[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatitis-b-virus-hbv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatitis-b-virus-hbv":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,75,103,132,158],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100636004","phase-4-combating-related-epidemics-in-hcv-100636004",false,"NCT07560046","Combating Related Epidemics in HCV","Combating Related Epidemics in HCV Through Simplified Testing and Treatment. A Cluster Randomized Trial of Point-of-care Hepatitis C Testing and Treatment Among Key Populations","CREST","Inclusion Criteria:\n\n1. Can provide written informed consent or assent\n2. Minimum of 16 years of age\n3. Willing to undergo HIV, HCV, HBV testing\n4. Willing to undergo treatment for HCV and complete study activities\n\nExclusion Criteria:\n\n1. History of HCV treatment for current infection\n2. Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, or clinical evidence per the site PI\n3. Contraindication for treatment with sofosbuvir\u002Fvelpatasvir due to allergy or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry.\n4. History of clinically significant illness or any other major medical disorder that may interfere with participant treatment, assessment, or compliance with study requirements as determined by the site PI\n5. Ongoing need for use of daily proton pump inhibitor (PPI) at doses ≥40 mg of omeprazole (or equivalent). NOTE: PPI can be discontinued or dose reduced to 20 mg\u002Fday of omeprazole (or equivalent) at time of study entry.\n\nRetreatment Inclusion Criteria:\n\n1. Completion of sofosbuvir\u002Fvelpatasvir treatment regimen as enrolled participant in CREST and willingness to receive retreatment. FIB-4 \\& CTP score available within 90-days of retreatment initiation.\n2. Meeting any of the below criteria during post-cessation treatment follow-up. Relapse, defined as HCV RNA \\\u003CLLOQ\u002FD (TD or TND) during and\u002For at end of treatment followed by HCV RNA \\>LLOQ\u002FD or target detected based on qualitative POC test at any time point from end of treatment to 12 weeks after end of treatment OR Re-infection, defined as meeting the primary outcome criteria for SVR4+ followed by HCV RNA \\>LLOQ\u002FD or target detected based on qualitative POC test at any time point beyond meeting SVR4+ OR Post-treatment virologic failure, defined as HCV RNA \\>LLOQ\u002FD at any point after end of treatment (after week 24 visit) or during follow-up, not otherwise meeting definition of relapse or re-infection\n\nRetreatment Exclusion Criteria:\n\n1. Known preexisting (evidence or history of) decompensated liver disease based on: medical diagnosis through medical record, reporting by the participant, clinical evidence per the site PI, or by CTP score ≥7.\n2. Pregnant or breast feeding at time of retreatment with sofosbuvir\u002Fvelpatasvir\u002Fvoxilaprevir.\n3. Contraindication for treatment with sofosbuvir\u002Fvelpatasvir (reinfection) or sofosbuvir\u002Fvelpatasvir\u002Fvoxilaprevir (relapse or virologic failure) due to FDA package insert, allergy, or drug-drug interaction including use of any prohibited concomitant medications within 28 days prior to study entry.\n4. History of clinically significant illness or any other major medical disorder that may interfere with participant treatment, assessment, or compliance with study requirements as determined by the site PI\n5. Ongoing need for use of daily proton pump inhibitor (PPI) at doses ≥40 mg of omeprazole (or equivalent.). NOTE: PPI can be discontinued or dose reduced to 20 mg\u002Fday of omeprazole (or equivalent) at time of study entry.","ALL","16 Years",{"count":20,"type":21},1280,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is a two-arm cluster randomized control trial to evaluate the effectiveness of a single-visit point-of-care (POC) test and treat bundle (intervention arm) compared to the current standard-of-care (SOC, control arm). 