[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatitis-b-virus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatitis-b-virus":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,71,97,118,139,167],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100505095","phase-1-hepb-mab19-in-individuals-with-chronic-hepatitis-b-infection-100505095",false,"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.","ALL","18 Years","70 Years",{"count":20,"type":21},37,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","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).",[27,28],"Hepatitis b Virus","Hepatitis B",[30,31,32],"monoclonal antibody","HBV","HepB mAb19","RECRUITING","2026-01-29",{"date":36,"type":37},"2026-02-02","ACTUAL",{"date":39,"type":37},"2023-08-07",{"date":41,"type":21},"2028-03-30",{"name":43,"class":44},"Rockefeller University","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100613485","phase-2-a-prospective-study-to-evaluate-the-efficacy-and-safety-of-entecavir-odt-conversion-in-stable-liver-transplant-patients-100613485","NCT07267208","A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients","Inclusion Criteria:\n\n1. Patients aged 19 years or older.\n2. Patients who have maintained stable liver graft function for one year after liver transplantation due to HBV and meet the following conditions:\n\n   1. AST and ALT \\\u003C 35IU\u002FL\n   2. HBsAg: Negative\n   3. HBV DNA: Not detected\n3. Patients who have been taking entecavir for HBV prophylaxis for at least 1 year.\n4. Patients with a tacrolimus trough level maintained between 3-10 ng\u002FmL. 5 .Patients who have voluntarily decided to participate in the clinical trial after fully understanding the detailed explanation of the trial and have provided written consent.\n\nExclusion Criteria:\n\n1. Patients who have undergone transplantation of organs other than the liver or re-transplantation.\n2. Patients who have received bioartificial liver system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation.\n3. Patients with concurrent viral infections (HCV, HIV).\n4. Patients with eGFR \\\u003C30 or those undergoing dialysis\n5. Pregnant or breastfeeding women.\n6. Patients or their spouses\u002Fpartners who do not agree to use medically acceptable and appropriate contraception methods\\* during the clinical trial period.\n\n   \\* Appropriate contraception methods: hormonal contraception, intrauterine device (IUC or IUS), tubal ligation, tubal occlusion, hysterectomy, vasectomy, double barrier methods (combined use of male or female condoms with cervical caps, diaphragms, or contraceptive sponges), single barrier methods with spermicide.\n7. Patients with a history of hypersensitivity to Entecavir.\n8. Patients who are deemed unsuitable for participation in the clinical trial by the investigator.","19 Years",{"count":54,"type":21},82,[56],"PHASE2","This clinical study aims to evaluate the efficacy and safety of switching to entecavir orally disintegrating tablets (ETV-ODT) in liver transplant recipients with chronic hepatitis B, with a particular focus on the impact of the conversion on renal function.\n\nAfter providing written informed consent, participants will undergo screening assessments to determine eligibility based on the inclusion and exclusion criteria. Eligible participants who receive the investigational product will visit the study site at predetermined time points over a 48-week period to complete the scheduled study procedures.",[59,60],"Hepatitis B Virus","Liver Transplant","NOT_YET_RECRUITING","2025-11-24",{"date":64,"type":37},"2025-12-05",{"date":66,"type":21},"2025-12-01",{"date":68,"type":21},"2027-12-31",{"name":70,"class":44},"Jongman Kim",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100583815","impact-of-hepatitis-b-virus-on-inflammatory-bowel-disease-100583815","NCT06881238","Impact of Hepatitis B Virus on Inflammatory Bowel Disease","The Impact of Hepatitis B Virus Infection on the Clinical Course of Inflammatory Bowel Disease in Egyptian Patients","Inclusion Criteria:\n\n* Male or female patients older than 18 years.\n* Patients with IBD are diagnosed by clinical, radiological, endoscopic, and histological criteria.\n\nExclusion Criteria:\n\n* Patients aged \\\u003C 18 years\n* Unwilling to participate in our study",{"count":79,"type":21},162,"OBSERVATIONAL","The goal of this observational retrospective study is to assess the impact of hepatitis B virus (HBV) infection on the clinical course and outcomes of inflammatory bowel disease (IBD) in Egyptian patients.\n\nResearchers will compare the IBD extent, location, severity, and behavior between IBD patients with and without HBV infection.