[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hbv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hbv":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,48,74,106,137,159,191,218,241,266,291,310,329,360,383,403],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100580198","non-interventional-study-to-assess-the-number-of-people-with-untreatedunknown-hbv--hdv-and-hcv-in-south-east-austria-100580198",false,"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)","ALL",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","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.",[24,25,26,27,28,29],"HBV","HCV","HDV","Coinfection","Hepatitis B Coinfection","Hepatitis B",[24,25,26,31,32,29,33,34],"Hepatitis B and D coinfection","untreated hepatitis","Hepatitis C","Hepatitis treatment","RECRUITING","2026-06-17",{"date":38,"type":39},"2026-06-18","ACTUAL",{"date":41,"type":39},"2025-05-01",{"date":43,"type":20},"2026-10",{"name":45,"class":46},"Vanessa Stadlbauer-Koellner, MD","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":59,"studyType":21,"phases":4,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100633629","hbv-reactivation-in-immunocompromised-patients-reant-study-100633629","NCT07529171","HBV Reactivation in Immunocompromised Patients (REANT STUDY)","Management and Monitoring of HBV Reactivation in Immunocompromised Patients in Turkey (REANT STUDY)","Inclusion Criteria:\n\n* Aged 18 years or older\n* Positive for Anti-HBc IgG\n* Must be candidate for immunosuppressive therapy.\n\nExclusion Criteria:\n\n* Voluntary Withdrawal\n* Failure to attend follow-up visits","18 Years","80 Years",{"count":58,"type":20},490,"48 Months","Background\u002FObjective: Comorbidities represent a critical risk factor in the prognosis of patients receiving immunosuppressive therapy. For patients with anti-HBc IgG positivity requiring Hepatitis B virus (HBV) prophylaxis, the long-term physiological impact of oral antivirals remains a concern. This study aims to prospectively monitor bone, renal, and metabolic dysfunctions associated with oral antiviral use and other systemic risk factors over a long-term period.\n\nMethods: The REANT Cohort is designed as a 4-year, multicenter prospective study. The cohort will consist of patients initiated on HBV prophylaxis due to immunosuppressive treatment. Participants will undergo regular longitudinal assessments to evaluate bone mineral density, renal filtration and tubular functions, and metabolic profiles. The interplay between antiviral therapy, baseline comorbidities, and long-term organ dysfunction will be analyzed.\n\nConclusion: The findings from the REANT Cohort are expected to provide robust evidence regarding the safety of long-term HBV prophylaxis and assist in the development of monitoring guidelines for immunosuppressed patients with latent HBV infection.",[24],[63,64],"HBV reactivation","Immunosuppressive therapy","2026-04-09",{"date":67,"type":39},"2026-04-14",{"date":69,"type":39},"2026-03-09",{"date":71,"type":20},"2029-12-31",{"name":73,"class":46},"Yaşar Bayındır, MD",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":84,"conditions":85,"keywords":93,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":47},"100625994","changes-in-bile-acids-and-microbiota-in-patients-with-hepatitis-d-treated-with-bulvertide-100625994","NCT07429864","Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide","Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection","Bio-Delta","Inclusion Criteria:\n\n* Patients with chronic HDV-related hepatitis or compensated liver cirrhosis (Child-Pugh class A)\n* Positive HDV RNA within the 24 weeks prior to enrollment\n* Ongoing antiviral therapy for HBV at the time of enrollment\n* First prescription of Bulevirtide 2 mg issued within 30 days prior to enrollment\n* Caucasian ethnicity\n* Age ≥18 years\n* Normocaloric omnivorous diet\n* No intake of antibiotics, probiotics, or prebiotics in the month prior to enrollment\n* Signed informed consent\n\nExclusion Criteria:\n\n* Decompensated liver cirrhosis (Child-Pugh Score B or C)\n* Patients without HBV-HDV-related infection\u002Fhepatitis\u002Fcirrhosis\n* Age ≤18 years\n* Pregnant or breastfeeding women\n* Concomitant diseases with short life expectancy (solid or hematologic neoplasms, heart failure NYHA III\u002FIV, COPD GOLD C-D)\n* Conditions (celiac disease, chronic inflammatory bowel diseases) or use of medications (antibiotics, probiotics, prebiotics) capable of altering gut microbiota composition",{"count":83,"type":20},20,"HDV is an RNA virus that infects only in the presence of HBV, affecting about 13% of HBsAg carriers. In Italy, prevalence ranges from 3.2% to 9.3%. It increases the risk of cirrhosis, fulminant hepatitis, and HCC, particularly in high-risk groups (HIV, HCV, drug users, dialysis patients). Until 2020, pegIFN was the only therapy; since 2022, bulevirtide (BLV) has been available, blocking viral entry into hepatocytes and reducing HDV RNA and liver stiffness, with efficacy in 45-48% of patients, though the optimal treatment duration remains uncertain. The gut microbiota and bile acids also play a role in fibrosis and cirrhosis progression: dysbiosis, typical in cirrhotic patients, alters bile acid metabolism and increases intrahepatic toxicity.",[24,86,25,87,88,89,90,91,92],"HBV Coinfection","HIV