1:1 randomization occurs at the site level.",[27,28,29],"HIV - Human Immunodeficiency Virus","Hepatitis B Virus (HBV)","HEPATITIS C (HCV)",[31,32,33,15],"Hepatitis C","Hepatitis B","HIV","NOT_YET_RECRUITING","2026-04-30",{"date":37,"type":38},"2026-05-05","ACTUAL",{"date":40,"type":21},"2026-08-01",{"date":42,"type":21},"2030-12-30",{"name":44,"class":45},"Duke University","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100617366","rapid-hiv-hep-c-and-syphilis-screening-in-a-rural-street-medicine-clinic-100617366","NCT07317687","Rapid HIV, Hep C, and Syphilis Screening in a Rural Street Medicine Clinic","Rapid HIV, Hepatitis C, and Syphilis Screening in a Rural Street Medicine Clinic in West Virginia","Inclusion Criteria:\n\n* Patients of the WVU Medicine Street Medicine team\n\nExclusion Criteria:\n\n* Patients under the age of 18",true,"18 Years",{"count":56,"type":21},200,"OBSERVATIONAL","West Virginia faces rising rates of HIV, hepatitis, and syphilis, particularly among individuals experiencing homelessness, substance use, and mental health challenges. Traditional blood-draw testing for these infections is often hindered by mistrust, logistical barriers, and delays in results. This study, conducted by the West Virginia University (WVU) Street Medicine program, evaluates a rapid, point-of-care fingerstick test for HIV, Hepatitis C, and syphilis that provides results within 10-20 minutes during mobile clinic visits. Participants may choose rapid testing, traditional blood draw (which also includes Hepatitis B screening), or decline testing. All participants will be invited to complete a brief survey about the experiences with screening methods. The goal is to assess whether rapid testing improves screening uptake, linkage to care, and patient satisfaction, ultimately reducing barriers and disease burden in high-risk populations.",[60,29,61,28],"HIV Testing","Syphilis",[63,64],"Street Medicine","Rapid Fingerstick Testing","2026-01-15",{"date":67,"type":38},"2026-01-20",{"date":69,"type":21},"2026-01",{"date":71,"type":21},"2028-01",{"name":73,"class":45},"West Virginia University",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":74},"100607501","phase-4-combined-light-exvivo-and-antivirals-for-recipients-of-lungs-from-hbv-donors-100607501","NCT07189377","Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors","Lung Transplantation Using Hepatitis B Positive Donors to Hepatitis B Negative Recipients Using Ex-Vivo Treatment of Organs: A Safety Trial","CLEAR-HBV","Donor Inclusion Criteria\n\n* Donor lung suitable for transplantation\n* HBV SAg positive and\u002For HBV NAT+ donor\n\nDonor Exclusion Criteria\n\n* HIV positive\n* HTLV 1\u002F2 positive;\n* Any medical issues in the donor that would normally clinically exclude the donor (e.g. history of cancer, evidence of organ dysfunction, etc).\n\nRecipient inclusion Criteria:\n\n* Recipients eligible and listed for lung transplant\n* HBV NAT negative\n* Provides written informed consent\n* Has received at least 3 prior doses of Hepatitis B vaccine or anti-HBs\\>=10 IU\u002FmL\n* Patients with other co-morbid conditions (such as diabetes, autoimmune disease, renal dysfunction) will remain eligible provided they are otherwise medically suitable for transplantation. The exception to this will be patients with significant liver disease as outlined below.\n\nRecipient exclusion Criteria:\n\n* Chronic liver disease with \\> stage 2 fibrosis\n* Participating in another interventional clinical trial\n* Recipient listed for combined transplant (e.g., heart-lung, lung-liver)\n* Known allergy or contraindication to any of the antiviral medications\n* Hepatitis B surface antigen (HBsAg) or Hepatitis B core Ab positive pre-transplant (indicates already HBV infected).\n* HIV positive\n* Patients with a low level of serum IgA pre-transplant (this may be a risk factor for sensitivity reaction to HBIG).",{"count":84,"type":21},20,[24],"The aim of the study is to show that transplantation of lungs from Hepatitis B-infected donors is safe when using EVLP with UV light inactivation plus antivirals",[28,88],"Lung Transplant Recipient",[90,91,92],"HBV Disease","EVLP","lung transplant","RECRUITING","2025-11-13",{"date":96,"type":38},"2025-11-17",{"date":98,"type":38},"2025-09-24",{"date":100,"type":21},"2027-08",{"name":102,"class":45},"University Health Network, Toronto",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"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.","70 Years",{"count":111,"type":21},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.",[114,32,28],"Hepatitis B, Chronic (CHB)",[116,117,118,119,120,121],"hepatitis B","family cluster","interferon","antiviral therapy","cirrhosis","hepatocellular carcinoma","2025-07-14",{"date":124,"type":38},"2025-07-22",{"date":126,"type":38},"2025-01-01",{"date":128,"type":21},"2032-01",{"name":130,"class":45},"First