\n\nParticipants will be subjected to history-taking (history of hospital admission and disease flare, surgical history, medication history, follow-up duration, and mortality), clinical examination, laboratory investigations, abdominal ultrasonography, and endoscopic examination.",[83,59],"Inflammatory Bowel Disease (IBD)",[85,86],"Hepatitis b virus","Inflammatory bowel disease course","2025-03-11",{"date":89,"type":37},"2025-03-18",{"date":91,"type":37},"2024-12-01",{"date":93,"type":21},"2025-06-10",{"name":95,"class":44},"Tanta University",1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100561388","phase-2-to-evaluate-the-efficacy-and-safety-of-tenofovir-alafenamide-conversion-in-liver-transplant-patients-100561388","NCT06589518","To Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients","A Prospective, Single Center Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients","Inclusion Criteria:\n\n1. Patients aged 19 years or older.\n2. Patients who have maintained stable liver graft function for one year after liver transplantation due to HBV and meet the following conditions:\n\n   ALT \\\u003C 3 x ULN and AST \\\u003C 3 x ULN\n3. Patients taking antiviral therapy other than TAF for HBV prophylaxis.\n4. Patients with a tacrolimus trough level maintained between 3-10 ng\u002FmL.\n5. Patients who have voluntarily decided to participate in the clinical trial after fully understanding the detailed explanation of the trial and have provided written consent.\n\nExclusion Criteria:\n\n1. Patients who have undergone transplantation of organs other than the liver or re-transplantation.\n2. Patients who have received BAL system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation.\n3. Patients with concurrent viral infections (HCV, HIV).\n4. Patients taking mTOR inhibitors (e.g., Everolimus (Certican), etc.).\n5. Patients with eGFR \\\u003C30 or those undergoing dialysis.\n6. Pregnant or breastfeeding women.\n7. Patients or their spouses\u002Fpartners who do not agree to use medically acceptable and appropriate contraception methods\\* during the clinical trial period.\n\n   * Appropriate contraception methods: hormonal contraception, intrauterine device (IUC or IUS), tubal ligation, tubal occlusion, hysterectomy, vasectomy, double barrier methods (combined use of male or female condoms with cervical caps, diaphragms, or contraceptive sponges), single barrier methods with spermicide.\n\n     8 . Patients with a history of hypersensitivity to Tenofovir. 9 . Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.\n\n10\\. Patients who are deemed unsuitable for participation in the clinical trial by the investigator.",{"count":105,"type":21},108,[56],"This clinical trial aims to confirm the efficacy and safety of Vemlia® tablets (Tenofovir alafenamide) in liver transplant patients with hepatitis B, focusing on their effects on renal function.\n\nHBV reactivation post-liver transplantation can result in a post-transplant mortality rate of up to 50% within two years, making prophylaxis critical. Currently, a combination therapy of HBIG and nucleotide analogues is commonly used. Among the nucleotide analogues (NA), entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are frequently used as first-line therapies. However, both ETV and TDF have nephrotoxicity, requiring caution in patients with chronic kidney disease. Specifically, 18% of liver transplant patients develop chronic kidney disease due to immunosuppressant use, making the appropriate use of antiviral drugs to preserve renal function crucial.\n\nTAF has been reported through RCTs to be more effective than TDF in preserving renal function and bone density, while showing similar antiviral effects. However, these studies have been conducted exclusively on general chronic liver disease patients. Although multicenter studies have been reported for liver transplant patients, they were retrospective and involved a limited number of patients.\n\nTherefore, the primary objective of this study is to assess the impact of converting to TAF on renal function preservation in liver transplant patients taking antivirals for HBV prophylaxis. The secondary objectives are to evaluate the antiviral effect on HBV, the impact on lipid profiles, and the effectiveness in preserving bone density.",[59,60,109],"Renal Insufficiency","2025-02-03",{"date":112,"type":37},"2025-02-04",{"date":114,"type":21},"2025-03-01",{"date":116,"type":21},"2026-06-30",{"name":70,"class":44},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100569220","phase-3-obeticholic-acid-among-chronic-hbv-patients-with-hepatic-steatosis--clinical-and-portal-doppler-outcomes-100569220","NCT06691412","Obeticholic Acid Among Chronic HBV Patients with Hepatic Steatosis : Clinical and Portal Doppler Outcomes","Inclusion Criteria:\n\n* Patients 18 years of age or older who had diagnosed as chronic HBV on treatment with with Controlled Attenuation Parameter (CAP) value more than 238 dB\u002Fm .\n\nExclusion Criteria:\n\n* patients under the age of 18.\n* patients with other viral hepatitis infection .\n* Hepatocellular carcinoma .\n* portal vein thrombosis.\n* Subjects with risk of 2nd hepatic steatosis liver disease (excessive alcohol consumption and medications).\n* history of liver disease such as (α-1 antitrypsin deficiency, autoimmune hepatitis, drug-induced liver injury, 1ry biliary cirrhosis, 1ry sclerosing cholangitis).\n* Body Mass Index (BMI) \\> 35 (to avoid the possibility of Fibroscan failure).