Infections","Hepatocellular Carcinoma","Cirrhosis, Liver","Fibrosis, Liver","Bile Acid Malabsorption","Microbial Colonization",[94,95,96],"gut microbiota","Bile Acids","dysbiosis","2026-02-17",{"date":99,"type":39},"2026-02-24",{"date":101,"type":39},"2025-09-24",{"date":103,"type":20},"2027-10",{"name":105,"class":46},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":117,"conditions":118,"keywords":123,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":136},"100606069","clinical-performance-evaluation-of-magia-ivd-md-multiplex-testing-hivhbvhcvsyphilis-100606069","NCT07170748","Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV\u002FHBV\u002FHCV\u002FSyphilis)","Clinical Performance Evaluation of MagIA In-vitro Diagnostic Medical Device for Multiplex Screening of Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C and Syphilis in Sub-Saharan Africa","MAGICS IBCS","Inclusion Criteria:\n\n* Provide informed consent for participation in this study.\n* Patient sample must meet at least one of the criteria below:\n\n  1\\. Positive samples (serum or plasma) from individuals who meet at least one of the following conditions:\n* HIV-1 Ab positive\n* HIV-2 Ab positive\n* HCV-Ab positive\n* HBsAg positive\n* Positive for at least TPHA, with those positive for both TPHA and VDRL ideally included 2. Negative samples (serum or plasma) from individuals who meet at least one of the following conditions:\n* Blood donors\n* Hospitalized patients or individuals coming to the clinic\n* Vulnerable populations (such as: drug users, prison population, ...) 3. Negative samples (serum or plasma) containing potential interfering substances from individuals who meet at least one of the following conditions:\n* Being a pregnant woman\n* Infected with at least one of the following viruses or bacteria: hepatitis A virus (HAV), hepatitis E virus (HEV), tuberculosis (TB), gonorrhoea, chlamydia, influenza virus, Covid-19\n* Presenting any of the following criteria:\n\n  * High IgG levels\n  * High rheumatoid factor (\\>15 IU\u002FmL)\n  * High cholesterol levels (\\>0.24 md\u002FdL)\n  * High bilirubin levels (\\>0.25 mg\u002FmL)\n  * High triglyceride levels (\\>500 mg\u002FdL)\n  * Diagnosis of cancer\n\nExclusion Criteria:\n\n* Samples from patients below 18 years of age",true,{"count":116,"type":20},2950,"Performance study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and Syphilis) from serum, plasma samples collected prospectively or retrospectively in Ivory Coast and Kenya.",[119,120,24,25,121,122],"Multiplex Testing of HIV, HBV, HCV and Syphilis","HIV","Syphilis","Point of Care Testing",[124,120,24,25,121,125],"point of care test","multiplex testing","2026-01-30",{"date":128,"type":39},"2026-02-02",{"date":130,"type":39},"2025-07-29",{"date":132,"type":20},"2026-04",{"name":134,"class":135},"MagIA Diagnostics","INDUSTRY",2,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":47},"100544753","rapid-t-cell-analysis-test-in-patients-with-chronic-hbv-and-hbvhdv-disease-100544753","NCT06372990","Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV\u002FHDV Disease","Development of a Rapid T-cell Analysis Test to Guide the Management of Patients With Chronic HBV and HBV\u002FHDV Disease","BDTc","Inclusion Criteria:\n\n* 18 years of age or older\n* ability to understand and sign the informed consent\n* chronic HBV infection or HBV-HDV co-infection defined by positivity of HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months\n\nExclusion Criteria:\n\n* Co-infection with other hepatotropic viruses (HCV, HIV)\n* Treatment with immunosuppressive\u002Fimmunomodulatory drugs\n* Other congenital and\u002For acquired immunodeficiency conditions",{"count":146,"type":20},300,"Prospective, non-pharmacological, single-center, non-profit observational study.\n\nThe study design allows longitudinal evaluation of the immune response during the natural history of the infection and\u002For treatment, correlating the data with the outcome of the disease and antiviral therapies, which will be collected as study variables from the source documents.\n\nThe study population will be patients suffering from chronic HBV infection with or without HBV-HDV co-infection followed at the Division of Gastroenterology and Hepatology of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico.\n\nThe present study is part of an international cooperation project between the Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy) and the Duke-NUS Medical School, Singapore, financed by a grant (project MAECI-2023-23683653) and divided into two specific Work Packages:\n\n* WP 1 Milan team (WP1.1 - Clinical and virological phenotyping of CHB and CHD patients; WP1.2 - Clinical evaluation of rapid HBV T cell test in CHB and CHD populations)\n* WP 2 Singapore team (WP2.1 - Applicability of the rapid T cell assay approach; WP 2.2 - Optimization of the rapid T cell assay protocol)\n\nThe primary objective of the study is to define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay.",[24,149],"HBV\u002FHDV","2026-01-13",{"date":152,"type":39},"2026-01-15",{"date":154,"type":39},"2024-04-15",{"date":156,"type":20},"2026-09-30",{"name":158,"class":46},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":177,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100567661","phase-1-phase-1b-open-label-study-of-tune-401-to-assess-safety-pk-and-pd-in-adults-with-chronic-hepatitis-b-100567661","NCT06671093","Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B","Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection","Inclusion Criteria:\n\n* M\u002FF, BMI ≥ 18.5 kg\u002Fm² at screening, age 18-75, inclusive\n* Diagnosed with Chronic Hepatitis B\n* On nucleos(t)ide analogue\n* HBeAg-negative or positive\n\nExclusion Criteria:\n\n* ALT\u002F AST ≥ 1.5 × upper limit of normal (ULN) and total bilirubin ≥ 1. 