[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hbv-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hbv-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,72,112,136,159],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100644760","phase-1-clinical-trial-to-evaluate-the-safety-tolerability-and-pharmacokinetic-profile-of-tvax-028-in-the-treatment-of-chronic-hepatitis-b-100644760",false,"NCT07673068","Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 in the Treatment of Chronic Hepatitis B","Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TVAX-028 Injection in Patients With Chronic Hepatitis B","Inclusion Criteria:\n\n* 1\\. Subjects voluntarily sign the informed consent, fully understand the study content, and are willing and able to comply with all trial procedures.\n* 2\\. Male or female, aged 18 to 65 years.\n* 3\\. Has a clinical diagnosis of chronic hepatitis B virus infection based on protocol-defined criteria.\n* 4\\. Is receiving stable antiviral treatment with a single nucleos(t)ide analogue before enrollment. Has adequately suppressed HBV DNA and acceptable liver function based on protocol-defined criteria before the first administration of adjuvant or TVAX-028.\n* 5\\. Has HBeAg-negative chronic hepatitis B virus infection based on protocol-defined criteria.\n* 6\\. Has hepatitis B surface antigen (HBsAg) levels within the protocol-defined range before the first administration of adjuvant or TVAX-028.\n* 7\\. Has no evidence of autoimmune liver disease based on protocol-defined testing and investigator assessment.\n* 8\\. Participants of childbearing potential must agree to use effective contraception for the protocol-defined period.\n\nExclusion Criteria:\n\n* 1\\. Has liver disease other than chronic hepatitis B virus infection that may interfere with study participation or interpretation of study results\n* 2\\. Has evidence or suspected evidence of hepatocellular carcinoma, cirrhosis, clinically significant hepatic space-occupying lesions, or clinically significant liver fibrosis based on imaging, laboratory testing, or non-invasive liver assessment.\n* 3\\. Has clinically significant abnormalities in laboratory tests, including but not limited to liver function, renal function, hematology, coagulation, or electrolyte parameters, based on protocol-defined criteria.\n* 4\\. Has received interferon or pegylated interferon treatment within the protocol-defined period before the first administration of adjuvant or TVAX-028, or plans to receive such treatment during the study.\n* 5\\. Has received immunosuppressive therapy within the protocol-defined period before the first administration of adjuvant or TVAX-028.\n* 6\\. Has received corticosteroid therapy within the protocol-defined period before the first administration of adjuvant or TVAX-028, except for permitted topical or inhaled corticosteroids.\n* 7\\. Has clinically significant cardiovascular, renal, pancreatic, or other systemic disease that may increase study risk or interfere with study assessments.\n* 8\\. Has inadequately controlled diabetes mellitus or hypertension based on protocol-defined criteria.\n* 9\\. Has evidence of clinically significant co-infection, including hepatitis C virus, hepatitis D virus, human immunodeficiency virus, or active syphilis infection.\n* 10\\. Has a history of malignancy within the protocol-defined period before the first administration of adjuvant or TVAX-028, except for conditions permitted by the protocol.\n* 11\\. Has previously received organ transplantation.\n* 12\\. Has a history of severe drug and food allergy, or is known to be allergic to any component of the investigational product or related products.\n* 13\\. Has a history of drug abuse or clinically significant alcohol abuse within the protocol-defined period before the first dose.\n* 14\\. Has a history or current diagnosis of psychiatric disease, severe depression, or other condition that may affect compliance with study procedures.\n* 15\\. Has a history of severe allergy, or is known or suspected to be allergic to any component of the investigational product, adjuvant, or related products.\n* 16\\. Has participated in another clinical trial of an investigational drug, biologic, medical device, or vaccine within the protocol-defined period before the first administration of adjuvant or TVAX-028.\n* 17\\. Is pregnant or breastfeeding.