[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epstein-barr-virus-ebv-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epstein-barr-virus-ebv-infection":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,70,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100576735","phase-1-a-phase-ib-study-of-vk-2019-in-patients-with-relapsed-or-refractory-ebv-diffuse-large-b-cell-lymphomas-dlbcl-100576735",false,"NCT06789159","A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL)","4.1 Inclusion Criteria\n\n1. Informed consent obtained prior to any protocol mandated assessment.\n2. Age ≥ 18 years.\n3. Patient must have relapsed or refractory EBV-positive DLBCL after a minimum of 2 prior regimens of systemic therapy.\n4. Patient must have exhausted all available standard of care treatment options that could potentially provide clinical benefit.\n5. Toxicities related to prior therapy must have returned to Grade 1 or less, or if chronic must be stable. Peripheral neuropathy must be Grade 2 or less\n6. Prior anti-cancer treatment must have been completed greater than 2 weeks prior to study day 1.\n7. Patients must have measurable disease, as defined by IWG 2007 criteria.\n8. ECOG performance status score of ≤2\n9. Adequate organ function as defined by the following criteria:\n\n   1. Absolute neutrophil count \\> 1,500\u002Fmicrol (stable off any growth factor within 1 week of study drug administration)\n   2. Hemoglobin \\> 9 g\u002FdL (transfusion to achieve this level is permitted)\n   3. Platelet count \\> 75,000\u002Fmicrol (transfusion to achieve this level is NOT permitted)\n   4. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN);\n   5. Total serum bilirubin ≤ 1.5 x ULN;\n   6. Creatinine clearance≥ 60 ml\u002Fmin as calculated per Cockcroft and Gault equation.\n   7. Urinary protein \\\u003C 2+ by dipstick. If dipstick ≥ 2+, then a 24-hour urine collection can be done, and the patient may enter only if urinary protein is \\\u003C 1 g\u002F24 hour;\n10. Sexually active patients will agree to utilize birth control method during the study and for 18 weeks after the study is concluded, using effective birth control methods as defined in https:\u002F\u002Fwww.cdc.gov\u002Freproductivehealth\u002Funintendedpregnancy\u002Fpdf\u002Fcontraceptive\\_methods\\_508.pdf. See Protocol Appendix C.\n11. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.\n\n4.2 Exclusion Criteria\n\n1. Patients with severe or active symptomatic cardiopulmonary diseases (unstable angina and\u002For congestive heart failure or peripheral vascular disease within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders; patents with effectively treated conditions (e.g. stenting for CAD) are eligible.\n2. Patients with metastatic disease with active central nervous system (CNS) involvement, defined as parenchymal brain or leptomeningeal involvement.\n3. Concurrent administration of herbal preparations.\n4. A serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy.\n5. Patients currently taking drugs that inhibit or induce OATP1B1 or OATP1B3 within 5 half- lives of that agent. Examples are included in Appendix B.\n6. Patients currently taking drugs that are proton pump inhibitors (PPIs) within 5 half- lives of that agent. Examples are included in Appendix B.\n7. Patients who have received a prior organ allograft or allogeneic bone marrow transplant are eligible but must have no evidence of active GVHD and be off immunosuppressive drugs.\n8. Current non-prescription drug or alcohol dependence;\n9. For all female patients, pregnancy or breastfeeding.\n10. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment.\n11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study.\n12. Patients with corrected QT by Fridericia's formula (QTcF) of \\>470 ms are excluded.\n13. Patients with Post-Transplant Lymphoproliferative Disease (PTLD) are excluded.","ALL","18 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This is a Phase Ib in adult patients with relapsed or refractory EBV-positive DLBCL using daily oral dosing of VK-2019 in three dose escalation cohorts: 600 mg\u002Fday, 1200 mg\u002Fday, 1800 mg\u002Fday for 28 days (cycle), until progression or toxicity.",[25,26,27],"Diffuse Large B Cell Lymphoma Refractory","Diffuse Large B Cell Lymphoma Relapsed","Epstein-Barr Virus (EBV) Infection","RECRUITING","2026-06-24",{"date":31,"type":32},"2026-06-25","ACTUAL",{"date":34,"type":19},"2026-06",{"date":36,"type":19},"2028-10-01",{"name":38,"class":39},"Pierluigi Porcu","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100640821","phase-1-rituximab-for-ptld-prevention-in-solid-organ-transplant-recipients-with-ebv-dnaemia-100640821","NCT07614282","Rituximab for PTLD Prevention in Solid Organ Transplant Recipients With EBV DNAemia","A Phase 1 Trial of Rituximab in Addition to Standard of Care for the Prevention of Post-Transplant Lymphoproliferative Disorder in Solid Organ Transplant Recipients With EBV DNAemia","Inclusion Criteria:\n\n1. Patients must have received a solid organ transplant.