5 × ULN\n* Participants with any evidence or history of liver disease of non-HBV etiology\n* Other protocol defined Inclusion\u002FExclusion criteria may apply","75 Years",{"count":168,"type":20},36,"INTERVENTIONAL",[171],"PHASE1","This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Tune-401 in adult participants with Chronic Hepatitis B.",[174,175,176,24],"Chronic Hep B","Chronic Hepatitis b","Chronic Hepatitis",[178,179,180],"Tune-401","Tune-401-001","CHB","2026-01-02",{"date":183,"type":39},"2026-01-06",{"date":185,"type":39},"2024-11-29",{"date":187,"type":20},"2028-10-30",{"name":189,"class":135},"Tune Therapeutics, Inc.",3,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":198,"maxAge":55,"enrollmentInfo":199,"targetDuration":4,"studyType":169,"phases":201,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":47},"100610722","phase-4-prospective-cohort-study-on-peg-ifn--2b-in-improving-clinical-cure-rate-of-pediatric-patients-with-chronic-hepatitis-b-100610722","NCT07231276","Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients With Chronic Hepatitis B","Prospective Cohort Study on Pegylated Interferon Alfa-2b in Improving Clinical Cure Rate of Adolescent and Pediatric Patients With Chronic Hepatitis B Virus Infection","Inclusion Criteria:\n\n* Aged 3 years and above but under 18 years;\n* Positive for hepatitis B virus (HBV) DNA;\n* Positive for hepatitis B surface antigen (HBsAg) (above the lower limit of baseline detection or \\> 0.05 IU\u002Fml);\n* The subject and their guardian(s) understand the study and voluntarily sign the informed consent form (if the guardians are the subject's parents, both parents must sign jointly).\n\nExclusion Criteria:\n\n* Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV);\n* Having contraindications to pegylated interferon alfa-2b:\n\n  1. Decompensated hepatitis B cirrhosis;\n  2. Subjects with autoimmune liver disease, metabolic liver disease, alcoholic liver disease, malignant tumor, decompensated liver disease, or a history of organ transplantation;\n  3. Subjects with severe neurological or psychiatric diseases;\n  4. Subjects with severe thyroid dysfunction, antinuclear antibody hyperactivity, or other autoimmune diseases;\n  5. Subjects with diabetes mellitus with poor blood glucose control;\n  6. Subjects with retinal or fundus lesions;\n  7. Subjects with severe heart disease, coronary heart disease, or cerebrovascular disease;\n  8. Subjects with poorly controlled epilepsy;\n* Adolescent and pediatric subjects with severe renal dysfunction (e.g., creatinine \\> 1.5 × upper limit of normal \\[ULN\\]);\n* Subjects deemed unsuitable for enrollment by the investigator(s).","3 Years",{"count":200,"type":20},113,[202],"PHASE4","In this study, comparisons will be made between the treatment group (which will receive pegylated interferon alfa-2b treatment) and the observation group (which will receive no drug treatment or be treated with nucleos(t)ide analogs). The primary objectives are to address the following questions: compare the efficacy evaluation indicators (with clinical cure rate as the primary one) between the pegylated interferon alfa-2b treatment group and the observation group; assess whether pegylated interferon alfa-2b treatment improves the clinical cure rate in patients with chronic hepatitis B virus (HBV) infection aged 3 years and above but under 18 years (adolescents and children); and explore optimized antiviral treatment regimens for adolescents and children with chronic HBV infection. The secondary objectives are to address the following questions: compare the immune response characteristics between adolescents and children with chronic HBV infection who achieved functional cure after pegylated interferon alfa-2b treatment and those who did not; investigate the immune mechanism underlying the achievement of functional cure in adolescents and children with chronic HBV infection treated with pegylated interferon alfa-2b; and identify plasma markers associated with treatment efficacy for predicting therapeutic outcomes.",[24,205],"Chronic Hepatitis B Virus",[24,207],"chronic hepatitis B virus","NOT_YET_RECRUITING","2025-11-13",{"date":211,"type":39},"2025-11-17",{"date":213,"type":20},"2026-01-01",{"date":215,"type":20},"2028-10-01",{"name":217,"class":46},"Nanfang Hospital, Southern Medical University",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":225,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100593503","real-world-study-on-liver-cancer-risk-in-chronic-hepatitis-b-patients-with-family-history-of-liver-cancer-100593503","NCT07007286","Real-world Study on Liver Cancer Risk in Chronic Hepatitis B Patients With Family History of Liver Cancer","A Real-World Study on Reducing the Risk of Liver Cancer in Chronic Hepatitis B Patients With a Family History of HBV-Related Liver Cancer.","Inclusion Criteria:\n\n* (1) Chronic hepatitis B (CHB) patients with HBsAg positivity for over 6 months; (2) Family history of HBV-related hepatocellular carcinoma (HCC) (first- or second-degree relatives with HBV-related HCC); (3) Age ≥ 30 years, regardless of gender; (4) Based on real-world clinical practice, patients receiving nucleos(t)ide analogue (NA) therapy, such as Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide Fumarate (TAF), or Tenofovir Amibufenamide (TMF), or those receiving combination therapy with nucleos(t)ide analogues and PEG IFNα-2b; (5) Negative pregnancy test within 24 hours before the first dose (for women of childbearing potential); (6) Voluntary participation, with the ability to understand and sign the informed consent form.