[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatitis-b\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatitis-b":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,35,0,25,[9,44,75,97,119,147,179,205,231,258,288,310,339,372,401,433,473,497,524,556,581,603,628,649,677],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":4,"leadSponsor":40,"locationsCount":43},"100054882","evaluation-of-patients-with-liver-disease-100054882",false,"NCT00001971","Evaluation of Patients With Liver Disease","* INCLUSION CRITERIA:\n\nAffected Subjects\n\nIn order to be eligible to participate in this study, an affected participant must meet all of the following criteria:\n\n1. \\>=2 years of age.\n2. Meets one of the following:\n\n   1. Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), OR\n   2. At risk for acute or chronic liver disease\n\nHealthy Volunteers\n\nIn order to be eligible to participate in this study, a healthy volunteer must meet all of the following criteria:\n\n1. \\>= 18 years of age.\n2. In good general health as evidenced by medical history\n\nEXCLUSION CRITERIA:\n\nAffected Participants\n\nAn affected participant who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. History of significant medical illnesses that might interfere with prolonged follow up evaluation\n\nHealthy Volunteers\n\nA healthy volunteer who meets any of the following criteria will be excluded from participation in this study:\n\n1. Any chronic medical condition, including (but not limited to) heart, kidney, or lung diseases\n2. Taking any regular medications or supplements (with the exception of regular multivitamins and\u002For oral contraceptives)\n3. Average alcohol consumption \\> 1 drink\u002Fday in past 6 months, per self-report\n4. History of liver disease (with the exception of neonatal jaundice)\n5. History of severe illness, infection or major surgery in the past year\n6. History of cancer (with the exception of basal cell carcinoma resected \\> 1 year prior to enrollment)\n7. BMI \\\u003C 18 or BMI \\>25\n8. Hemoglobin \\\u003C 11 (women) or hemoglobin \\\u003C 12 (men)\n9. ALT \\>35 (men) or ALT \\>25 (women)\n10. Alkaline Phosphatase \\>= 150\n11. Bilirubin \\>2 g\u002FdL\n12. HIV positive, Anti-HCV positive, HBsAg positive or Anti-HBc positive\n13. Pregnancy\n14. Inability to provide informed consent",true,"ALL","2 Years","100 Years",{"count":21,"type":22},8050,"ESTIMATED","OBSERVATIONAL","The proposed study aims to evaluate, investigate, and follow-up patients suffering from acute and chronic liver disease. The study will focus on understanding diseases affecting the liver.\n\nPatients participating in the study will first undergo a routine check-up as an outpatient. They will be asked to provide blood and urine samples for laboratory testing and will undergo an ultrasound of the liver. Ultrasound examinations use sound waves to determine the size and texture of the liver. After the initial visit subjects will be requested to follow-up once a year at the outpatient department for a similar check-up.\n\nAdditional tests may be requested throughout the study to provide information for other research studies and individual consent will be requested. These tests may include liver biopsies, skin biopsies, and \u002F or specialized blood, plasma, and lymphocyte examinations.\n\nSubjects that qualify for medications presently being studied may be offered the opportunity to benefit from experimental therapy.",[26,27,28,29],"Hepatitis D","Hepatitis C","Hepatitis B","Liver Disease",[28,27,26,31,32,29],"Chronic Hepatitis","Natural History","RECRUITING","2026-06-27",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":37},"1992-05-27",{"name":41,"class":42},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":43},"100580198","non-interventional-study-to-assess-the-number-of-people-with-untreatedunknown-hbv--hdv-and-hcv-in-south-east-austria-100580198","NCT06834178","Non-interventional Study to Assess the Number of People With Untreated\u002FUnknown HBV + HDV and HCV in South-East Austria","Hepatitis Elimination And Liver Care in South-East Austria (HEAL-S)","HEAL-S","Inclusion Criteria:\n\n* The target population for the HCV cohort consists of individuals with detectable plasma HCV RNA at the latest observation.\n* The target population for the HBV cohort consists of individuals with detectable plasma HBV RNA at any time and no recorded HDV testing or a positive HDV serology.\n\nExclusion Criteria:\n\n* No valid SVRN (german: Sozialversicherungsnummer, english: Social insurance number)\n* No contact details available\n* Documented Sustained Virological Response (HCV cohort)\n* Documented assessment of HDV status (HBV cohort)",{"count":53,"type":22},100,"The HEAL-S study is a non-interventional study with retrospective data analysis. It consists of two parts. First a retrospective analysis based on nucleic acid testing (NAT) results will be performed. Two cohorts (HCV) and (HBV) will be established. Patients falling into one (or both) of the two cohorts will be invited to a prospective linkage-to-care study. In this part, patients are invited to the clinic, where the possibility of hepatitis treatment will be discussed.",[56,57,58,59,60,28],"HBV","HCV","HDV","Coinfection","Hepatitis B Coinfection",[56,57,58,62,63,28,27,64],"Hepatitis B and D coinfection","untreated hepatitis","Hepatitis treatment","2026-06-17",{"date":67,"type":37},"2026-06-18",{"date":69,"type":37},"2025-05-01",{"date":71,"type":22},"2026-10",{"name":73,"class":74},"Vanessa Stadlbauer-Koellner, MD","OTHER",{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100349104","creation-of-a-cohort-for-the-quantitation-and-characterization-of-circulating-viral-rnas-as-a-new-biomarker-of-hepatitis-b-functional-cure-100349104","NCT03825458","Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.","CirB-RNA","Inclusion Criteria:\n\n* Adults patients and minor children over 6 years of age (in Lyon) with acute or chronic hepatitis B or presenting with HBsAg loss (with\u002Fwithout HBs seroconversion). (Co-infected patients with HDV and\u002For HCV and\u002For HIV are eligible)\n* Patients requiring blood sampling for medical care at the time of the medical appointment.\n* Informed patients who do not refuse to participate.\n* Persons not affiliated to a social security scheme and persons receiving medical assistance from the state may be asked to participate in the study\n\nExclusion Criteria:\n\n* Patients participating at the time of the inclusion to an interventional trial evaluating a drug likely to interfere with this study.\n* Persons deprived of their liberty by a judicial or administrative decision\n* Adults who are subject to a legal protection measure\n* Children less than 6 years old (in Lyon)","18 Years",{"count":84,"type":22},3500,"The \" CirB-RNA \" cohort aims to create a biological collection associated with clinical and biological data from patients with hepatitis B infection. This project is part of a much larger program that aims to characterize and quantify circulating viral RNAs as a possible new biomarker of hepatitis B functional cure.",[28],"2026-05-20",{"date":89,"type":37},"2026-05-22",{"date":91,"type":37},"2019-02-25",{"date":93,"type":22},"2029-06-25",{"name":95,"class":74},"Hospices Civils de Lyon",6,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"100432707","real-world-assessment-of-people-living-with-chronic-hepatitis-b-in-australia-100432707","NCT04914611","Real World Assessment of People Living With Chronic Hepatitis B in Australia","REACH-B","Inclusion Criteria:\n\n1. All individuals diagnosed with chronic hepatitis B in the participating study sites are eligible to be included (both newly diagnosed cases and those diagnosed in the past).\n2. 16 years of age or older.