[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-hbv-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-hbv-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,72,95],{"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":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100606747","phase-1-study-of-lw231-in-participants-with-chronic-hepatitis-b-100606747",false,"NCT07179575","Study of LW231 in Participants With Chronic Hepatitis B","Phase Ib\u002FII Study of LW231 in Patients With Chronic Hepatitis B: Evaluation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy With Multiple-Dose, Dose-Escalation, and Combination With Nucleos(t)Ide Analogs (NUC)","Inclusion Criteria:\n\n* Part 1: treatment-naïve and currently not treated subjects: LLOQ\\\u003CHBV DNA≤20000 IU\u002Fml; 100 IU\u002FmL\\\u003CHBsAg\\\u003C10000 IU\u002Fml\n* Part 2: HBV DNA\\\u003CLLOQ or \\\u003C 20 IU\u002FmL at screening; 100 IU\u002FmL\\\u003CHBsAg\\\u003C3000 IU\u002FmL\n\nExclusion Criteria:\n\n* Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.\n* History or current evidence of cirrhosis.\n* ALT or AST\\>3×ULN; TBil\\>1.3×ULN or DBil\\>1.3×ULN; INR\\>1.3×ULN","ALL","18 Years","60 Years",{"count":20,"type":21},270,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a Phase Ib\u002FII, multicenter, randomized, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of LW231 in participants with chronic hepatitis B virus (HBV) infection. The trial will include multiple-dose regimens of LW231 and assess LW231 in combination with NUCs.",[28],"Chronic HBV Infection","RECRUITING","2025-09-28",{"date":32,"type":33},"2025-10-02","ACTUAL",{"date":35,"type":21},"2025-10",{"date":37,"type":21},"2027-11",{"name":39,"class":40},"Shanghai Longwood Biopharmaceuticals Co., Ltd.","INDUSTRY",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100584261","phase-2-methylene-blue-treatment-of-chronic-hepatitis-b-virus-infection-100584261","NCT06887036","Methylene Blue Treatment of Chronic Hepatitis B Virus Infection","Methylene Blue Treatment of Chronic Hepatitis B Virus Infection: a Pilot Study","MB_HBV","Inclusion Criteria:\n\n* Signed informed consent\n* Age ≥ 18 and \\\u003C 80 years\n* Microbiologically confirmed chronic Hepatitis B Virus infection (according to the old terminology \"inactive HBV carrier\")\n* HBsAg levels within 20-15'000 IU\u002Fml measured at the at least twice at 6-18 months apart\n* HBV DNA PCR levels within 1'000-20'000 IU\u002Fml measured at least twice at 6-18 months apart\n* Negative pregnancy test in women of child-bearing age\n\nExclusion Criteria:\n\n* Documented refusal to participate in the study\n* Known G-6-Phophatase deficiency\n* Treatment with a serotoninergic drug\n* Ongoing treatment with a nucleos(-t)ide treatment\n* Clinically relevant concomitant liver disease\n* GPT \\> 2xULN\n* Fibroscan of \\> 8.0 KPa obtained ≤ 12 months before Visit 0\u002FScreening\n* HBeAg positivity\n* Anti HDV antibody positivity\n* Breastfeeding women","79 Years",{"count":52,"type":21},10,[25],"HBV infection is a global public health problem. It is estimated that there are more than 250 million HBV carriers worldwide, of whom approximately 600,000 die each year from HBV-related liver disease. Diagnosis and treatment depend on the stage of infection, the degree of liver inflammation, and the progression of fibrosis. Patients with HBeAg-positive or -negative hepatitis are usually treated with nucleos(-t)ide analogues. This treatment inhibits HBV reverse transcriptase and reduces viral replication, but does not affect HBsAg production. Treatment must be continued for life in most cases and is associated with high cumulative costs and the risk of development of resistance.\n\nRecently, it has been shown that patients who show a decrease in their HBsAg levels are more likely to become HBsAg negative, seroconvert and be able to stop antiviral treatment, which is the ultimate goal of treatment, but unfortunately rarely achieved. Methylene blue (MB) has been shown to have an effect on HBsAg levels in vitro, making it a promising test for a new treatment for HBV.