\n* Patient with end organ disease.",{"count":125,"type":21},100,[127],"PHASE3","In this study, the investigators aimed to evaluate the hepatoprotective effect of OCA against HBV-induced liver injury by comparing patients demographic , laboratory date ( liver function , viremia ) , degree of hepatic steatosis and fibrosis and portal doppler at the beginning and after six months .",[59,130],"Steatosis","2024-11-14",{"date":133,"type":37},"2024-11-15",{"date":133,"type":21},{"date":136,"type":21},"2026-03-01",{"name":138,"class":44},"Assiut University",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":96},"100380282","nucleoside-acid-analogues-treatment-in-patients-with-normal-alt-and-positive-hbvdna-100380282","NCT04231565","Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.","Study on Therapeutic Effects and Safety of Nucleoside (Acid) Analogues Treatment in Patients With Chronic Hepatitis B With Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA: a Randomized Controlled Trial","ALTHBV","Inclusion Criteria:\n\n* Positive hepatitis b surface antigen and hepatitis b antibody \\> 0.5 year;\n* Age from 18 to 65 years old;\n* Serum Alanine Aminotransferase(ALT) ≤1×ULN at least 12 weeks;\n* Positive Hepatitis b virus(HBV);\n* Do not receive nucleotide\u002Fnucleoside analogues or interferon treatment in the past half year.\n\nExclusion Criteria:\n\n* Other active liver diseases;\n* Hepatocellular carcinoma or other malignancy;\n* Pregnancy or lactation;\n* Human immunodeficiency virus infection or congenital immune deficiency diseases; 5.Severe diabetes, autoimmune diseases; 6.Other important organ dysfunctions; 7.Using glucocorticoid; 8.Patients can not follow-up; 9.Investigator considering inappropriate.","65 Years",{"count":149,"type":21},200,[151],"NA","This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.",[59],[155,156,157],"hepatitis B virus","nucleoside","nucleotide","2024-02-28",{"date":160,"type":37},"2024-03-01",{"date":162,"type":37},"2020-06-04",{"date":164,"type":21},"2027-07-01",{"name":166,"class":44},"Third Affiliated Hospital, Sun Yat-Sen University",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":176,"studyType":80,"phases":4,"briefSummary":177,"conditions":178,"keywords":182,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":4},"100497103","a-novel-biomarker-for-response-and-prognosis-of-hbv-related-hepatocellular-carcinoma-100497103","NCT05752890","A Novel Biomarker for Response and Prognosis of HBV-related Hepatocellular Carcinoma","Developing a Novel Biomarker for Response and Prognosis of HBV-related Hepatocellular Carcinoma Treated With Radiotherapy: Personalized Cell-free Virus-host Chimera DNA","Inclusion Criteria:\n\n1. Patients diagnosed with HCC by dynamic image criteria and\u002For biopsy\n2. HBsAg (+)\n3. Child-Turcotte-Pugh (CTP) class A-B liver function\n4. Radiotherapy to liver tumor as the main treatment\n\nExclusion Criteria:\n\n1. Child-Turcotte-Pugh (CTP) class C liver functiECOG performance status score \\>2\n2. Has had prior radiotherapy to the proposed treatment field.\n3. \\\u003C 18 years old",{"count":175,"type":21},95,"3 Months","The investigators will first use our previously collected serum samples and surgical\u002Fbiopsied tissues from HBV-related HCC patients undergoing radiotherapy. The consistency of junctional clones by Capture NGS needs to be tested between both pre- and post-RT serums, and serial changes in copy numbers of vh-DNA by ddPCR are quantified in the representative cases. The same junction clones from pre-post-RT serums and surgical tissues will be confirmed and the copy number changes of vh-DNA be correlated with RT response and disease-control status.\n\nThe investigators plan to identify HBV integrations by Capture NGS and quantify the specific vh-DNA by ddPCR as personalized biomarkers from the same-patient serum samples. The investigators will further correlate clinical response and recurrence\u002Fmetastasis with serial changes of vh-DNA copy numbers. The investigators have been prospectively collecting plasma samples from HBV-related HCC patients before\u002Fafter RT, at 1, 4, 7 months, and at recurrence\u002Fmetastasis. The investigators plan to confirm the viable role of pre-\u002Fpost-RT changes of plasma vh-DNA copies of the same junction clone in post-RT response and prognosis. Moreover, The investigators will explore the recurrent\u002Fmetastatic tumors arising from the original or a de novo one by identifying their clonality with HBV integration patterns. The true value of this novel HBV chimera vh-DNA will be revealed. The results will also support the consolidative use of personalized vh-DNA for earlier evaluating treatment response after RT, for post-RT disease monitoring, and for differentiating clonality at recurrence to design future clinical trial on combinational treatment.",[179,27,180,181],"Hepatocellular Carcinoma","Radiotherapy","Biomarker",[179,27,180,183,181],"Chimera DNA","2023-02-21",{"date":186,"type":37},"2023-03-03",{"date":188,"type":21},"2023-03-01",{"date":190,"type":21},"2031-01-31",{"name":192,"class":44},"National Taiwan University Hospital"]