\n* 18\\. Is considered by the investigator to be unsuitable for participation in this study for any other reason.","ALL","18 Years","65 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a multicenter, open-label, non-randomized, Phase 1 clinical study with single-dose and multiple-dose dose-escalation cohorts. The study is designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of TVAX-028 in patients with chronic hepatitis B virus infection",[27],"HBV Infection","NOT_YET_RECRUITING","2026-06-24",{"date":31,"type":32},"2026-06-29","ACTUAL",{"date":34,"type":21},"2026-05-31",{"date":36,"type":21},"2027-05-31",{"name":38,"class":39},"Grand Theravac Life Sciences (Nanjing) Co., Ltd.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":47,"targetDuration":49,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100613358","single-cell-multiomics-and-spatiotemporal-omics-analyze-the-mechanism-of-liver-degenerative-disease-100613358","NCT07265544","Single-cell Multiomics and Spatiotemporal Omics Analyze the Mechanism of Liver Degenerative Disease","Inclusion Criteria:\n\n1. Voluntarily signed the informed consent form;\n2. No restrictions on age and gender;\n3. Patients diagnosed with hepatic hemangioma or focal nodular hyperplasia of the liver in accordance with the \"Guidelines for the Diagnosis and Treatment of Focal Liver Lesions (2014 Edition)\" and the \"Guidelines for the Diagnosis and Treatment of Hemangiomas and Vascular Malformations (2019 Edition)\";\n4. Patients with hepatic hemangioma, focal nodular hyperplasia of the liver, fatty liver, HBV infection, liver fibrosis, and cirrhosis who clinically require liver surgery or liver biopsy.\n\nExclusion Criteria:\n\n1. Individuals with concurrent infections such as HIV will be excluded.\n2. Patients with coagulation system disorders, such as hemophilia or idiopathic thrombocytopenic purpura, will not be included.\n3. Those with severe underlying diseases that affect the body's immune status will be excluded.\n4. Individuals whom the investigator deems unsuitable for participation in this study will be excluded.",true,{"count":48,"type":21},240,"7 Days","OBSERVATIONAL","The purpose of this observational study is to employ single-cell multi-omics and spatial omics technologies to characterize the spatial and immune structures within the livers of patients with fatty liver, hepatic hemangioma, focal nodular hyperplasia, liver fibrosis, cirrhosis, and HBV infection. The primary questions it aims to address are:\n\nInvestigate the mechanisms of liver degenerative changes during the processes of liver aging, fatty liver, HBV infection, liver fibrosis, and cirrhosis.\n\nCharacterize the molecular features and cellular networks at different stages of liver degeneration and identify new targets and mechanisms for the cure of the aforementioned diseases.\n\nThe study will collect peripheral blood and discarded liver tissue from patients with hepatic hemangioma, fatty liver, HBV infection, liver fibrosis, and cirrhosis who are undergoing hepatectomy or liver biopsy.",[53,27,54,55],"Liver Neoplasm","Non-alcoholic Fatty Liver Disease NAFLD","Liver Fibrosis",[57,58,59],"single-cell multi-omics","HBV infection","liver degenerative changes","RECRUITING","2026-04-13",{"date":63,"type":32},"2026-04-14",{"date":65,"type":32},"2023-03-01",{"date":67,"type":21},"2027-02-12",{"name":69,"class":70},"Nanfang Hospital, Southern Medical University","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":80,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":71},"100624695","pregnancy-and-viral-infections-impact-on-pregnant-women-and-their-children-french-prospective-cohort-100624695","NCT07412977","\"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort\"","\"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort.\"","VIROPREG","Inclusion Criteria:\n\nPregnant women :\n\n* Cis-gender pregnant woman wishing to carry her pregnancy to term and give birth in one of the maternity units participating in the research, whatever the term of pregnancy (inclusion as soon as possible after conception, whatever the outcome);\n* Age ≥18 years;\n* Viral infection studied known before pregnancy or diagnosed during pregnancy;\n* Signed, free, informed and written consent;\n* Be cared for in one of the maternity units taking part in the study\n\nNewborns\u002Fchildren:\n\n\\- Free, informed, written and signed consent of parental guardians.