\n\nThis is an explorative pilot study, open label, dose-escalation, single center clinical trial on the efficacy of MB against HBV infection.\n\nPrimary objective is to assess the efficacy of incremental doses of MB against hepatitis B virus in patients with chronic hepatitis B assessed by the reduction of both the HBsAg and HBV DNA levels after 6 months of treatment and 6 months of follow-up.\n\nParticipant will be treated for 6 months with MB 100 mg capsules, and then followed up for a further 6 months. The initial dose of MB might be increased if the patient is a non-responder.",[28],[57,58,59,60],"HBV","chronic HBV","Methylene Blue","MB","2025-08-13",{"date":63,"type":33},"2025-08-17",{"date":65,"type":21},"2025-09",{"date":67,"type":21},"2026-10-31",{"name":69,"class":70},"Fondazione Epatocentro Ticino","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":71},"100592208","effect-of-long-term-use-of-tenofovir-tdf-on-bone-density-in-patients-with-chronic-hepatitis-b-100592208","NCT06990438","Effect of Long-Term Use of Tenofovir (TDF) on Bone Density in Patients With Chronic Hepatitis B","Inclusion Criteria:\n\n\\-\n\nInclusion Criteria:\n\nAdult male or female patients aged 18 to 60 years.\n\nDiagnosed as HBV-positive.\n\nLong-term use of Tenofovir Disoproxil Fumarate (TDF) for more than five years.\n\nExclusion Criteria:\n\nPresence of other chronic liver diseases.\n\nDiagnosed with Chronic Kidney Disease (CKD), regardless of etiology.\n\nPatients who refuse to participate in the study.\n\nPatients on combination therapy, including:\n\nInterferon and Nucleoside analogue combination therapy.\n\nMultiple nucleoside analogue combination therapy.\n\n\\-",{"count":79,"type":21},172,"OBSERVATIONAL","This study aims to evaluate the effect of long-term use of Tenofovir Disoproxil Fumarate (TDF) on bone density in patients with chronic hepatitis B virus (HBV) infection. Tenofovir is a widely used antiviral medication for the treatment of HBV. While it is generally well tolerated, some studies have reported potential adverse effects on bone mineral density, particularly with long-term use.\n\nThe objective of this research is to assess whether extended TDF therapy is associated with reduced bone density or increased risk of osteopenia or osteoporosis in adult patients with chronic HBV infection. The study will involve clinical evaluation and radiological assessment of bone health using dual-energy X-ray absorptiometry (DEXA) scans, as well as relevant biochemical markers.\n\nThis investigation will provide important data on the long-term safety profile of Tenofovir in relation to bone health and help guide future clinical decisions for the management of chronic hepatitis B.",[83,84,28],"Tenofovir Disoproxil Fumarate","Bone Density","NOT_YET_RECRUITING","2025-05-17",{"date":88,"type":33},"2025-05-25",{"date":90,"type":21},"2025-05-22",{"date":92,"type":21},"2026-06-01",{"name":94,"class":70},"Assiut University",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":102,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":71},"100584997","effect-of-tenofovir-tdf-on-renal-function-in-patients-with-chronic-hepatitis-b-100584997","NCT06896630","Effect of Tenofovir (TDF) on Renal Function in Patients With Chronic Hepatitis B","Effect of Long-Term Use of Tenofovir (TDF) on Renal Function in Patients With Chronic Hepatitis B","Inclusion Criteria:\n\nAdult male or female patients aged 18 to 60 years.\n\nDiagnosed as HBV-positive.\n\nLong-term use of Tenofovir Disoproxil Fumarate (TDF) for more than five years.\n\nExclusion Criteria:\n\nPresence of other chronic liver diseases.\n\nDiagnosed with Chronic Kidney Disease (CKD), regardless of etiology.\n\nPatients who refuse to participate in the study.\n\nPatients on combination therapy, including:\n\nInterferon and Nucleoside analogue combination therapy.\n\nMultiple nucleoside analogue combination therapy.",{"count":79,"type":21},"Effect of Long-Term Use of Tenofovir (TDF) on Renal Function in Patients with Chronic Hepatitis B Over a Five-Year Period",[83,105,28],"Renal Function Disorder","2025-04-02",{"date":108,"type":33},"2025-04-04",{"date":110,"type":21},"2025-04-10",{"date":112,"type":21},"2026-05-01",{"name":94,"class":70}]