\n3. Attended the health service for HBV care within the prior 12 months from study commencement (retrospective recruitment) OR Attending the health service for HBV care from study commencement (prospective recruitment)\n\nExclusion Criteria:\n\n1\\. Nil",{"count":105,"type":22},10000,"The REACH-B study establishes an observational cohort study of people living with chronic hepatitis B from a national network, including a diverse range of services, to characterise and monitor hepatitis B linkage to care and treatment requirements amongst this population.",[28],"2026-05-18",{"date":110,"type":37},"2026-05-19",{"date":112,"type":37},"2022-02-17",{"date":114,"type":22},"2030-07-31",{"name":116,"class":117},"Kirby Institute","OTHER_GOV",19,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":17,"minAge":126,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":43},"100357388","phase-4-tenofovir-alafenamide-versus-entecavir-for-the-treatment-of-chronic-hepatitis-b-100357388","NCT03933384","Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B","Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: An Open Label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patients more than 20 years old\n2. Chronic hepatitis B patients\n3. Patients who were indicated for hepatitis B virus antiviral therapy\n\nExclusion Criteria:\n\n1. Decompensated liver disease (Child-Pugh B \\&C)\n2. End stage renal disease (eGRF \\\u003C 15 ml\u002Fmin\u002F1.73m2)\n3. Prior use of nucleot(s)ide analogues for chronic hepatitis B\n4. Prior use of interferon for chronic hepatitis B within six months\n5. Known history of human immunodeficiency virus or hepatitis C virus co-infection\n6. Concurrent other uncontrolled malignancy\n7. Women in pregnancy or lactation\n8. Cannot conform to the study protocol of this study","20 Years",{"count":128,"type":22},140,"INTERVENTIONAL",[131],"PHASE4","To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.",[28,134],"Viral Hepatitis",[28,134,136,137],"Tenofovir alafenamide","Entecavir","2026-05-11",{"date":140,"type":37},"2026-05-14",{"date":142,"type":37},"2019-08-19",{"date":144,"type":22},"2030-12-31",{"name":146,"class":74},"Taichung Veterans General Hospital",{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100640344","hep-mec-cohort-in-zambia-100640344","NCT07589985","Hep Mec Cohort in Zambia","Hep Mec","Inclusion Criteria:\n\nMust meet the inclusion criteria for one of 5 groups, as follows:\n\n* Group 1 (rx-naive chronic hbv mono): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped \\>1 year ago).\n* Group 2 (acute hbv mono): 18+ years old, HBsAg-positive, HIV-negative, acute\u002Fsubacute onset of hepatitis signs and symptoms and ALT \\>10 times upper limit of normal\n* Group 3 (rx-naive hbv\u002Fhiv coinfection): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped \\>1 year ago).\n* Group 4 (rx-experienced coinfection with hbv persistence): 18+ years old, history of chronic HBV infection based on two tests 6 months apart, HIV-positive, at least 4 years of tenofovir-based antiviral therapy, currently HBsAg-positive\n* Group 5 (hbsag loss): 18+ years old, HIV-positive or negative, history of chronic HBV infection based on two tests 6 months apart, Currently HBsAg-negative confirmed by sensitive assay\n\nExclusion Criteria:\n\n* Hepatitis C coinfection (antibody-positive and RNA-positive), current or recent (past 6 weeks) pregnancy, decompensated cirrhosis on physical examination, unlikely to remain in Lusaka for study duration",{"count":155,"type":22},390,"Observational cohort of adults with acute and chronic hepatitis B infection in Zambia, with and without HIV coinfection. Participants join the study at the time of diagnosis and before or at the time when they are starting antiviral treatments and then they are followed up over multiple years to assess changes to their liver and evolution of HBV (and HIV if applicable) infection. All treatments for HBV and HIV are standard per local Ministry of Health guidelines.",[28,158],"HIV",[160,161,162,163,164,165,166,167,168],"HBV\u002FHIV coinfection","HBV immunology","Liver sampling","Africa","Tenofovir","T cell immunology","Omics analysis","Acute HBV infection","Liver immunology","2026-05-09",{"date":171,"type":37},"2026-05-15",{"date":173,"type":37},"2020-09-28",{"date":175,"type":22},"2030-08-31",{"name":177,"class":74},"University of Alabama at Birmingham",3,{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":129,"phases":189,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":43},"100349178","phase-1-huc-mesenchymal-stem-cells-19isclife-lc-in-the-treatment-of-decompensated-hepatitis-b-cirrhosishepatitis-b-cirrhosis-100349178","NCT03826433","hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis","Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis","Inclusion Criteria:\n\n* Age 18-60 years old, gender not limited, body mass index (BMI) between 19-25 kg\u002Fm2, including boundary value;\n* The diagnosis of hepatitis B cirrhosis was in line with the 2015 American society of hepatology (AASLD) guidelines for the treatment of chronic hepatitis B, and the liver function grade was child-pugh B or child-pugh C, with a score range of 7-12 points, and Model for End-Stage Liver Disease score≤21 points.\n* Have not received stem cell therapy in the recent 6 months;\n* Subjects will be able to sign the informed consent in accordance with the study procedures and instructions.\n\nExclusion Criteria:\n\n* Insufficiency of vital organs, such as heart, kidney and lung;\n* End-stage cirrhosis with severe complications, including but not limited to: hepatic encephalopathy, gastrointestinal bleeding,Severe bleeding tendency, massive ascites, etc.\n* Concomitant peritonitis, pneumonia, or other types of infection not under control;\n* Have a history of severe allergic reaction or allergy to two or more kinds of food or medicine;\n* Positive serum HIV antibody and syphilis antibody;\n* Alpha fetoprotein\\>400ng\u002FmL with primary liver cancer or without imaging evidence;\n* Chronic liver disease and cirrhosis are caused by non-chronic hepatitis B virus infection, or other factors except chronic hepatitis B virus infection ;\n* Patients with severe mental illness and cognitive impairment;","60 Years",{"count":188,"type":22},20,[190],"PHASE1","1. Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.\n2. Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat.\n3. Explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.",[28],[194],"Hepatitis B Cirrhosis, mesenchymal stem cell","2026-04-22",{"date":197,"type":37},"2026-04-23",{"date":199,"type":37},"2018-10-01",{"date":201,"type":22},"2027-12-31",{"name":203,"class":204},"Sclnow Biotechnology Co., Ltd.","INDUSTRY",{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":129,"phases":214,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":230},"100469255","screening-for-hepatitis-b-hepatitis-c-and-aids-viruses-using-dried-blood-spot-100469255","NCT05390424","Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot","BUVARD76_27","Inclusion Criteria:\n\n* Former or active intravenous and\u002For nasal drug user\n* Person on opiate substitution therapy\n\nExclusion Criteria:\n\n* Person with known active viral infection(s)",{"count":213,"type":22},500,[215],"NA","The aim of the study is to screen for hepatitis B, hepatitis C and AIDS viruses using a Dried Blood Spot in drug users",[28,27,218],"AIDS",[220],"Dried Blood Spot","2026-02-12",{"date":223,"type":37},"2026-02-17",{"date":225,"type":37},"2022-12-02",{"date":227,"type":22},"2027-01",{"name":229,"class":74},"University Hospital, Rouen",11,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":129,"phases":241,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":257},"100505095","phase-1-hepb-mab19-in-individuals-with-chronic-hepatitis-b-infection-100505095","NCT05856890","HepB mAb19 in Individuals With Chronic Hepatitis B Infection","A Phase 1, Placebo-controlled, Dose-escalation Study of the Safety, Pharmacokinetics, and Antiviral Activity of a Potent Neutralizing Monoclonal Antibody in Individuals With Chronic Hepatitis B Infection","Inclusion Criteria:\n\n* Age 18 to 70;\n* HBV infection confirmed by positive HBsAg for \\>\u002F= 6 months;\n* On HBV-active nucleos(t)ide therapy for \\>\u002F= 6 months without change in NRTI in the previous 3 months;\n* The following laboratory values within 49 days from study entry (day 0):\n* HBV DNA below lower limit of quantification;\n* HBsAg \\> 10 IU\u002FmL;\n* HBs antibody negative;\n* Ability and willingness to provide informed consent;\n* For participants who can become pregnant (i.e., participants who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and\u002For bilateral oophorectomy or bilateral salpingectomy), negative serum or urine pregnancy test at screening and on day 0 (study entry).\n* Participants who can become pregnant must agree to use two methods of contraception.\n* Partner sterilization with documentation of azoospermia prior to the participant's entry into the study, and this partner is the sole partner for that participant. The documentation of partner sterility can come from the site personnel's review of medical records or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents.\n* Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms from 10 days prior to study entry and during study follow up to avoid impregnating a partner who can get pregnant.\n\nExclusion Criteria:\n\n\\- Clinical symptoms, imaging studies or liver histology suggestive of advanced fibrosis (exclude fibrosis grade 3 and 4 by FibroScan (Fibroscan®\\\u003C 9 kpa) within 12 months from entry or done at the pre-infusion visit.\n\nNote: If FibroScan results from within 12 months are not available, imaging will be performed at the pre-infusion visit.\n\n* Presence of a LI-RADS4 or 5 liver lesion on imaging within 12 months from entry or done at pre-infusion visit, if prior results not available.\n* Alpha fetoprotein \\> 20 ng\u002Fml Note: AFP above normal but \\\u003C 20 is acceptable for entry if earlier AFP levels (older than 6 months) are within normal range and imaging is negative in last 3 months).\n* HIV-1, HCV or hepatitis delta virus infection within 12 months from entry or done at screen, if prior results not available.\n* History of hematopoietic stem cell transplant or solid organ transplant;\n* Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, monoclonal antibody or vaccine, or multiple drug allergies (non-active hay fever is acceptable);\n* History of cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death);\n* History or presence of clinically significant ECG abnormalities based on the average of the triplicate ECG recordings (e.g., QT corrected for heart rate using the Fridericia's correction factor \\[QTcF\\] \\> 450 ms for males and QTcF \\> 470 ms for females);\n* History of systemic corticosteroids, immunosuppressive anti-cancer, systemic interferons or interleukins within the last 6 months;\n* History of chronic liver disease from another cause, immune complex disease, or autoimmune diseases that in the opinion of the investigator would preclude participation.\n* Any significant acute infection (e.g. influenza, COVID-19) or any other clinically significant illness within 2 weeks prior to Day 0.\n* Laboratory abnormalities in the parameters listed below:\n* Absolute neutrophil count \\\u003C 1,000 \u002Fmm3\n* Hemoglobin \\\u003C 10 gm\u002FdL\n* Platelet count \\\u003C 150,000 \u002Fmm3\n* ALT \\> 2.0 x ULN\n* AST \\> 2.0 x ULN\n* Total bilirubin \\> 1.5 ULN (except individuals with known Gilbert's)\n* Albumin \\\u003C 3.5 gm\u002FdL\n* Calculated creatinine clearance \\\u003C 70 mL\u002Fmin (using the Cockcroft Gault formula).\n* INR \\>\u002F= 1.2\n* Pregnancy or lactation;\n* Any vaccination within 14 days prior to IP administration;\n* Receipt of anti-HBV mAb therapy of any kind in the past (including HBIG);\n* Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.","70 Years",{"count":240,"type":22},37,[190],"This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB mAb19, which targets the S-protein in individuals with chronic hepatitis B (CHB) on nucleos(t)ide analog therapy (NRTI).",[244,28],"Hepatitis b Virus",[246,56,247],"monoclonal antibody","HepB mAb19","2026-01-29",{"date":250,"type":37},"2026-02-02",{"date":252,"type":37},"2023-08-07",{"date":254,"type":22},"2028-03-30",{"name":256,"class":74},"Rockefeller University",2,{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":16,"sex":17,"minAge":265,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":129,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":278,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":4},"100576525","phase-4-managing-hepatitis-b-hep-b-and-human-papilloma-virus-hpv-related-cancers-and-mental-health-100576525","NCT06786429","Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers and Mental Health.","Managing Hepatitis B (Hep. B) and Human Papilloma Virus (HPV) Related Cancers Among Women of Childbearing Age, and Young Adults in Zimbabwe in the Context of Mental Health: a Multimodal, Multifaceted Approach.","Inclusion Criteria:\n\n* For the High school students' group:\n\nAll students aged 13 years and older, enrolled at the selected Mtshabezi and Matopo High Schools in the Gwanda and Matobo Rural Districts during the five-year period of the project are eligible to participate in the study.\n\nAbility to understand and respond to questions on the Youth Risk Behavior Scree questionnaire and PHQ-9 scale.\n\nRelevant history of HPV vaccine administration. Ability to obtain parental\u002Fguardian consent for participation.\n\n\\- For the women group: All women and young female adults thirteen to forty-five years old and requesting health services for prenatal, post-partum, family planning and other care during the five-year project period are eligible to participate.\n\nMust not have received Hep B and HPV vaccine in the past and have no known contraindications to either of these two vaccines.\n\nAre able to understand and respond to the PHQ-9 and Edinburgh Postnatal Depression scales.\n\nMust have a valid consent for participation in the study.\n\nExclusion Criteria:\n\n* males who are not enrolled in these participating High Schools.\n* children below the age of thirteen who are not enrolled in high schools and are not seeking prenatal, post-partum and family planning services at these selected health facilities during the project period.\n* Any eligible potential participant without a valid consent.\n* Any potential participant who is excluded by a doctor or midwife for a known contraindicating medical condition that can lead to potential harm to the participant or staff.\n\nAny potential participant who is unable to understand and respond to the questions being asked.\n\nParticipants with proof of prior vaccination will be excluded from this part of the study.","13 Years","45 Years",{"count":268,"type":22},1800,[131],"Aim: The main goal of this observational study is to determine the prevalence of Human Papilloma Virus(HPV) infection, and Hepatitis B (Hep B) immunity amongst women of childbearing age 13 to 45 years) attending clinics at Mtshabezi Mission and Matobo clinic respectively; and assess behavioral risk factors of high school students at these catchment areas that can put them at risk for developing cancer of the cervix and liver.\n\nQuestion: Can screening for cancer, and vaccination against Hep B and HPV, and cognitive behavior intervention help in preventing related cancers amongst these groups of participants.",[28,272,273,274,275,276,277],"Human Papilloma Virus","Gall Stones (& [Calculus - Gall Bladder])","Mental Health Issue","Cancer Liver","Cancer of Cervix","Depression, Anxiety","NOT_YET_RECRUITING","2026-01-17",{"date":281,"type":37},"2026-01-21",{"date":283,"type":22},"2026-08-30",{"date":285,"type":22},"2031-12-30",{"name":287,"class":74},"Eunice Dube",{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":129,"phases":297,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":278,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":4},"100612410","taf-monotherapy-versus-etv-combined-with-taf-on-the-efficacy-and-prognosis-of-immunotherapy-for-hepatitis-b-related-hepatocellular-carcinoma-100612410","NCT07253220","TAF Monotherapy Versus ETV Combined With TAF on the Efficacy and Prognosis of Immunotherapy for Hepatitis B-Related Hepatocellular Carcinoma","Prospective, Randomized, Controlled Clinical Study Comparing TAF Monotherapy Versus ETV Combined With TAF on the Efficacy and Prognosis of Immunotherapy for Hepatitis B-Related Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18 years, positive HBsAg for ≥ 6 months, and HBV DNA ≥ 2,000 IU\u002FmL within 2 weeks before enrollment;\n\n  * Histologically or clinically confirmed unresectable or metastatic hepatocellular carcinoma, Child-Pugh class A or B, ECOG performance status 0-1, and scheduled to receive systemic immunotherapy in the Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University;\n\n    * At least one measurable lesion that has either not undergone local therapy or has progressed after local therapy, as defined by modified RECIST (mRECIST); ④ Estimated life expectancy ≥ 12 weeks; ⑤ Signed informed consent form for study participation\n\nExclusion Criteria:\n\n* Co-infection with HCV or HIV; ② History of organ transplantation; ③ Presence of cardiac or renal insufficiency, or active autoimmune disease that constitutes a contraindication to immunotherapy.",{"count":296,"type":22},120,[215],"Study Objective: To compare the efficacy and prognosis of systemic cancer therapy between TAF monotherapy and ETV plus TAF combination therapy in patients with unresectable, advanced hepatitis-B-related hepatocellular carcinoma (HBV-HCC).