\n2. Patients must not have a diagnosis of PTLD (confirmed with CT or PET imaging, and if there are concerning lesions present on imaging - a biopsy must be performed to rule out PTLD), or history of PTLD\n3. Age ≥ 18\n4. Patients must have EBV DNAemia ≥ 1000 IU\u002FmL (plasma) on two consecutive measurements at least 1 week apart and within a 6-week period. The second measurement must be within 4 weeks of enrollment.\n5. Patients must have had reduction in their immunosuppression according to institutional best practices prior to enrollment OR have documented clinical rationale for which immunosuppression may not be safely reduced (e.g. due to organ transplant rejection)\n6. Patients with a positive hepatitis B virus (HBV) core antibody and negative HBV surface antigen consistent with prior HBV exposure must be to take appropriate anti-viral prophylaxis. Patients with evidence of chronic HBV infection must have undetectable HBV viral load on the most recent test results obtained within the last year and received suppressive therapy.\n7. Participants with a history of hepatitis C virus (HCV) infection must have an undetectable viral load. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 28 days prior to consent.\n8. Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test (must be within 28 days prior to registration). Participants with known HIV must have a CD4 count checked within 28 days prior to registration, but may proceed with therapy regardless of CD4 count.\n9. Ability to understand and the willingness to sign a written informed consent document. If an individual lacks capacity, a legally acceptable surrogate\u002Flegally authorized representative should be able to understand and willing to sign a written informed consent document.\n10. Must have a life expectancy \\> 6 months\n11. Must not have an active malignancy unless in remission and with life expectancy \\> 2 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin or carcinoma \"in situ\" of the cervix or breast who are eligible even if diagnosed within 2 years. If patients have another malignancy that was treated within the last 2 years, such patients may be enrolled, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at CUIMC, and after consultation with the Principal Investigator. Hormone therapy for treated prostate and breast cancer is allowed.\n\nExclusion criteria:\n\n\\- Under the age of 18 years",{"count":49,"type":19},28,[22],"People who have received a solid organ transplant can develop ongoing Epstein-Barr virus (EBV) infection in the blood, which increases the risk of a serious cancer called post-transplant lymphoproliferative disorder (PTLD). This study will test whether rituximab, a drug approved by the U.S. Food and Drug Administration (FDA) for several immune-related conditions, can safely clear EBV from the blood and help prevent PTLD when lowering immune-suppressing medications is not possible or effective. The study includes an initial smaller group focused on determining whether EBV can be cleared, followed by a larger group designed to determine whether treatment lowers the risk of developing PTLD. Researchers will also monitor side effects, transplant organ health, and immune system changes to better understand treatment safety and benefit.",[53,54,55],"PTLD","Epstein Barr Virus (EBV) Infection","Solid Organ Transplant",[57,55,58,59],"PTLD Prevention","Rituximab","Epstein Barr Virus (EBV)","NOT_YET_RECRUITING","2026-05-22",{"date":63,"type":32},"2026-05-29",{"date":65,"type":19},"2026-07",{"date":67,"type":19},"2028-07",{"name":69,"class":39},"Jennifer Amengual",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":15,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":20,"phases":80,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100603227","phase-1-application-of-pd-1-inhibitors-combined-with-tenofovir-chidamide-and-lenalidomide-in-the-treatment-of-ebv-associated-diseases-100603227","NCT07133776","Application of PD-1 Inhibitors Combined With Tenofovir, Chidamide and Lenalidomide in the Treatment of EBV-associated Diseases.","A Multicenter, Single-Arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of EBV-Associated Diseases","Inclusion Criteria:\n\n1. Diagnosed with EBV infectious diseases, including infectious mononucleosis, chronic active EBV infection, or other EBV infectious diseases;\n2. EBV DNA ≥ 10⁴ copies\u002FmL in whole blood or plasma;\n3. Age ≤ 75 years with ECOG performance status ≤ 2;\n4. Estimated life expectancy over 3 months;\n5. Patients must be able to undergo follow-up. They should understand the nature of their disease and voluntarily agree to participate in this study for treatment and follow-up.