\n\nExclusion Criteria:\n\n* (1) Patients diagnosed with hepatocellular carcinoma (HCC) or malignancies in other organ systems prior to treatment; (2) Patients with contraindications to Peg IFN α-2b (refer to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition) for details); (3) Patients in the immune-tolerant phase of HBV infection; (4) Patients scheduled for or with a history of organ transplantation; (5) Patients with hypersensitivity to interferon or any contraindication listed in the drug's prescribing information; (6) Other conditions deemed unsuitable for enrollment by the investigator.","30 Years",{"count":227,"type":20},1500,"This study is a prospective, multicenter, real-world cohort study designed to compare the long-term outcomes of chronic hepatitis B patients with a family history of HBV-related hepatocellular carcinoma (HCC) who receive PEG IFNα-2b combined with nucleos(t)ide analogues or nucleos(t)ide monotherapy. The primary endpoint is the incidence rate of HCC, and secondary endpoints include the rate of HBsAg seroclearance, changes in liver fibrosis, and survival rates. The study will last for 5 years and enroll approximately 15,000 patients, aiming to provide evidence-based optimization for CHB treatment regimens.",[24,230],"HCC","2025-05-28",{"date":233,"type":39},"2025-06-05",{"date":235,"type":20},"2025-06",{"date":237,"type":20},"2032-12",{"name":239,"class":46},"Peking University First Hospital",555,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":248,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":252,"conditions":253,"keywords":254,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"100587304","a-real-world-study-of-antiviral-therapy-in-children-with-chronic-hepatitis-b-100587304","NCT06926647","A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B","A Multicenter, Prospective, Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B","Inclusion Criteria:\n\n* Initial Treatment Group:\n\n  1. The guardian understands and signs the informed consent form (both parents must sign), and adheres to the relevant requirements of this study. If the participant is 8 years old or older, they must also sign the informed consent form. For participants under 8 years old who can express consent, their consent must be clearly documented.\n  2. Age: ≥1 year and \\\u003C13 years, either sex;\n  3. Positive for HBsAg and\u002For HBV DNA for more than 6 months;\n  4. No prior antiviral treatment.\n* Treated Group:\n\n  1. The guardian understands and signs the informed consent form (both parents must sign), and adheres to the relevant requirements of this study. If the participant is 8 years old or older, they must also sign the informed consent form. For participants under 8 years old who can express consent, their consent must be clearly documented.\n  2. Age: ≥3 years and \\\u003C13 years, either sex;\n  3. Previously diagnosed with chronic hepatitis B and received antiviral treatment with NAs for more than 1 year and currently on treatment;\n  4. No history of IFNα use in the past 6 months;\n  5. Negative for HBV DNA;\n  6. HBsAg quantification \\\u003C10,000 IU\u002Fml (HBsAg can be negative in the drug discontinuation observation group);\n  7. The drug discontinuation observation group must also achieve negative HBV DNA and HBeAg seroconversion for at least 1 year (based on continuous results from three consecutive reviews), and HBsAg \\\u003C10,000 IU\u002Fml; NAs will be discontinued after enrollment.\n\nExclusion Criteria:\n\n* 1.In the interferon group, blood white blood cell count \\\u003C3.5×10\\^9\u002FL, or platelet count \\\u003C80×10\\^9\u002FL, or prothrombin activity \\\u003C60%, or total bilirubin \\>34μmol\u002FL, or serum albumin \\\u003C35g\u002FL, or serum creatinine \\>133μmol\u002FL; 2.Coexistence of other active infections; 3. Coexistence of other chronic liver diseases or active liver diseases, such as autoimmune liver disease, drug-induced liver injury, Wilson's disease, decompensated cirrhosis, liver cancer; 4. Coexistence of other severe systemic diseases or malignant tumors, etc.; 5. History of allergy to nucleoside analogues or interferon; 6. Subjects whom the investigator deems to have poor compliance, unable or unwilling to provide informed consent, or unable to adhere to the study requirements, or other conditions not suitable for participation in this study.","1 Year","13 Years",{"count":251,"type":20},2000,"This is a multicenter, prospective, real-world study. The study plans to include a total of 2000 patients who meet the inclusion and exclusion