\n\nExclusion Criteria:\n\nPregnant women :\n\n* Planned delivery in a non-study center;\n* Planned absence that could hinder participation in the research;\n* Vulnerable population (minors, persons under guardianship or trusteeship, or persons deprived of their liberty by judicial or administrative decision);\n* Level of French oral comprehension insufficient according to the investigator for the research process understanding\n\nNewborns\u002Fchildren:\n\n* Refusal of parental authority to allow newborn\u002Fchild to participate in study\n* Follow-up of the child planned in a center not participating in the study\n* Scheduled absence of parents that could hinder the child's participation in the study;","FEMALE",{"count":82,"type":21},5160,"The VIROPREG study is a French prospective multicenter cohort study that aims to assess the impact of viral infections and antiviral treatments received during pregnancy on maternal and child health. The study focuses on both chronic viral infections: human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV)\\] and on arbovirus infections.\n\nThis study aims at investigating the following research questions:\n\n* What is the rate of mother-to-child transmission for each virus?\n* What are the effects of maternal infection on (i) pregnancy outcomes, (ii) the mother's physical and psychological health, and (iii) the fetus' health and development, with a focus on long-term psychomotor development in children born to women living with HIV?\n* What is the impact of antiretroviral and\u002For antiviral prophylactic and\u002For therapeutic treatments administered during pregnancy on maternal and fetal health? Mother-child pairs will be followed from pregnancy through delivery and from birth until the child reaches 7 years of age. Each mother-child pair will be enrolled into one of four cohort groups based on the maternal infection.\n\nHIV Cohort:\n\nPregnant women living with HIV who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6-8 weeks post-partum)\n* Participate in additional follow-up by phone call or videoconference at 4- and 7-years post-partum for research purposes\n* Complete questionnaires at inclusion, delivery, 4- and 7- years postpartum\n* In case of breastfeeding, receive follow-up care aligned with routine schedules for up to 2 years postpartum, including 2 additional visits specifically for research at 2- and 3- months postpartum.\n* In selected cases: provide blood, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes (pharmacological and virological analyses).\n\nChildren born to mothers living with HIV and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth until 2 years of age\n* Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.\n\nHBV Cohort:\n\nPregnant HBV-infected women who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6- 8 weeks post-partum)\n* Complete questionnaires at inclusion and delivery\n* Provide blood samples during follow-up visits for research purposes.\n\nChildren born to HBV-infected mothers and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth to 2 years of age\n* Participate in additional follow-up for research purposes at 3 months and 18-24 months of age.\n\nHCV Cohort:\n\nPregnant HCV-infected women who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6 - 8 weeks post-partum)\n* Complete questionnaires at inclusion and delivery\n* Provide blood samples during follow-up visits for research purposes.\n\nChildren born to HCV-infected mothers and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth until 2 years of age\n* Attend additional follow-up visits scheduled at 3 and 9 months of age for research purposes.\n\nArbovirus Cohort:\n\nPregnant women infected with arbovirus who participate in the research will:\n\n* Be followed according to the routine care schedule from enrollment to delivery\n* Participate in additional follow-up for research purposes at 4 years after delivery.\n* In case of breastfeeding, women will be monitored for research purposes at Day 7 and Day 30 postpartum\n* Complete questionnaires at inclusion, Day 7-10 from the inclusion, delivery and 4 years after delivery\n* Provide blood, amniotic fluid, placenta, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes.\n\nChildren born to mothers infected with arbovirus and who participate in the research will:\n\n* Be followed according to the routine care schedule from birth until 2 years of age.