\n\nStudy Design: Prospective, interventional cohort study. Participants: Patients with histologically or radiologically confirmed unresectable, advanced HBV-HCC who are scheduled to receive immune-based systemic therapy at The Third Affiliated Hospital of Sun Yat-sen University. Detailed inclusion\u002Fexclusion criteria are provided below.\n\nIntervention: Enrolled participants will be assigned to receive either TAF monotherapy or ETV combined with TAF for HBV suppression.\n\nPrimary Outcome: Overall survival (OS) at 24 months after initiation of systemic therapy, compared between the two HBV-treatment strategies.\n\nSecondary Outcomes: Decline in HBV DNA and HBsAg levels at 1, 3, 12 and 24 months.\n\nSample Size: 120 HCC patients (60 per arm). Statistical Analysis: All analyses will be performed with SPSS. Continuous variables will be tested for normality (Shapiro-Wilk). Normally distributed data are presented as mean ± SD; non-normally distributed data as median (IQR). Twenty-four-month OS will be estimated by Kaplan-Meier curves and compared with a Cox proportional-hazards model adjusted for age, BCLC stage, AFP level, and ICI regimen. PFS will be compared using the log-rank test; ORR and HBV DNA undetectable rate will be compared with χ² tests. Inverse-probability-of-treatment weighting (IPTW) will address selection bias, and multiple imputation will handle missing data.",[28,300],"Hepatocellular Carcinoma (HCC)","2025-11-26",{"date":303,"type":37},"2025-11-28",{"date":305,"type":22},"2025-12-01",{"date":307,"type":22},"2028-09-30",{"name":309,"class":74},"Sun Yat-sen University",{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":317,"enrollmentInfo":318,"targetDuration":4,"studyType":129,"phases":320,"briefSummary":321,"conditions":322,"keywords":326,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":338},"100522562","phase-4-national-liver-cancer-screening-trial-100522562","NCT06084234","National Liver Cancer Screening Trial","TRACER","Inclusion Criteria:\n\nPatient must meet all of the following inclusion criteria:\n\n1. Adult patients ages 18-85 with cirrhosis from any etiology or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months of enrollment\n2. Patient is eligible for HCC surveillance according to treating physician or by the site investigator\n3. Able to provide informed consent\n4. Life expectancy \\>6 months (after consent) as determined by the treating provider or site investigator\n\nExclusion Criteria:\n\nPatient will be excluded for any of the following exclusion criteria:\n\n1. Child Pugh C cirrhosis\n2. History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma\n3. History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic CT\u002FMRI demonstrating benign nature)\n4. AFP \\>20 ng\u002FmL within 6 months prior to consent, in the absence of a contrast-enhanced CT or MRI within 6 months of AFP (before or after) level demonstrating lack of suspicious liver lesions\n5. Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent\n6. History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI within 6 months prior to consent\n7. Presence of another active cancer besides non-melanomatous skin cancer or indolent cancer under active surveillance (e.g., prostate cancer or renal cell carcinoma) within the 2 years prior to consent\n8. Patient's provider is planning to use MRI- or CT- based surveillance moving forward\n9. History of a transjugular intrahepatic portosystemic shunt (TIPS)\n10. History of Fontan associated liver disease or cardiac cirrhosis\n11. History of solid organ transplantation\n12. Actively listed for liver transplantation\n13. Diagnosis of alcohol-associated hepatitis within 3 months prior to consent\n14. Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis)\n15. In patients with primary sclerosing cholangitis (PSC): Current active cholangitis within 90 days prior to consent\n16. Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples)\n17. In patients living with HIV: CD4+ T cell count less than 100 cells\u002Fmm3 within 60 days prior to consent\n18. Known pregnancy at consent\n19. Active warfarin use","85 Years",{"count":319,"type":22},5500,[131],"The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.",[323,324,325,28],"Carcinoma, Hepatocellular","Liver Cancer","Liver Cirrhosis",[327,328,329],"Hepatocellular carcinoma surveillance","GALAD","Alpha Fetoprotein","2025-11-25",{"date":301,"type":37},{"date":333,"type":37},"2023-12-26",{"date":335,"type":22},"2034-12-31",{"name":337,"class":74},"University of Texas Southwestern Medical Center",18,{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":129,"phases":349,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":368,"leadSponsor":370,"locationsCount":43},"100427272","phase-1-tlr-9-adjuvanted-vaccination-for-chronic-hepatitis-b-100427272","NCT04843852","TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B","Augmentation of Humoral Immunity Using Toll-Like Receptor (TLR) 9 Adjuvanted HBV Surface Antigen to Enhance Anti-HBSAg Response","BOOST-9","Inclusion Criteria:\n\nIn order to participate in this study, an individual must meet all the following criteria:\n\n1. \\>18 years old\n2. Diagnosed with CHB infection, without HIV, hepatitis C nor hepatitis D co-infections\n3. Currently receiving NUC with HBV VL \\\u003C100 IU\u002Fml for ≥ 12 months\n4. Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.\n5. Determined by medical history, targeted physical examination, and clinical judgement of the investigator to be in good health.\n\nCHB infection is defined as any individual with documentation of a positive HBsAg and\u002For detectable HBV DNA test for at least 6 months.\n\nExclusion Criteria:\n\nA participant will be ineligible to participate on this study if any of the following criteria are met:\n\n1. Pregnancy or breast feeding.\n2. Received systemic immunosuppressants or immune-modifying drugs for \\>14 days in total within 6 months prior to Screening (for corticosteroids ≥ 20 mg\u002Fday of prednisone equivalent). Received anti-CD20 immunosuppressant within 12 months of screening. Topical tacrolimus is allowed if not used within 14 days prior to Day 1.\n3. Received or plans to receive live virus vaccines within 4 weeks, and inactivated vaccine within 2 weeks prior to randomization; or plans to receive a non-study vaccine within 28 days after any dose of study vaccine (with exception for seasonal influenza vaccine within 14 days of study vaccine).\n4. Administration of any blood products within 3 months prior to randomization.\n5. Participation in a study with an investigational study product or device within 30 days of randomization.\n6. Has allergies to any hepatitis B and\u002For yeast-based vaccines.\n7. Subjects meeting any of the following laboratory parameters at screening:\n\n   1. ALT greater than 3 times the upper limit of normal\n   2. Elevated total bilirubin WITH direct bilirubin greater than 2 times upper limit of normal\n8. Is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as ≥ 38.0°C\u002F100.4°F). Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.\n9. Have any chronic or acute or unstable conditions that the investigator considers a contraindication to study participation.",{"count":348,"type":22},10,[190],"The goal of this clinical trial is to learn if HEPLISAV-B, a vaccine that is approved to prevent hepatitis B infection in people that are not already infected, is safe in people already chronically infected with hepatitis B. The main quiestions it aims to answer are:\n\n1. Is HEPLISAV-B safe in people with chronic hepatitis B?\n2. What side effects, if any, could HEPLISAV-B cause in people with chronic hepatitis B?\n3. How does HEPLISAV-B affect the cells that fight chronic hepatitis B?\n\nParticipants will:\n\n* Receive HEPLISAV-B as an injection in the muscle, one injection every 4 weeks, for a total of 2 injections.\n* Visit the clinic a total of 5 times, and have 3 phone follow ups over 14 months.\n* Be asked if they are having any side effects from HEPLISAV-B.