criteria, consisting of 1600 treatment-naive patients and 400 treatment-experienced patients. The effectiveness and safety of different treatment strategies will be evaluated in children aged 1-12 years with treatment-naive and treatment-experienced chronic hepatitis B (CHB) and chronic HBV infection.",[24,175],[255,256],"Nucleos(t)ide Analogues（NAs）","Interferon alpha（IFNα）","2025-04-28",{"date":259,"type":39},"2025-04-29",{"date":41,"type":20},{"date":262,"type":20},"2028-12-31",{"name":264,"class":46},"Beijing 302 Hospital",85,{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":273,"enrollmentInfo":274,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":276,"conditions":277,"keywords":278,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":290},"100573470","study-on-the-treatment-of-hepatitis-b-virushbv-infected-individuals-with-peginterferon--2b-combined-with-na-100573470","NCT06746701","Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.","Investigating the Clinical Cure Rate and the Risk Reduction of Hepatocellular Carcinoma in Chronic HBV Infected Individuals With a Family History of Liver Cancer Using PegIFN α-2b Combined With NA Treatment in a Real-world Study.","Inclusion Criteria:\n\n* Age18-65 years (inclusive of 18 and 65), no restriction on gender;\n* HBsAg positive history for at least 6 months;\n* Family history of liver cancer \\[including first-degree and second-degree relatives; first-degree relatives are parents, children, and siblings (same parents), while second-degree relatives are uncles, aunts, grandparents, and great-grandparents; a family history of liver cancer means that one or more first-degree or second-degree relatives have had liver cancer\\];\n* Planning to or already receiving treatment with Peginterferon alpha-2b in combination with nucleoside (acid) analogs, or receiving nucleoside (acid) analogs treatment alone;\n* Negative urine or serum pregnancy test within 24 hours before the first dose (for women of childbearing age);\n* Willing to receive treatment and sign an informed consent form.\n\nExclusion Criteria:\n\n* Allergy to interferon;\n* History of using telbivudine for antiviral treatment;\n* ALT(Alanine Aminotransferase) greater than 10 times the upper limit of normal, total bilirubin greater than 2 times the upper limit of normal;\n* Decompensated liver cirrhosis;\n* Neutrophil count \\\u003C 1.5 x 10\\^9\u002FL or platelet count \\\u003C 80 x 10\\^9\u002FL;\n* Presence of severe lesions in vital organs such as the cardiovascular, pulmonary, renal, brain, and fundus;\n* Those with autoimmune diseases, psychiatric disorders, poorly controlled diabetes, or thyroid dysfunction (hyperthyroidism or hypothyroidism);\n* Confirmed or suspected liver cancer or other malignant tumors;\n* Post-organ transplant or preparing for organ transplantation;\n* Currently using immunosuppressants;\n* Pregnant or planning to become pregnant within 2 years;\n* Alcohol or drug addicts;\n* HIV co-infection;\n* Other conditions deemed unsuitable for interferon use by the attending physician.","65 Years",{"count":275,"type":20},400,"This is a retrospective prospective, open-label, multicenter clinical study aiming to recruit 400 individuals with a family history of liver cancer to explore the clinical cure rate and the effectiveness, feasibility, and safety of PEGylated interferon α-2b combined with nucleos(t)ide analogues in treating chronic HBV carriers with a family history of liver cancer for reducing the risk of liver cancer occurrence. Patients will enrolled into Group A (Peg-IFNα-2b combined with NA treatment group) or Group B (NA monotherapy group) based on their medication choices. Each group is expected to enroll 200 patients, with all patients followed up to 240 weeks. The dosage, frequency, and duration of treatment with Peg-IFN α-2b and NA will be prescribed by the researchers according to clinical practice and standard treatment protocols.",[24],[279,280,24],"Peginterferon α-2b injection","Nucleotide Analogues","2024-12-17",{"date":283,"type":39},"2024-12-24",{"date":285,"type":39},"2023-05-25",{"date":287,"type":20},"2029-05-25",{"name":289,"class":46},"Xiangya Hospital of Central South University",4,{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":4},"100560604","current-situation-of-health-care-in-women-with-hbv-or-hcv-infection-100560604","NCT06579313","Current Situation of Health Care in Women With HBV or HCV Infection","Inclusion Criteria:\n\nHBV Cohort -\n\n* ≥18 years old\n* serum HBsAg positive for \\>6 months\n* Treatment naïve or,\n* Patients who had been previously treated for HBV but discontinued for at least 1 year before enrollment\n\nHCV Cohort -\n\n* ≥18 years old\n* HCV-Ab positive\n* HCV RNA positive\n* Treatment naïve or,\n* Patients who had been previously treated for HCV with a regimen containing interferon and not had a sustained virologic response.\n\nExclusion Criteria:\n\n* HBV\u002FHCV Co-infection\n* HIV\n* History of hepatic decompensation or hepatocellular carcinoma\n* Other carcinoma\n* Other severe liver disease\n* Severe Comorbidity like cardiovascular disease, diabetes etc.\n* Patients who had discontinued previous HCV treatment because of an adverse event.