\n* Participate in additional follow-up for research purposes at inclusion, Day 7 and Day 30 after inclusion\n* Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.",[85,27,86,87,88],"HIV Infection","HDV Infection","HCV Infection","Arbovirus Infections",[90,91,92,93,94,95,96,97,98,99,100,101],"Pregnancy","HIV","HBV","HCV","Arbovirus","National health data system","Neurocognitive disorders","Quality of life","Pregnancy viral infections","Mother-to-child transmission","Social epidemiology","Hepatitis","2026-02-09",{"date":104,"type":32},"2026-02-17",{"date":106,"type":21},"2026-02",{"date":108,"type":21},"2039-12",{"name":110,"class":111},"ANRS, Emerging Infectious Diseases","OTHER_GOV",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":122,"studyType":50,"phases":4,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":71},"100603494","immune-dynamics-in-the-natural-history-of-chronic-hbv-infection-100603494","NCT07137247","Immune Dynamics in the Natural History of Chronic HBV Infection","Inclusion Criteria:\n\n* Aged 1-80 years, either male or female.\n* Patients diagnosed with chronic hepatitis B virus infection in accordance with the \"Guidelines for the Prevention and Treatment of Chronic Hepatitis B\" (2019 edition).\n* No antiviral treatment (including nucleoside analogs and interferons, etc.) within the past six months.\n\nExclusion Criteria:\n\n• Concurrent Infections and Liver Diseases: Exclusion of patients with concurrent HCV or HIV infection, alcoholic fatty liver disease, non-alcoholic fatty liver disease, autoimmune liver diseases.\n\n• Immune and Coagulation System Disorders: Exclusion of patients with immune system diseases such as hyperthyroidism, coagulation system disorders such as diabetes mellitus or idiopathic thrombocytopenic purpura.\n\n* Severe Underlying Diseases. Exclusion of patients with severe underlying diseases that affect the body's immune status.\n* Other Unsuitable Conditions:\n\nExclusion of patients whom the investigator deems to have other conditions that make them unsuitable for enrollment.","1 Year","80 Years",{"count":121,"type":21},5000,"3 Years","The purpose of this observational study is to follow up on chronic HBV-infected patients over a long period of time to understand the changes in the immune status as age increases and the natural history of chronic HBV infection progresses. The main questions it aims to answer are:\n\n* Does the natural history of chronic HBV infection progress with changes in HBV-specific immunity?\n* What is the role of age in the natural history of chronic HBV infection?\n\nPatients with chronic HBV infection who are untreated and aged 1-80 years will be followed up every six months. During each follow-up, HBV-related serological and virological indicators will be tested. Peripheral blood samples will also be collected to test HBV-specific immunity and the immune environment.",[125,27,126],"HBV (Hepatitis B Virus)","Chronic Hep B",[92,126,58],"2025-09-28",{"date":130,"type":32},"2025-09-30",{"date":132,"type":32},"2024-02-01",{"date":134,"type":21},"2041-12-01",{"name":69,"class":70},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":4},"100599718","clinical-trials-of-the-hepatitis-b-sandwich-combination-therapy-for-treating-patients-infected-with-hepatitis-b-virus-100599718","NCT07088133","Clinical Trials of the Hepatitis B Sandwich Combination Therapy for Treating Patients Infected With Hepatitis B Virus","Inclusion Criteria:\n\n1. Male or female subjects aged ≥18 weeks and ≤70 years, with an expected survival time of more than 12 months;\n2. HCC subjects who have undergone radical surgery or ablation therapy, and no residual tumor lesions in the liver (R0 resection) were found in the postoperative review, and the postoperative pathological specimens confirmed that they were primary liver cancer and had evidence of chronic hepatitis, no evidence of extrahepatic metastasis, and did not require postoperative adjuvant therapy for low- and medium-risk subjects;\n3. Barcelona Clinic Liver Cancer (BCLC) stage 0 or A; Child-Pugh liver function grade A during the screening period, ECOG score 0;\n4. No imaging evidence of invasion of the main portal vein branches; Clinically diagnosed with chronic hepatitis B (serum HBsAg positive ≥6 months);\n5. Understand and are willing to sign the informed consent form, and are willing to comply with all research procedures specified in this study;\n6. Females of childbearing age have negative blood pregnancy tests, and