\n* Have blood samples collected.",[28,352],"Chronic Hepatitis B",[354,355,356,357,358,359,360,361,362,363],"hepatitis B","Toll-like receptor","vaccine","hepatitis B surface antibody","HBsAb","anti-HBsAg","hepatitis B surface antigen","HBsAg","TLR9","CpG","2025-10-16",{"date":366,"type":37},"2025-10-20",{"date":364,"type":37},{"date":369,"type":22},"2027-04-01",{"name":371,"class":74},"University of Maryland, Baltimore",{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":16,"sex":17,"minAge":82,"maxAge":379,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":43},"100402865","liver-disease-and-other-systemic-diseases-100402865","NCT04525833","Liver Disease and Other Systemic Diseases","The Association of Liver Disease With Other Systemic Diseases, Focus on Diseases Progression, Treatments, and Clinical Outcomes: Analyses From the Hospital Database of Buddhist Tzu Chi Medical Foundation","Inclusion Criteria:\n\n* Individuals who visited the gastroenterology clinics of the Tzu Chi Hospitals, Buddhist Tzu Chi Medical Foundation\n\nExclusion Criteria:\n\n* Age younger than 18 or older than 99 years","99 Years",{"count":381,"type":22},15000,"Examine the association of chronic liver diseases (including hepatitis B, hepatitis C, alcoholic liver disease, fatty liver, liver cirrhosis, and hepatocellular carcinoma) with other systemic diseases by retrospectively analyzing the data from the Hospital Database of Buddhist Tzu Chi Medical Foundation.",[384,385,386,387,388,27,28,389,390,391],"Liver Diseases","Humans","Progression","Carcinogenesis","Fatty Liver Disease","Hepatocellular Carcinoma","Liver Cirrhoses","Treatment Outcome","2025-09-16",{"date":394,"type":37},"2025-09-19",{"date":396,"type":37},"2020-01-01",{"date":398,"type":22},"2026-12-31",{"name":400,"class":74},"Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":16,"sex":17,"minAge":408,"maxAge":4,"enrollmentInfo":409,"targetDuration":411,"studyType":23,"phases":4,"briefSummary":412,"conditions":413,"keywords":420,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":43},"100287699","blood-collection-biorepository-for-liver-disease-research-100287699","NCT03025074","Blood Collection Biorepository for Liver Disease Research","Virology, Immunology and Mechanisms of Liver Disease in Patients With Hepatitis C and Other Liver Diseases","Inclusion Criteria:\n\n* This protocol is to establish a biobank of blood samples from individuals with or without liver diseases including viral hepatitis, liver cancer, NASH, and negative control samples.\n* Children and teenagers will be special populations considered in this protocol.\n\nExclusion Criteria:\n\n* Vulnerable populations such as adults unable to consent, infants, pregnant women or prisoners will not be considered for this research study.","7 Years",{"count":410,"type":22},1000,"1 Day","The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.",[414,27,28,415,416,417,418,419],"Non-Alcoholic Steatohepatitis(NASH)","Fibrosis","Cirrhosis","Fatty Liver","Obesity, Childhood","Bariatric Surgery Candidate",[29,421,422,158,423],"Obesity","Hepatitis","Hepatology","2025-08-20",{"date":426,"type":37},"2025-08-27",{"date":428,"type":4},"2013-07",{"date":430,"type":22},"2099-12",{"name":432,"class":74},"State University of New York at Buffalo",{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":129,"phases":443,"briefSummary":444,"conditions":445,"keywords":451,"overallStatus":278,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":257},"100602632","scalable-public-health-empowerment-research-and-education-sites-spheres-100602632","NCT07126041","Scalable Public Health Empowerment, Research, and Education Sites (SPHERES)","End-to-end Digital Transformation for Primary Health Care Performance Management Via Scalable Public Health Empowerment, Research, and Education Sites: A Stepped-Wedge Cluster Randomized Trial","SPHERES","Inclusion Criteria:\n\n* Residing in or participating in the district catchment areas\n* Receiving services from participating health care facilities\n* Health providers and district health officials consent to participate in data collection\n\nExclusion Criteria:\n\n* Individuals (health workers or patients) who decline to provide informed consent.\n* Individuals who are not directly involved in or accessing services from health care facilities or district health offices.\n* Inability to provide consent due to cognitive impairment or acute illness for health workers or district health officials involved in data collection",{"count":442,"type":22},1750000,[215],"SPHERES is a health service research trial in the Indonesian primary care system designed to improve health system performance using a structured data-driven action model. The intervention empowers district health leaders to make data-informed decisions that will enhance outcomes across maternal, child, infectious, and non-communicable disease programs.",[446,447,448,28,449,450],"Pregnancy","Neonatal Mortality","Tuberculosis","Hypertension","Diabetes Mellitus",[452,453,454,455,456,457,448,28,458,449,459,460,461,462,463],"Primary health care performance","Digital health transformation","Maternal health","Child health","Immunization","Stunting","Diabetes mellitus","Health system strengthening","Indonesia","Health governance","Human resource management","Work culture","2025-08-09",{"date":466,"type":37},"2025-08-15",{"date":468,"type":22},"2025-08-14",{"date":470,"type":22},"2027-03-31",{"name":472,"class":74},"Oxford University Clinical Research Unit Indonesia",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":479,"eligibilityCriteria":480,"healthyVolunteers":16,"sex":481,"minAge":82,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":483,"conditions":484,"keywords":485,"overallStatus":278,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":4},"100599532","pan-viral-screening-and-linkage-to-care-among-gbmsm-and-trans-women-in-spain-100599532","NCT07085715","Pan-Viral Screening and Linkage to Care Among GBMSM and Trans Women in Spain","Optimizing Pan-Viral Screening and Linkage to Treatment and Vaccination Among GBMSM and Trans Women in Spain, Including PrEP Users and Those Awaiting Access: An Online Self-Sampling Pilot Study","PAN-TESTATE","Inclusion Criteria:\n\n* Men self-reporting being gay, bisexual, and other men who have sex with men (GBMSM) or transgender women\n* 18 years old or older\n* Residing in Spain\n* Accepting to participate and signing the informed consent\n* Including those who are in PrEP or waiting access to PrEP; regardless of their HIV status (HIV-negative or HIV-positive), and considered at risk for HCV acute infection using the MOSAIC validated algorithm (score of 2 or higher).\n\nExclusion Criteria:\n\n* \\\u003C18 years old\n* No GBMSM or transgender women\n* Non-residents in Spain\n* No signing the informed consent\n* Not considered at risk for HCV acute infection using the MOSAIC validated algorithm (score lower than 2).","MALE",{"count":213,"type":22},"The World Health Organization (WHO) aims to eliminate viral hepatitis as a public health threat by 2030, with major reductions in hepatitis B and C incidence and mortality. However, hepatitis C virus (HCV) transmission has increased among gay, bisexual, and other men who have sex with men (GBMSM), especially those living with HIV. Practices such as chemsex, particularly involving injection drug use, have contributed to this rise. Hepatitis B virus (HBV) also remains a public health challenge due to the potential for chronic infection and severe liver damage. Hepatitis D virus (HDV), which requires HBV co-infection, further complicates clinical management.\n\nThis study aims to design, implement, and evaluate an online self-sampling testing strategy to enhance pan-viral testing (HBV, HCV, HDV, HIV) and improve linkage to care among GBMSM and transgender women (TW) in Spain.\n\nThe intervention will involve self-collected dried blood spot (DBS) samples for testing HBV surface antigen (HBsAg), HIV antibodies, and HCV RNA. Individuals testing positive for HBsAg will undergo further testing for HBV DNA and HDV infection. Those lacking protective levels of HBV antibodies will be referred for vaccination or revaccination.\n\nThe study will also assess the number of HIV-positive individuals who acquired the infection while waiting for access to PrEP, identifying missed prevention opportunities.\n\nThis non-randomized, single-arm, prospective national study will recruit adult GBMSM and TW through PrEP services, dating apps, NGOs, social media, and community outreach. Participants will complete an online risk assessment (using the HCV-MOSAIC algorithm) and receive self-sampling kits with instructions, lancets, Whatman cards, and prepaid envelopes. Results will be provided online, and those testing positive will be linked to confirmatory diagnosis and care.