\n* Patients who had previously received any nucleotide analogue HCV NS5B inhibitor or any NS5A inhibitor\n* Patients who had discontinued previous HBV treatment because of an adverse event.",{"count":298,"type":20},2500,"A multicenter, retrospective study conducted in male and female population infected with HBV or HCV in east China. HCV part, study will enroll 500 HCV antibody positive and HCV RNA positive patients during 2020.7-2023.12 and then observe the characteristics, duration from diagnosis to treatment, treatment rate and sustained virologic response (SVR12) among eligible female and male patients. HBV part, study will enroll 2000 HBsAg positive patients during 2016.7-2019.12 and then observe the clinical characteristics, natural history, duration from diagnosis to treatment, treatment rate and adherence among eligible female and male patients.",[24,25],"2024-08-29",{"date":303,"type":39},"2024-08-30",{"date":305,"type":20},"2024-09-01",{"date":307,"type":20},"2025-07-31",{"name":309,"class":46},"Ruijin Hospital",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":248,"enrollmentInfo":316,"targetDuration":4,"studyType":169,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":47},"100554800","phase-4-antiviral-therapy-in-infants-with-hbv-infection-100554800","NCT06503796","Antiviral Therapy in Infants With HBV Infection","Inclusion Criteria:\n\n* a. Age ≤ 1 year;\n* b. HBsAg and HBV DNA positive;\n* c. ALT ≤ 5 times the upper limit of normal (ULN) and no pathologic jaundice (two consecutive tests with an interval of 2 weeks - 3 months).\n* d. Parents are willing to participate in the study and sign an informed consent form, for children without parents, all legal guardians of need to give informed consent.\n\nExclusion Criteria:\n\n* a. Combined viral infections such as HAV, HCV, HDV, HEV, HIV, EBV, CMV, etc;\n* b. Combination of other liver diseases, such as autoimmune hepatitis, drug-induced liver injury, Wilson's disease;\n* c. WBC \\\u003C9 × 10\\^9\u002FL, or PLT \\\u003C90 × 10\\^9\u002FL;\n* d. Combination of other systemic serious diseases or hereditary diseases, etc;\n* e. Other conditions deemed by the investigator to be unsuitable for participation in this study.",{"count":317,"type":20},60,[202],"This study was a multicenter, prospective randomized controlled clinical study. A total of 60 HBV-infected infants with ALT ≤5 times the upper limit of normal (ULN) and without pathological jaundice were enrolled and randomized 1:1 into two groups: the control group and the antiviral treatment group. HBV-infected infants in the treatment group were treated with LAM before the age of 1 year and then combined with regular interferon for 52 weeks if they were still positive for HBV DNA and\u002For HBsAg after reaching the age of 1 year. The control group was followed up synchronously. Follow-up was conducted every 3 months during the study period. The main efficacy evaluation indexes: HBsAg conversion (functional cure) rate, HBeAg conversion rate, HBeAg seroconversion rate, HBV DNA conversion rate, HBsAg seroconversion rate, and ALT reversion rate at the end of 12 months of treatment and at 2 years of age.",[24],"2024-07-21",{"date":323,"type":39},"2024-07-23",{"date":325,"type":20},"2024-08",{"date":327,"type":20},"2026-11",{"name":264,"class":46},{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":114,"sex":337,"minAge":4,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":169,"phases":340,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":136},"100512384","the-triple-elimination-model-of-mother-to-child-transmission-program-tri-mom-100512384","NCT05951751","The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM)","Integrated Antenatal Screening for HIV, Syphilis, and Hepatitis B Virus (HBV) in Pregnant Women in Burkina Faso and The Gambia","TRI-MOM","Inclusion Criteria:\n\n* Women attending a postnatal visit in one of the selected maternities (no maternal age limit)\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Unable to provide consent","FEMALE",{"count":339,"type":20},2800,[341],"NA","The TRI-MOM program aims to implement and evaluate a simplified (based on inexpensive rapid diagnostic tests), integrated (in governmental health facilities) and coordinated (between health care workers) strategy for the triple elimination of HIV, syphilis and HBV mother-to-child transmission (MTCT) in nine maternal and child health services, 5 in Burkina Faso and 5 in The Gambia.\n\nThe TRI-MOM program has two components:\n\n1. an \"intervention\" component consisting of a pilot study to reinforce the antenatal screening and prevention of MTCT (PMTCT) capacities for the 3 targeted infections through the implementation of a simplified, integrated and coordinated strategy of triple elimination of MTCT.