subjects of childbearing age (including male subjects) have no pregnancy plans in the next 3 months and voluntarily take effective contraceptive measures;\n7. Have received antiviral treatment with nucleoside (acid) analogs such as tenofovir alafenamide fumarate (TAF), tenofovir disoproxil fumarate (TDF) or entecavir (ETV) for at least one year, and have received stable treatment with nucleoside (acid) analogs for ≥2 months during the screening period, and agree to continue using them during the study. For subjects who have previously used non-first-line nucleoside (acid) analogs such as lamivudine\u002Fadefovir\u002Ftelbivudine, they agree to switch to first-line ETV\u002FTAF\u002FTDF\u002FTMF and continue to use;\n8. HBV DNA \\\u003C2000 copies\u002Fml or 200 IU\u002Fml at screening; HBsAg \\>10IU\u002Fml and \\\u003C3000 IU\u002Fml;\n9. With adequate organ and bone marrow function, laboratory test values meet the following requirements:\n\n   1. Routine blood test: absolute neutrophil count (ANC) ≥1.5×109 \u002FL; platelet count (PLT) ≥90×109 \u002FL; hemoglobin content (HGB) ≥90g\u002FL;\n   2. Liver function: serum albumin \\>35g\u002FL; serum total bilirubin (TBIL) ≤2.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤10.0×ULN; alkaline phosphatase (ALP) ≤2.5×ULN;\n   3. Coagulation function: international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN. If the subject is taking anticoagulant therapy such as warfarin or heparin, it is necessary to ensure that the protocol requirements are met when the drug is stopped or not used;\n   4. Urinalysis: urine protein negative or 24-hour urine protein quantitative ≤ ULN. Screening urine protein 1+ can be further confirmed by rechecking urine routine, and 24-hour urine protein quantitative test can be performed if necessary;\n   5. Electrolytes are normal or normal after treatment or are judged by the researcher to be abnormal and have no clinical significance;\n   6. Creatinine clearance (Ccr) \\>50 mL\u002F(min·1.73m2)\n\nExclusion Criteria:\n\n1. Liver transplant or liver transplant candidate; previous or current diagnosis of psychiatric illness or major depression;\n2. Other malignancies, except for carcinoma in situ of the cervix and\u002For non-melanoma skin cancer and superficial bladder tumors (Ta \\[non-invasive tumor\\], Tis \\[breast cancer in situ\\], and T1 \\[tumor invading the lamina propria\\]). Any cancer that has been effectively treated for more than 3 years before participating in the study is allowed;\n3. Those with clinical symptoms of brain metastases, or other evidence that the subjects' brain metastases have not been controlled, and\u002For meningeal metastases, are judged by the researchers to be unsuitable for inclusion;\n4. Past or current ascites, esophageal or gastric varicose bleeding caused by portal hypertension, hepatorenal syndrome, hepatic encephalopathy or liver failure, suspected cirrhosis or compensated cirrhosis, etc.;\n5. Liver diseases caused by other reasons, including chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis, hepatolenticular degeneration and hemochromatosis;\n6. Interferon or pegylated interferon treatment or other strong immunomodulators such as adrenocortical hormone, thymosin a1, thymosin 5 peptide, etc. were used within 12 weeks before the first use of the study drug, or interferon or pegylated interferon treatment or other strong immunomodulators such as adrenocortical hormone, thymosin a1, thymosin 5 peptide, etc. are planned to be used during the trial;\n7. Immunosuppressants used within 6 months before the first use of the study drug; corticosteroids used for 1 week or more within 6 months before the first use of the study drug (except topical or inhaled corticosteroids);\n8. Positive hepatitis C virus (HCV), hepatitis D virus (HDV), Treponema pallidum (TP) antibodies or human immunodeficiency virus (HIV) antibodies;\n9. A history of clinically significant cardiovascular disease, including but not limited to: myocardial infarction, uncontrolled angina pectoris, viral myocarditis, stroke or other grade 3 or above cardiovascular and cerebrovascular events within 6 months before the first administration of this study drug; any supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention, left ventricular ejection fraction (LVEF) \\\u003C50%, congestive heart failure of New York Heart Association (NYHA) heart function class III or IV, uncontrolled