\n\nOutcomes include estimates of HIV, HBV, HCV, and HDV prevalence; effectiveness of linkage to care; acceptability and usability of the intervention; and validation of DBS for HBsAg detection.\n\nThis study will provide critical evidence on the effectiveness of online self-sampling strategies for viral hepatitis and HIV among GBMSM and TW, supporting Spain's public health goals for prevention, early diagnosis, and linkage to care.",[158,28,27],[486,487],"Self-sampling","Screening","2025-07-24",{"date":490,"type":37},"2025-07-25",{"date":492,"type":22},"2025-10",{"date":494,"type":22},"2026-12",{"name":496,"class":74},"Fundació Institut Germans Trias i Pujol",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":238,"enrollmentInfo":503,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":505,"conditions":506,"keywords":509,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":257},"100599027","real-world-study-evaluating-the-long-term-outcomes-of-pegylated-interferon--2b-treatment-in-the-families-with-clusters-of-hbv-infection-and-unfavorable-prognosis---a-prospective-controlled-multicenter-cohort-study-100599027","NCT07079150","Real-world Study Evaluating the Long-term Outcomes of Pegylated Interferon α-2b Treatment in the Families With Clusters of HBV Infection and Unfavorable Prognosis - A Prospective, Controlled, Multicenter, Cohort Study","Inclusion Criteria:\n\n* Meet the criteria for a family cluster of unfavorable prognoses associated with HBV infection: that is, patients with HBV infection in two consecutive generations of blood relatives, and at least one patient with cirrhosis or HCC in two or more generations of blood relatives;\n* Chronic HBV-infected individuals from families with unfavorable prognoses clustering (meeting either (1)+(2) or (1)+(3) criteria): (1) Positive for HBsAg for more than 6 months; (2) Treated with nucleos(t)ide analogs (NAs); (3) Compensated cirrhosis due to hepatitis B (for details, see the \"Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)\");\n* A negative pregnancy test within 24 hours before the first administration of medication in the treatment group (for women of childbearing age);\n* No contraindications for interferon treatment.\n\nExclusion Criteria:\n\n* Patients diagnosed with liver cancer or other systemic tumors before treatment;\n* Patients with contraindications to Peg IFN α-2b use (for details, see the \"Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)\");\n* Peripheral blood counts: WBC \\\u003C 3.0 × 10\\^9\u002FL, PLT \\\u003C 70 × 10\\^9\u002FL;\n* Liver function: ALT \\> 5 × upper limit of normal (ULN), TBIL \\> 2 × ULN; Individuals planning to receive organ transplantation or who have already undergone organ transplantation;\n* Those allergic to interferon or with any contraindication listed in the product information;\n* Any other conditions deemed unsuitable for enrollment by the investigator.",{"count":504,"type":22},1500,"Chronic hepatitis B can develop into cirrhosis and liver cancer, which seriously endangers the life and health of people. In China, HBV is mainly transmitted from mother to child, showing the phenomenon of family clusters. Similarly, cirrhosis and hepatocellular carcinoma occur in familial clusters. Familial clusters of HBV infection with unfavorable prognoses refers to HBV-infected patients from two consecutive generations of blood relatives, with at least one family member diagnosed with hepatitis B-related cirrhosis or hepatocellular carcinoma (HCC). Previous family investigations have shown that the risk and harm of HBV-related cirrhosis and hepatocellular carcinoma are significantly higher in families with familial clusters of HBV infection with unfavorable prognoses than in the general population.\n\nCurrently, antiviral drugs used for CHB mainly include nucleoside analogues (NAs) and interferon-alpha (mainly pegylated interferon-alpha, Peg IFN). NAs mainly inhibits viral replication by blocking the reverse transcription process, but it cannot effectively inhibit the expression of viral proteins such as HBsAg, and rarely achieves clinical cure. Multiple clinical studies have shown that the use of NAs reduces the incidence of cirrhosis decompensation, HCC, and death in patients with CHB compared to untreated or placebo-treated patients. Despite long-term treatment with first-line NAs drugs, CHB patients continue to be at risk of developing hepatocellular carcinoma. Peg IFN α-2b injection is the first-line drug of choice for antiviral treatment of chronic hepatitis B, and its main mechanism of action includes anti-HBV, anti-fibrosis, anti-tumor and regulation of immune response. In 2024, a randomized controlled multicenter study showed that Peg IFN α-2b combined with NAs therapy could effectively prevent hepatocellular carcinoma in CHB patients. There is sufficient evidence in clinical practice that long-term antiviral therapy, whether NAs or Peg IFN α-2b, reduces the risk of cirrhosis, hepatocellular carcinoma, and death in patients with CHB. In conclusion, early antiviral therapy can reduce the risk of developing hepatitis B cirrhosis and hepatocellular carcinoma in CHB patients with familial clusters of HBV infection with unfavorable prognoses.\n\nThe goal of this observational study is to explore the evaluation of pegylated interferon α-2b combined with first-line NAs on the long-term outcome of CHB antiviral therapy with cirrhosis and HCC progression as the main observation targets, compared with only use of NAs in the context of familial clusters of HBV infection with unfavorable prognoses. It is intended to provide high-quality evidence-based medical evidence for the treatment and follow-up of CHB, explore optimal clinical decision-making, and provide global clinical data for the improvement and evaluation of this difficult-to-treat population. The main question it aims to answer is: Can Peg IFN-α-2B combined with NAs therapy improve the long-term outcomes of this particular population of familial clusters of HBV infection with unfavorable prognoses compared to first-line NAs monotherapy? Patients with familial clusters of HBV infection with unfavorable prognoses using Peg IFN-α-2B combined with NAs therapy and NAs monotherapy will be collected laboratory and medical examination data at specified follow-up points, and recorded adverse events and drug combinations in detail for 7 years.",[507,28,508],"Hepatitis B, Chronic (CHB)","Hepatitis B Virus (HBV)",[354,510,511,512,513,514],"family cluster","interferon","antiviral therapy","cirrhosis","hepatocellular carcinoma","2025-07-14",{"date":517,"type":37},"2025-07-22",{"date":519,"type":37},"2025-01-01",{"date":521,"type":22},"2032-01",{"name":523,"class":74},"First Affiliated Hospital Xi'an Jiaotong University",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":16,"sex":17,"minAge":531,"maxAge":532,"enrollmentInfo":533,"targetDuration":4,"studyType":129,"phases":535,"briefSummary":538,"conditions":539,"keywords":545,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":43},"100588906","phase-2-a-phase-iiiii-study-to-evaluate-the-immunogenicity-safety-and-lot-to-lot-consistency-of-lbvd-a-fully-liquid-hexavalent-diphtheria-tetanus-whole-cell-pertussis-hepatitis-b-poliovirus-haemophilus-influenzae-type-b-conjugate-dtwp-hepb-ipv-hib-vaccine-in-healthy-infants-as-primary-series-100588906","NCT06947499","A Phase II\u002FIII Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series","A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II\u002FIII Clinical Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series","Inclusion Criteria:\n\n* healthy infants from 6 weeks to 8 weeks of age (both inclusive)\n* body weight ≥ 3.2 kg\n* born at full term pregnancy (≥ 37 weeks)\n* signed informed consent by parent(s) or legally acceptable representative(s)\n\nExclusion Criteria:\n\n* Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis\n* Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration\n* Known history of SARS-CoV-2 infection\n* Participant's mother is HepB antigen or HIV positive\n* Fever ≥ 38.0 C\u002F100.4 F within 3 days prior to enrollment\n* Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG)\n* Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination\n* Received immunosuppressive agents or other immune-modifying drugs\n* Previous use of blood or blood-derived products\n* Any history of allergy (hypersensitivity) to any of the vaccine components\n* Participation in another interventional clinical trial