\n2. an \"evaluation\" component which will assess the impact of the TRI-MOM strategy on PMTCT services, reduction of HBV MTCT and women empowerment.",[344,121,24],"Hiv",[346,347,120,29,121,348,349],"maternal health","child health","prevention and control","pregnancy","2024-06-17",{"date":352,"type":39},"2024-06-20",{"date":354,"type":39},"2024-03-18",{"date":356,"type":20},"2025-05",{"name":358,"class":359},"Institut de Recherche pour le Developpement","OTHER_GOV",{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":17,"minAge":368,"maxAge":56,"enrollmentInfo":369,"targetDuration":4,"studyType":169,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":4},"100461784","impact-of-hepatitis-b-immunoglobulins-in-patients-with-chronic-hepatitis-b-on-hepatocellular-carcinoma---a-proof-of-concept-study-100461784","NCT05293158","Impact of Hepatitis B Immunoglobulins in Patients With Chronic Hepatitis B on Hepatocellular Carcinoma - a Proof of Concept Study","Impact of Hepatitis B Immunoglobulins in Patients With Chronic Hepatitis B on Hepatocellular Carcinoma","HBIG","Inclusion Criteria:\n\n* Patients ≥ 19 years and ≤ 80 of age\n* HBsAg-positive HCC-patients scheduled for resection in ≥6 weeks or HBsAg-positive HCC- patients listed for LT\n* Ability of subjects to understand character and individual consequences of the clinical trial\n* Written informed consent must be available before enrolment in the trial\n\nExclusion Criteria:\n\n* Clinically significant illness (other than HBV) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment\n* No eligibility for resection \u002F LT\n* Concurrent any other malignancy\n* Co-infection with hepatitis C virus (defined as HCV RNA positive, HCV RNA-negative\u002Fanti-HCV-positive patients can be included) and\u002For human immunodeficiency virus (HIV)\n* Clinical hepatic decompensation\n* Allergy to HBIG\n* Pregnant, lactating patients","19 Years",{"count":370,"type":20},5,[341],"In the current literature, infection with the hepatitis B virus (HBV) is described as one of the main risk factors for the development of hepatocellular carcinoma (HCC).\n\nAccording to the current study situation, the Hepatitis B surface antigen (HBsAg) is considered as an important marker, since low levels and sero-clearance of HBsAg are both correlated with a lower risk of HCC development \u002F recurrence.Currently there is no treatment option available that efficiently targets HBsAg. Besides neutralizing infectious HBV virions, Hepatitis B immunoglobulins (HBIG) can directly bind and neutralize extracellular HBsAg\u002FSVPs, and even intracellular HBsAg targeting is reported. In addition, HBIGs can initiate effector-cell attack (via antibody-dependent cellular cytotoxicity, ADCC) towards infected hepatocytes.\n\nThe potential benefit of HBIGs in the HCC context is further underlined by recent evidence for the ability of HBIGs to reduce the viability, proliferation, and self-renewal of tumor-initiating cells (TICs) - isolated from HBV-HCC patients - accompanied by downregulation of stemness markers, e.g., OCT-4.According to the current study situation, the use of HBIGs significantly reduces the risk of HBV reinfection after transplantation and improves the results of liver transplantation in patients with chronic HBV infection. The potential benefit of treating HBV-HCC patients on the LTx (liver transplantation) waiting list with hepatitis B immunoglobulin is the possible stop or inhibition of tumor progression while waiting for an LTx. So far there is no clinical evidence of this.\n\nMechanistically, hepatitis B immunoglobulin could occur through neutralization of circulating HBsAg, which is an important driver of an immunosuppressive environment in HBV patients, and possibly through direct effects against HBV HCC tumor cells (through antibody-dependent cellular cytotoxicity, ADCC). Therefore, the idea behind preoperative HBIG administration before liver transplantation is to reduce the rate of patients in whom a transplantation would no longer have been possible due to tumor progression. Thus, due to tumor progression in HBV-positive HCC-patients there is a monthly drop-out from the waiting list of about 4%.\n\nThe basic idea behind the treatment of HBV-HCC patients before tumor resection with hepatitis B immunoglobulin is to potentially stop or positively influence tumor progression through the effects mentioned above, in the time between diagnosis and resection.\n\nZhou et al. (2015) have shown a connection between HBsAg levels and HCC relapses after resection, although the exact role of HBsAg is still unclear. In no case will the treatment postpone the time of tumor resection, as only patients are considered who, for clinical reasons, can expect a certain time until resection. The present proof of concept study aims to quantify HBsAg reduction due to preoperative administration of HBIGs in HBV-positive HCC-patients and serve as a template for future multicentre clinical trials.",[88,24],"2024-01-17",{"date":376,"type":39},"2024-01-18",{"date":378,"type":20},"2024-11",{"date":380,"type":20},"2026-06",{"name":382,"class":46},"Medical University of Graz",{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":389,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":402},"100513432","predictive-value-of-hbv-pgrna-on-long-term-outcomes-in-hepatitis-b-patients-treated-with-antiviral-therapy-100513432","NCT05965388","Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy","Inclusion Criteria:\n\n* CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-related histological changes within 1 year if HBsAg positive less than 6 months;\n* Age between 18-80 years, gender is not limited；\n* Patients with chronic hepatitis B who have been determined by clinicians to start, or have already taken the first-line treatment {including pegylated interferon \\[IFN\\] monotherapy, a potent nucleos(t)ide analogue \\[NA\\] monotherapy, two different potent NAs combination therapy, or NA plus IFN combination therapy;\n* Patient who reads and signs informed consent.