Affiliated Hospital Xi'an Jiaotong University",2,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":4},"100597050","the-impact-of-treatment-for-chronic-hepatitis-b-virus-on-non-clinical-harms-100597050","NCT07053449","The Impact of Treatment for Chronic Hepatitis B Virus on Non-clinical Harms","The Impact of Treatment for Chronic Hepatitis B Virus on Non-clinical (Social) Harms Amongst Migrant Populations: A Qualitative Study. (B-SOCIAL)","B-SOCIAL","Inclusion Criteria:\n\n* Chronic HBsAg\n* Able to give informed consent in English\n* Able to converse in English\n* Any migrant population member (non-UK) including if born overseas or in the UK\n* Aged 18 years and over\n* Has never taken antiviral treatment for HBV (12-15 participants)\n* Prescribed and taking any oral treatment for HBV for a minimum of 12 months (12-15 participants)\n\nExclusion Criteria:\n\n* Emotionally distressed due to HBV diagnosis\n* Current episode of decompensated cirrhosis\n* Current diagnosis of hepatocellular carcinoma",{"count":141,"type":21},30,"The goal of this qualitative study is to explore the impact of antiviral treatment, or none, for chronic hepatitis B virus on the non-clinical (social) harms experienced by migrant populations living in the UK.\n\nTwo groups of participants living with hepatitis B virus will be interviewed, those taking the daily treatment, and those not prescribed any treatment.",[28],[145,146,147,148],"Hepatitis B Virus","Qualitative","Lived Experience","Stigma","2025-07-11",{"date":151,"type":38},"2025-07-16",{"date":153,"type":21},"2025-08",{"date":155,"type":21},"2026-03",{"name":157,"class":45},"Nottingham University Hospitals NHS Trust",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":166,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":171,"conditions":172,"keywords":176,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100595931","community-screening-and-management-of-hepatitis-b-c-and-delta-in-the-mongolian-population-living-in-france-100595931","NCT07038863","Community Screening and Management of Hepatitis B, C and Delta in the Mongolian Population Living in France","Community Screening for Hepatitis B, C and Delta in the Mongolian Population Living in France","Mondelta","Inclusion Criteria:\n\n* Mongolian people\n* Over 15 years of age\n* Living in France\n* Majors agree to participate or minors whose parental guardians agree to their child's participation in the study\n\nExclusion Criteria:\n\n* People already followed for viral hepatitis, treated or not treated\n* Persons deprived of their liberty by a judicial or administrative decision\n* Adults subject to a legal protection measure (guardianship, curators)\n* People participate in any interventional research except routine care research (old regulation) and category 2 research that does not interfere with the primary endpoint analysis","15 Years",{"count":168,"type":21},2000,[170],"NA","In Mongolia, mortality from hepatocellular carcinoma (HCC) is one of the highest in the world. Viral hepatitis is the main cause of HCC: the prevalence of hepatitis B (HBV) estimated at 11% In Mongolia, hepatitis C (HCV) at 8.5%, and hepatitis Delta (HDV) at 40-60% in HBV-infected patients. Viral hepatitis are essentially asymptomatic and therefore require systematic screening for diagnosis. Once a diagnosis of chronic viral infection has been established, specific therapies are available to reduce the morbidity and mortality of these patients. A study carried out in California in the Mongolian community found an HBV prevalence of 9.7% and positive HDV serology in 41% of these patients.\n\nThere is a large Mongolian community in France, estimated at between 5,000 and 6,000 patients. Although the majority of these patients are covered by French social security; however, access to care and screening for viral hepatitis often remain difficult and insufficient for migrant or vulnerable populations in France The aim of this study is to screen the Mongolian community in France for viral hepatitis, and then initiate a program of care and treatment.",[29,28,173,174,175],"Hepatitis D","Hepatocellular Carcinoma (HCC)","Liver Fibrosis",[177,178,179,180],"HBV","HCV","HDV","HCC","2025-06-18",{"date":183,"type":38},"2025-06-26",{"date":185,"type":21},"2025-09-01",{"date":187,"type":21},"2028-05-01",{"name":189,"class":45},"Hospices Civils de Lyon",11]