within 4 weeks of expected first vaccination","6 Weeks","8 Weeks",{"count":534,"type":22},1186,[536,537],"PHASE2","PHASE3","The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants",[540,541,542,28,543,544],"Diphtheria","Tetanus","Pertussis","Poliomyelitis","Haemophilus Influenzae Type b",[546],"vaccination","2025-06-30",{"date":549,"type":37},"2025-07-03",{"date":551,"type":37},"2025-05-30",{"date":553,"type":22},"2027-04",{"name":555,"class":204},"LG Chem",{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":563,"enrollmentInfo":564,"targetDuration":4,"studyType":129,"phases":566,"briefSummary":567,"conditions":568,"keywords":569,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":578,"locationsCount":580},"100492024","phase-3-a-study-to-investigate-the-safety-and-efficacy-of-undiluted-intravenous-infusion-of-iv-hepabig-inj-100492024","NCT05686759","A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.","A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients","Inclusion Criteria:\n\n1. Aged ≥18 and \\\u003C65 years at the time of signing the consent form\n2. Subjects who had history of liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure and received treatment for prevent hepatitis B recurrence\n3. HBsAg(+) before liver transplantation\n4. Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit\u002F4weeks regimen\n\nExclusion Criteria:\n\n1. Subject with history of anaphylaxis to any component of the investigational product\n2. Pregnant or breast-feeding women\n3. Deficiency of Immunoglobulin A\n4. Clinically significant renal diseases (serum creatinine \\>2.0mg\u002FdL, anuria, renal failure or on dialysis at screening)\n5. Hemophilia\n6. Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus\n7. Subject with history of malignancy within the last 5 years (excluding primary liver cancer)\n8. Subject received estrogen or hormone replacement therapy within 3 months before screening\n9. HBsAg or HBeAg or HBV DNA positive at screening\n10. Anti HBs titer less than below criteria at screening \\\u003C150 IU\u002FL for subject whose HBeAg and HBV DNA were negative(-) before liver transplantation \\>500 IU\u002FL for subject whose HBeAg or HBV DNA were positive(+) before liver transplantation\n11. Subject with history of drug abuse\n12. Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening\n13. Subject who are determined disqualified to join clinical trials by investigator","64 Years",{"count":565,"type":22},105,[537],"The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients",[28],[28,570,571,384],"Liver Transplantation","Hepatitis B Immunoglobulin","2025-06-18",{"date":574,"type":37},"2025-06-25",{"date":576,"type":37},"2023-04-13",{"date":36,"type":22},{"name":579,"class":204},"GC Biopharma Corp",8,{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":588,"minAge":126,"maxAge":589,"enrollmentInfo":590,"targetDuration":4,"studyType":129,"phases":592,"briefSummary":593,"conditions":594,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":599,"leadSponsor":601,"locationsCount":348},"100588895","comparison-of-taf-and-tdf-in-preventing-mother-to-child-transmission-of-hbv-in-pregnancies-with-high-viral-loads-100588895","NCT06947356","Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads","A Multicenter, Prospective, Open-label, Non-inferiority Randomized Controlled Study on the Efficacy of Tenofovir Alafenamide Fumarate vs. Tenofovir Disoproxil Fumarate in Preventing Mother-to-Child Transmission of Hepatitis B Virus in Pregnant Women With High Viral Loads","Inclusion Criteria:\n\n1. Pregnant women aged between 20 and 40 years old\n2. Pregnancy duration between 20 to 28 weeks (screening for eligible patients can start from the 20th week of gestation)\n3. Clinically diagnosed with compensated chronic hepatitis B, HBsAg positive for more than 6 months, with clinical history, signs, and test results consistent with compensated chronic hepatitis B\n4. HBsAg and HBeAg positive in maternal serum during screening\n5. PCR testing shows maternal serum HBV DNA levels exceeding 200,000 IU\u002FmL\n6. Subjects voluntarily agree to undergo treatment according to the study design's drug treatment plan and all other research requirements, and patients consent to strictly avoid pregnancy within 28 weeks postpartum\n7. Patients and their husbands (the biological parents of the child) understand the risks and voluntarily participate in the study. The mother must participate voluntarily and sign a written informed consent document before participating in the study.\n\nExclusion Criteria:\n\n1. Creatinine clearance \\\u003C 100 mL\u002Fmin (calculated using the Cockcroft-Gault method based on serum creatinine and ideal body weight), or hypophosphatemia (below normal range).\n2. History of adverse renal reactions induced by Adefovir or history of Adefovir resistance.\n3. Meeting one of the following criteria: hemoglobin \\\u003C 80 g\u002FL, neutrophil count \\\u003C 1000\u002FμL, ALT \\> 5 times the upper limit of normal, total bilirubin \\> 20 mg\u002FL, albumin \\\u003C 25 g\u002FL, abnormal levels of creatinine or urea nitrogen.\n4. Pregnant women with a history of miscarriage, history of giving birth to a child with congenital malformations, or history of fetal infection with hepatitis B virus.\n5. The biological father of the current pregnancy has chronic hepatitis B.\n6. The investigator assesses that the subject has significant kidney, cardiovascular, pulmonary, or neurological diseases that affect their participation in the study.","FEMALE","40 Years",{"count":591,"type":22},210,[215],"The main objective of this study is to compare the mother-to-infant transmission rates of hepatitis B between pregnant women receiving treatment with tenofovir alafenamide and those receiving treatment with tenofovir disoproxil fumarate, after administering the hepatitis B vaccine and hepatitis B immunoglobulin to their infants at birth. Investigators define the mother-to-infant transmission rate of hepatitis B as the proportion of infants who are HBsAg positive and have serum HBV DNA \\>20 IU\u002FmL at 28 weeks of age among all live births in the experimental group.\n\nAdditionally, this study will also compare the incidence of congenital defects\u002Fmalformations in infants born to mothers treated with tenofovir alafenamide and tenofovir disoproxil fumarate during the perinatal period to assess drug safety.",[28],"2025-05-03",{"date":597,"type":37},"2025-05-07",{"date":595,"type":37},{"date":600,"type":22},"2028-05-01",{"name":602,"class":74},"Guangzhou 8th People's Hospital",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":588,"minAge":611,"maxAge":186,"enrollmentInfo":612,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":614,"conditions":615,"keywords":617,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":43},"100088058","antiretroviral-pregnancy-registry-apr-multi-sponsor-registry-to-detect-any-major-teratogenic-effect-involving-any-of-the-registry-drugs-when-administered-to-pregnant-people-100088058","NCT00404989","Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant People.","Antiretroviral Pregnancy Registry","APR","Eligibility Ages Eligible for Study: People of childbearing potential\n\nInclusion Criteria:\n\n* Country of origin of report\n* Documentation that the registry drug was taken during pregnancy\n* Sufficient information to determine if the pregnancy is being prospectively or retrospectively registered\n* Date the pregnancy was registered\n* Source of report (patient or health care provider)\n* Whether the pregnancy outcome is already known or delivery is still pending\n* Timing of the prenatal exposure to the registry medication (no broader than which trimester)\n* Sufficient patient identifier relevant to reporter to allow for follow-up\n* Was patient involved in a study at the time of prenatal exposure\n* Full reporter contact information (name, address, etc.)