\n\nExclusion Criteria:\n\n* Patients with malignancies other than hepatocellular carcinoma.",{"count":390,"type":20},5000,"The goal of this prospective, exploratory, non-intervention, multi-center, real-world study is to investigate the predictive value of HBV pgRNA in the occurrence of long-term outcomes under antiviral therapy in patients with chronic hepatitis B.\n\nParticipants will take the necessary clinical examination and blood draw during the patient's treatment and follow-up, and all the treatment is determined by clinicians.",[24,230],"2023-07-20",{"date":395,"type":39},"2023-07-28",{"date":397,"type":20},"2023-12-01",{"date":399,"type":20},"2029-02-01",{"name":401,"class":46},"Wen-hong Zhang",10,{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":166,"enrollmentInfo":411,"targetDuration":4,"studyType":169,"phases":413,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":208,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":47},"100485186","phase-2-nivolumabipilimumab-and-chemotherapy-combination-in-advanced-nsclc-patients-with-hiv-hbv-hcv-and-long-covid-syndrome-100485186","NCT05597800","Nivolumab\u002FIpilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Long Covid Syndrome","A Phase 2, Multicenter, Open Label, Clinical Trial Evaluating Safety and Activity of Nivolumab\u002FIpilimumab and Chemotherapy Combination in Advanced NSCLC Patients With HIV, HBV, HCV and Post-acute Sequelae of SARS-CoV2 Infection (PASC).","LUNGVIR","Inclusion Criteria:\n\n* Participants must have histologically confirmed diagnosis of metastatic or unresectable NSCLC;\n* No sensitizing EGFR, ALK, ROS1, BRAF and NTRK alterations;\n* Eastern Cooperative Oncology Group (ECOG) score 0-1 (physically able to carry out light housework or office work through to being fully active as they were before cancer);\n* No prior systemic anticancer therapy;\n* Tissue or Programmed death-ligand 1 (PD-L1) results available;\n* HIV-1 or HIV-2 chronic infection, defined as i) a positive HIV 1-2 western blot or other FDA\u002FCE approved HIV confirmatory test (regardless the results of the HIV 1-2 screening test used \\[2nd, 3rd, 4th generation tests, rapid tests or laboratory tests (i.e., ELISA, EIA, CLIA, etc.)\\], ii) the referring physician's written record that HIV infection was documented, with supporting information on the participant's relevant medical history and\u002For current antiretroviral treatment for HIV infection;\n* Only subjects with chronic or resolved HBV infections might be eligible. Chronic HBV infections is defined as: the persistence of HBsAg positivity for more than 6 months (regardless HBeAg result, HBV-DNA level and the presence of liver necroinflammation). Resolved HBV infection is defined by: the absence of liver inflammation (clinically and laboratory), HBsAg negativity and HBsAb (anti-HBs antibodies) and HBcAb (anti-HBc IgG) positive result;\n* Only subjects with resolved HCV infections might be eligible. Subjects with a newly diagnosed chronic HCV infection (defined as: positive HCV antibodies + detectable HCV-RNA) should be treated for HCV infection before enrollment. Acute HCV infection \\[defined as a positive HCV-RNA and i) a negative serological HCV assay (HCV-Ab) or ii) a positive serological HCV assay (HCV-Ab) with a negative test 6 months earlier\\] cannot be enrolled in the study.\n* Patients with past HCV infection, with no evidence of chronic infection (i.e., anti-HCV antibody positivity, HCV-RNA negativity) should be excluded;\n* Patients with confirmed Long Covid syndrome or PASC defined, as suggest by World Health Organization (WHO), as \"condition occurs in individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms and that last for at least 2 months and cannot be explained by an alternative diagnosis\". This condition must be present at enrollment;\n* Participants must have a nasopharyngeal swab positive for Sars-Cov2 within 12 months before enrolment;\n* Participants must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to first treatment;\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam; scans must have been performed within 4 weeks prior to registration.\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of study drug;\n* Ability to understand and to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) score ≥2;\n* Untreated symptomatic brain metastases or leptomeningeal metastases;\n* Another active concomitant malignancy;\n* Active, known or suspected, autoimmune disease;\n* Active HBV or HCV infection, presence of any infectious disease requiring specific treatment.\n* Active Sars-Cov2 infection.",{"count":412,"type":20},105,[414],"PHASE2","Study type: Phase 2 - Interventional Trial Number of patients to be enrolled: 105 Participating countries: Italy Study drugs: nivolumab and ipilimumab Cohort A: HBV and HCV patients Cohort B: HIV patients Cohort C: Long COVID syndrome The stratification factors are HBV\u002FHCV positive (cohort A), HIV positive (cohort B), patients with Long Covid syndrome (Cohort C), histology (squamous vs non-squamous histology), and gender (male vs female).",[417,120,24,25,418],"NSCLC Stage IV","Long COVID","2022-10-26",{"date":421,"type":39},"2022-10-28",{"date":423,"type":20},"2023-02-01",{"date":425,"type":20},"2027-03-30",{"name":427,"class":46},"Universita di Verona"]