hypertension \\[systolic blood pressure (SBP) ≥160mmHg and\u002For diastolic blood pressure (DBP) ≥100mmHg after standard treatment or history of hypertensive crisis or hypertensive encephalopathy\\];\n10. Any life-threatening bleeding event in the past 3 months, including the need for transfusion, surgery or local treatment, and continuous drug treatment;\n11. Those who are known or may be allergic to HT-102 or FD-001 and its excipients; those who have a known history of allergy to hepatitis B vaccination;\n12. Participated in another clinical trial of a study drug or biological agent within 30 days or 5 half-lives before the first use of the study drug;\n13. Pregnant or breastfeeding women; those who the investigator believes are not suitable for participation in this trial due to other reasons;\n14. Active autoimmune diseases Patients with active autoimmune diseases or known history of autoimmune diseases who require systemic hormone or immunosuppressant treatment, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, Wegener's granulomatosis, Sjögren's syndrome, inflammatory bowel disease, multiple sclerosis, myasthenia gravis, myositis, autoimmune hepatitis, vasculitis, immune thrombocytopenic purpura, autoimmune hemolytic anemia and glomerulonephritis. Excluded: Subjects with endocrine diseases that can be controlled by HRT (such as hypothyroidism, type 1 diabetes, etc.)","70 Years",{"count":144,"type":21},12,[146],"NA","* Primary objective: The main objective of this study is to assess the efficacy and safety of a sandwich combination therapy in patients who were infected with HBV or have undergone surgery for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). The primary efficacy endpoints are HBsAg seroconversion rate (HBsAg disappearance and HBsAb appearance), and HCC recurrence rate at week 49. Secondary Objective: To evaluate the safety of the HBV sandwich combination therapy through various safety indicators. Safety Indicators as follows: 1) Vital Signs: Monitoring systolic and diastolic blood pressure, pulse, respiration, and body temperature; 2) Physical Examination: Comprehensive physical assessments during the study; 3) 12-lead Electrocardiogram: Conducted to monitor cardiac health; 4) Clinical Laboratory Tests: Including blood routine, urine routine, blood biochemistry (focusing on liver and kidney function), coagulation function; 5) Injection Site Reactions: Monitoring for any local adverse effects from injections; 6) Adverse Events (AEs) and Serious Adverse Events (SAEs): Documentation of any AEs or SAEs occurring during treatment.\n* Study Design: This study comprises three distinct stages:\n\n  1. Screening Period (Weeks -4 to -1): 1) Informed consent will be obtained from participants; 2) Collect baseline data and perform various assessments which include: a) 12-lead ECG; b) Infectious disease screening; c) Blood biochemistry, routine blood, urine routine, coagulation function; d) Blood pregnancy test (for female subjects); e) Hepatitis B virus and serology examination; f) Antinuclear antibody testing; g) Imaging examinations.\n  2. Treatment Period (Weeks 1 to 25): 1) Patients will receive ongoing nucleoside analogue treatment (NAs) throughout this stage; 2) Administer subcutaneous injections of the HBV monoclonal antibody HT-102 weekly for a total of 4 weeks (300 mg each time); 3) After treatment with HT-102, HBV serological and virological assessments will occur; 4) If serum HBsAg is below 10 IU\u002FmL, proceed with therapeutic hepatitis B vaccine FD-001 (60 µg each time) every 4 weeks for a total of 6 doses; 5) If HBsAg is not below 10 IU\u002FmL post HT-102, participants will enter the follow-up period directly.\n  3. Follow-up Phase (Weeks 25 to 49): 1) Continue with original nucleoside analogue treatment for HBV; 2) Conduct follow-up visits every 12 weeks; 3) Each visit will involve recording vital signs, conducting physical examinations, ECG, laboratory tests (as noted in safety indicators), and testing for HBV and immunological parameters.\n* End of Study:\n\nThe study concludes once the follow-up of the last enrolled subject is completed, analyzing the collected data to evaluate efficacy and safety endpoints.