\n\nExclusion Criteria:\n\n• People who were not exposed to registry medications during pregnancy","12 Years",{"count":613,"type":22},24258,"The purpose of the Antiretroviral Pregnancy Registry (Registry) is to detect any major teratogenic effect involving any of the Registry drugs when administered to pregnant people. Registration is voluntary and confidential with information obtained from the health care provider. A Registry-assigned identifier allows for follow-up capability. Information on subjects is provided to the Registry prospectively (prior to the outcome of pregnancy being known) through their health care provider, with follow-up obtained from the health care provider after the outcome is determined. Providers are strongly urged to enroll their patients as early in pregnancy as possible to maximize the validity of the data. In addition, the Registry is very interested in assembling a group of providers who are willing to make a commitment to report all of their site's antiretroviral pregnancy exposures to the Registry, thereby assuring all cases can be considered prospective. Providers are encouraged to contact the Registry for more information about this group. The Registry is informed in its analysis by other data, for example, retrospective reports and clinical studies.\n\nGiven the increasing number of medications and more aggressive approach to therapy, more HIV- and hepatitis B-infected people may be treated during pregnancy or become pregnant while under treatment. The paucity of data on use and infant outcomes of antiretroviral therapies during pregnancy makes this Registry an essential component of the ongoing program of epidemiologic studies of the safety of these therapies.\n\nEach year the Registry has enrolled approximately 1300-1700 pregnant people in the US exposed to antiretroviral drugs. This number represents approximately 15% of the 8,700 HIV positive people who give birth to live infants annually in the US.",[616,28],"HIV Infections",[158,56,422,446,618],"Registry","2025-03-26",{"date":621,"type":37},"2025-04-01",{"date":623,"type":4},"1989-01",{"date":625,"type":22},"2099-01",{"name":627,"class":74},"Syneos Health",{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":636,"targetDuration":411,"studyType":23,"phases":4,"briefSummary":638,"conditions":639,"keywords":640,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":257},"100563969","accupower--hbv-performance-evaluation-quant-kit-bioneer-existation-fa-96384-100563969","NCT06623071","Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96\u002F384","Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation™FA 96\u002F384","BIOPERF-HBV","Inclusion Criteria:\n\nThe patient to be included in this study must be able to understand the purpose research, in order to give free and informed consent.\n\n* Subject aged over 18\n* Subject presenting himself at the investigation center and responding to one of these two criteria:\n\n  * Subject presenting with a prescription for determination HBV viral load\n  * Subject with previously confirmed HBV infection by CE marked tests.\n* Subject capable of understanding the aim of the research having given express free and informed consent\n* Subject affiliated to or beneficiary of a social security system\n\nExclusion Criteria:\n\nProtected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative\n\n• Subject participating in another clinical study",{"count":637,"type":22},45,"As part of the CE marking of a hepatitis B diagnostic kit, the South Korean manufacturer Bioneer wishes to set up a performance study in France in accordance with the IVDR (RE 2017\u002F746).\n\nCerba Xpert CRO of the Cerba Healthcare group promoted this performance study by setting up a prospective collection of blood samples from patients with hepatitis B virus and whose viral load is positive. This prospective collection will be carried out in 3 laboratories of the Cerba Healthcare group.",[28],[56],"2025-03-24",{"date":619,"type":37},{"date":644,"type":37},"2024-10-01",{"date":646,"type":22},"2025-05-31",{"name":648,"class":74},"CerbaXpert",{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":16,"sex":17,"minAge":126,"maxAge":656,"enrollmentInfo":657,"targetDuration":4,"studyType":129,"phases":659,"briefSummary":660,"conditions":661,"keywords":664,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":675,"locationsCount":43},"100437020","the-immune-responses-after-hepatitis-b-revaccination-doses-in-a-young-cohort-100437020","NCT04970836","The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort","IRHBRVD","Inclusion Criteria:\n\n1. The actual age at the time of admission was higher than 20 years old and birth year after 1987\n2. Born in Taiwan and had received a full course of hepatitis B vaccines at least three doses at infant period.\n3. Those who have tested negative for hepatitis B surface antibody and surface antigen at baseline\n4. Have never been vaccinated against hepatitis B in childhood and adolescence by questionnaire\n5. Consent to administer 1-2 doses of hepatitis B vaccine according to the assigned group after sharing decision making process\n6. In good health\n\nExclusion Criteria:\n\n1. Those who were previously allergic to hepatitis B vaccine or its components (such as yeast)\n2. Those who have been vaccinated against hepatitis B during childhood and adolescence\n3. Those who have a positive test for hepatitis B surface antibody or a positive test for hepatitis B surface antigen","36 Years",{"count":658,"type":22},240,[215],"This prospective cohort study aims to provide the evidence-based clinical guide to help decide the revaccination doses of hepatitis B vaccine that the high-risk young adults without hepatitis B seroprotective antibodies (anti-HBs titer\\\u003C10 mIU\u002FmL) need to take.",[28,662,663],"Vaccination; Infection","Preventable Disease, Vaccine",[665,666,667,668],"hepatitis B vaccine","revaccination","young adult","booster","2025-03-17",{"date":671,"type":37},"2025-03-20",{"date":673,"type":37},"2021-08-01",{"date":201,"type":22},{"name":676,"class":74},"National Taiwan University Hospital",{"id":678,"slug":679,"hasResults":12,"nctId":680,"briefTitle":681,"officialTitle":682,"acronym":4,"eligibilityCriteria":683,"healthyVolunteers":12,"sex":17,"minAge":126,"maxAge":684,"enrollmentInfo":685,"targetDuration":4,"studyType":129,"phases":687,"briefSummary":688,"conditions":689,"keywords":690,"overallStatus":278,"whyStopped":4,"lastUpdateSubmitDate":694,"lastUpdatePostDateStruct":695,"startDateStruct":697,"completionDateStruct":699,"leadSponsor":701,"locationsCount":4},"100582562","the-effect-of-hot-foot-bath-on-sleep-quality-and-fatigue-100582562","NCT06864923","The Effect of Hot Foot Bath on Sleep Quality and Fatigue","Investigation of the Effect of Hot Foot Bath on Sleep Quality and Fatigue","Inclusion Criteria:\n\n* being over the age of 18,\n* having no disorder which could affect pain perception,\n* having no communication problem, and voluntarily agreeing to participate in the research,\n* Having been admitted to the clinic at least 24 hours ago,\n* Not having a diagnosed sleep disorder,\n* Not having a psychiatric disorder requiring treatment,\n* Not having a problem with vital signs before the application,\n* Not using narcotic drugs in the last 4 hours,\n* Not eating two hours before going to bed at night\n\nExclusion Criteria:\n\n* being under the age of 18\n* not being conscious, refusing to participate in the research or opting to leave the study at any point,\n* Having a problem with vital signs before the application,\n* Having a diagnosed sleep disorder.","80 Years",{"count":686,"type":22},60,[215],"This study will be conducted to investigate the effects of hot foot baths on patients' sleep quality and fatigue severity levels.The study will be conducted in the Gastroenterology clinic of a university hospital in Türkiye. The research sample will consist of 60 adult patients. Patients will be randomly divided into two groups: the intervention and control groups. The intervention group will receive hot foot baths for three consecutive nights starting from the second day of hospitalization. The foot bath will be applied one hour before the patient goes to bed at night. The foot tub will be filled with hot water to approximately 20 cm above the patient's ankle and the temperature of the water will be measured with a water thermometer. The temperature of the water will be kept stable at 41-42°C. This application will be done for 20 minutes. The sleep and fatigue levels of the patients will be measured with measurement tools in the morning (3 times) following each application. No application will be applied to the control group, and sleep and fatigue levels will be measured in a similar manner to the measurement tools applied to the intervention group and the application days.",[28],[691,692,693],"fatigue","sleep quality","foot bath","2025-03-07",{"date":696,"type":37},"2025-03-11",{"date":698,"type":22},"2025-03-05",{"date":700,"type":22},"2025-06-05",{"name":702,"class":74},"Uludag University"]