis as outlined in the Chinese Medical Association's Hepatology Branch Guidelines for the Prevention and Treatment of Chronic Hepatitis B, with patients demonstrating sustained positivity for hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) for at least six months;\n  2. HBV DNA load \\> 20,000 copies\u002FmL and HBsAg \\\u003C 1,500 IU\u002FmL;\n  3. Serum alanine aminotransferase (ALT) \\> 2 times the upper limit of normal;\n  4. No prior antiviral therapy prior to hospital admission.\n\nExclusion Criteria:\n\n* All subjects meeting any of the following criteria shall be excluded from this study:\n\n  1. Individuals co-infected with other hepatotropic viruses, such as hepatitis A, C, D, or E viruses, or HIV;\n  2. Patients with concomitant liver metabolic disorders, cirrhosis, autoimmune-related diseases, or other chronic conditions;\n  3. Pregnant or breastfeeding women, or those planning pregnancy within one year;\n  4. Patients who have received or are currently undergoing antineoplastic therapy;\n  5. History of alcohol or substance abuse;\n  6. Patients currently taking therapeutic medications or health supplements;\n  7. Patients who participated in other clinical trials within 30 days prior to enrolment;\n  8. Patients with allergic constitutions or hypersensitivity to any drug or component used in this study;\n  9. Patients with gastrointestinal disorders that may impair drug absorption.",{"count":566,"type":20},120,[247],"Through regular monitoring of viral load, liver function and immune cell activity, the long-term efficacy of Adefovir in controlling HBV is precisely evaluated. By employing a dual mechanism of \"antiviral action plus immune activation\", it offers a novel therapeutic option for achieving clinical cure in chronic hepatitis B.",[57,570],"Azvudine","2025-12-15",{"date":573,"type":30},"2025-12-29",{"date":575,"type":30},"2025-09-01",{"date":389,"type":20},{"name":578,"class":37},"Zhigang Ren",{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":148,"sex":16,"minAge":47,"maxAge":75,"enrollmentInfo":586,"targetDuration":4,"studyType":51,"phases":587,"briefSummary":588,"conditions":589,"keywords":590,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":119},"100614155","phase-1-sa1211-injection-phase-1-study-100614155","NCT07275918","SA1211 Injection Phase 1 Study","A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SA1211 Injection in Healthy Participants and Participants With Chronic Hepatitis B","Inclusion Criteria:\n\n1. Able to correctly understand and sign the informed consent form in writing.\n2. Male or female participants.\n\n   * For healthy participants: aged 18-55 years old (inclusive of the cut-off values).\n   * For participants with chronic hepatitis B (CHB): aged 18-65 years old (inclusive of the cut-off values).\n3. Body Mass Index (BMI) meets the following requirements.\n\n   * For healthy participants: within the range of 18-28 kg\u002Fm² (inclusive of the cut-off values).\n   * For participants with chronic hepatitis B (CHB): within the range of 18-32 kg\u002Fm² (inclusive of the cut-off values).\n4. During the screening period, the results of the following examinations are either normal or abnormal but not clinically insignificant:\n\n   \\- Clinical laboratory tests: complete blood count, blood biochemistry, coagulation function, urine routine. Thyroid function test. 12-lead electrocardiogram (ECG). Abdominal ultrasound. Posteroanterior chest X-ray.\n5. For participants with chronic hepatitis B (CHB): documented hepatitis B virus (HBV) infection for at least 6 months before screening, with positive hepatitis B surface antigen (HBsAg) and\u002For positive HBV deoxyribonucleic acid (HBV DNA).\n6. For female participants of childbearing potential: must not be pregnant or lactating, and agree to use effective contraception during the study period.\n7. For male participants of childbearing potential: agree to use effective contraception during the study period to ensure effective contraception for their sexual partners.\n\nExclusion Criteria:\n\n1. Participants with concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV) or syphilis infection; or those previously diagnosed with hepatitis A, D, or E who have not been cured.\n2. Participants with severe diseases, including but not limited to diseases of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, thyroid, gastrointestinal, respiratory, metabolic, and skeletal systems, as well as a history of malignant tumors.\n3. Participants with severe mental illness or uncontrolled mental disorders, including but not limited to schizophrenia, bipolar disorder, or depression.\n4. Participants with a systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening, who are deemed unsuitable for the study by the investigator.\n5. Participants who have undergone major surgery within 6 months before screening, or plan to undergo surgery during the study period.\n6. Participants with severe infection or trauma within 4 weeks before screening.\n7. Participants with a severe allergic constitution, or a confirmed allergy to this product or its formulation components.\n8. Participants who smoked more than 5 cigarettes per day or the equivalent amount of tobacco within 3 months before screening.\n9. Participants deemed unsuitable for the trial by the investigator due to other factors.",{"count":521,"type":20},[53],"The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of SA1211 Injection in healthy volunteers (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in participants with chronic hepatitis B (CHB). The main questions it aims to answer are:\n\nWhat are the safety, tolerability, immunogenicity and PK characteristics of a single subcutaneous injection of SA1211 Injection in healthy volunteers (Part A)? What are the safety, tolerability, immunogenicity and PK characteristics of multiple subcutaneous injections of SA1211 Injection in participants with CHB (Part B)? What is the preliminary efficacy of SA1211 Injection in participants with CHB (Part B)?\n\nParticipants will:\n\n* Part A (healthy volunteers): Receive a single subcutaneous injection of SA1211 Injection or placebo and complete relevant safety, tolerability and PK monitoring as required.\n* Part B (participants with CHB): Receive multiple subcutaneous injections of SA1211 Injection or placebo and complete relevant safety, tolerability, PK monitoring and preliminary efficacy assessment as required.",[57],[355],"2025-12-08",{"date":593,"type":30},"2025-12-10",{"date":595,"type":30},"2025-11-25",{"date":597,"type":20},"2027-03-30",{"name":599,"class":91},"Suzhou Siran Biotechnology Co.,Ltd."]