\n\n\\- Note: Careful monitoring and adherence to protocols will be maintained to ensure participant safety and integrity of study data.",[27,149],"HCC - Hepatocellular Carcinoma","2025-07-18",{"date":152,"type":32},"2025-07-28",{"date":154,"type":21},"2025-08-01",{"date":156,"type":21},"2026-08-01",{"name":158,"class":70},"Shanghai Zhongshan Hospital",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":80,"minAge":17,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":4},"100597120","hbv-universal-vs-point-of-care-based-antiviral-treatment-to-prevent-mother-to-child-transmission-100597120","NCT07054359","\"HBV unIversal vs Point-Of-Care-based Antiviral treatMent to Prevent Mother-to-child Transmission\"","HIPOCAMP","Inclusion Criteria:\n\n1. ≥18 years old, or ≥ the legal age of majority as defined by each country, on the day of inclusion.\n2. Pregnancy.\n3. Intention to attend antenatal care visits in the Primary Health Center or the Rural Hospital\n4. Living in an area covered by the Primary Health Center or the Rural Hospital on the start date of the trial\n5. Positive HBsAg identified during the screening phase of the study\n6. Free, informed, and written consent, signed by the person and the investigator at the latest on the day of inclusion and before any examination carried out as part of the study.\n\nExclusion Criteria:\n\n1. HIV co-infection.\n2. HBV treatment ongoing on the day of inclusion.\n3. Having at least one of the following criteria indicatives of the third trimester of pregnancy:\n\n   * Gestational Age-Based Exclusion:\n\n   The reported gestational age is ≥28 weeks, based on the last menstrual period (LMP) if known.\n   * Ultrasound-Based Exclusion:\n\n   Fetal biometry (e.g., head circumference, femur length) on ultrasound suggests a gestational age of ≥28 weeks.\n   * Fundal Height-Based Exclusion:\n\n   Symphysis-fundal height (SFH) measurement of ≥ 28 cm which corresponds to approximately 28 weeks of gestation.\n4. Severe gravid disease at inclusion, which poses a life-threatening risk to the mother and\u002For child\n5. Any concomitant medical condition that, according to the clinical site investigator, would contraindicate participation in the study.\n6. Concurrent participation in any other study (unless approved in writing by the Global Principal Investigators).","50 Years",{"count":168,"type":21},3200,[146],"To achieve global elimination of hepatitis B virus (HBV), it is crucial to eliminate HBV mother-to-child transmission (MTCT) by ensuring high coverage of birth dose vaccine and expanding the adoption of peripartum antiviral prophylaxis (PAP) by tenofovir. Current international guidelines require hepatitis B surface antigen (HBsAg)-positive pregnant women to undergo viral load (VL) quantification to identify those at high risk (VL ≥200,000 IU\u002FmL) who should receive PAP. However, VL testing remains inaccessible in many low- and middle-income countries (LMICs), particularly in rural areas. Consequently, in the forthcoming guidelines, the WHO is going to issue a conditional recommendation for administering PAP to all HBsAg-positive women lacking access to VL testing. Although this universal strategy may appear promising for simplifying the diagnostic process, it may result in overtreating the majority of HBsAg-positive pregnant women, estimated at 85% in Africa and 70% in Asia, for whom birth dose vaccine is likely sufficient. Moreover, the real-world applicability of this strategy in LMICs has never been formally tested.\n\nAs an innovative alternative, the adoption of a rapid point-of-care test for hepatitis B core-related antigen (HBcrAg-RDT) is proposed to identify women eligible for PAP.This test requires only a drop of capillary blood, eliminating the need for electricity or centrifugation, and can provide a reliable result within 45 minutes. Compared to the universal strategy, HBcrAg-RDT strategy is expected to be less expensive and could prevent unnecessary tenofovir exposure for both women and their fetuses. Our aim is to establish the non-inferiority of the HBcrAg-RDT strategy, in comparison to the universal strategy, in terms of effectiveness, defined as the reduction in maternal VL at the time of childbirth, a main driver of the MTCT risk. This will be approached through a multidisciplinary framework integrating health economics, implementation science, and health policy analysis.",[27,90],[90,173,174,175,176],"Mother to child transmission","Public health","Hepatitis B","Cluster-randomized controlled trial","2025-06-27",{"date":179,"type":32},"2025-07-08",{"date":181,"type":21},"2025-11",{"date":183,"type":21},"2028-01",{"name":110,"class":111}]