\n\nExclusion Criteria:\n\n1. Patients with impaired liver or kidney function, specifically defined as serum direct bilirubin, indirect bilirubin, and\u002For ALT, AST, or serum creatinine \\>2 times the upper limit of normal (ULN), unless such abnormalities are attributed to lymphoma;\n2. Patients with bone marrow failure, defined as absolute neutrophil count (ANC) \\\u003C1.5×10⁹\u002FL or platelets \\\u003C75×10⁹\u002FL;\n3. Patients who have experienced grade III or higher neurotoxicity within the past 2 weeks;\n4. Patients with chronic heart failure classified as NYHA class III or IV, or left ventricular ejection fraction (LVEF) \\\u003C50%, or those with a history of the following cardiac events within the past 6 months: acute coronary syndrome, acute heart failure (NYHA class III or IV), or significant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, or resuscitated sudden cardiac arrest);\n5. Patients with AIDS, syphilis, or active hepatitis B (HBV DNA \\>1×10⁴ copies\u002FmL) or hepatitis C infection;\n6. Patients with coexisting hematologic disorders (e.g., hemophilia, myelofibrosis) deemed unsuitable for inclusion by the investigator;\n7. Patients with severe concurrent infections;\n8. Patients who have undergone grade II or higher surgery within 3 weeks prior to treatment;\n9. Patients with substance abuse, medical, psychological, or social conditions that may interfere with study participation or the evaluation of study outcomes;\n10. Patients deemed unsuitable for enrollment by the investigator;\n11. Patients with known hypersensitivity to components of the investigational drug.","0 Years","75 Years",{"count":18,"type":19},[22,81],"PHASE2","Currently, treatment options for Epstein-Barr virus (EBV) infection are limited, with unsatisfactory efficacy and no established standard therapy. Therefore, our center is conducting a prospective, multicenter, single-arm clinical trial to evaluate the efficacy and safety of PD-1 inhibitor in combination with tenofovir, chidamide, and lenalidomide in patients with EBV infectious diseases, aiming to provide a more effective and safer therapeutic option for EBV infectious diseases.",[27,84,85,86,87],"PD-1 Inhibitor","Tenofovir","Chidamide","Lenalidomide",[89,84,90,86,91],"Epstein-Barr Virus (EBV) infection","tenofovir","lenalidomide","2025-08-14",{"date":94,"type":32},"2025-08-21",{"date":96,"type":19},"2025-09-01",{"date":98,"type":19},"2027-09-01",{"name":100,"class":39},"The Affiliated Hospital of Xuzhou Medical University",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":40},"100449092","occurrence-of-antibodies-cross-reacting-with-autoantigens-in-primary-ebv-infection-100449092","NCT05127980","Occurrence of Antibodies Cross-reacting With Autoantigens in Primary EBV Infection","Occurrence of Antibodies Cross-reacting With Autoantigens in Primary EBV Infection - a Longitudinal, Observational Study","Inclusion Criteria:\n\nParticipants fulfilling all of the following inclusion criteria are eligible for the infectious mononucleosis (IM) group:\n\n* Informed consent as documented by signature\n* Confirmed primary EBV infection as confirmed by the treating clinician and defined by:\n* Compatible clinical (infectious mononucleosis symptoms including but not limited to malaise, headache, fever, tonsillitis, pharyngitis, cervical lymph nodes enlargement) and laboratory picture (lymphocyte count elevation, LUC cells, reactive lymphocytes in manual differential, elevated liver enzymes; of note, not all typically described features have to be fulfilled)\n\nAND\n\n* serology compatible with primary EBV infection (anti-EBNA IgG negative, anti-VCA IgG negative, anti-VCA IgM positive OR anti-EBNA IgG negative, anti-VCA IgG positive, anti- VCA IgM positive).\n\nParticipants fulfilling all of the following inclusion criteria will be eligible for the control group:\n\n* Informed consent as documented by signature.\n* one of the following:\n\n  1. Clinical picture of upper respiratory tract infection (including but not limited to tonsillitis\u002Fpharyngitis, malaise, headache, cough, rhinitis, cervical node enlargement)\n  2. confirmed primary Cytomegalovirus (CMV) infection (an optimal control group; however, the number of patients with a diagnosis of primary CMV infection is limited).\n\nExclusion Criteria:\n\n* Suspicion\u002Fdiagnosis of IM as per judgement of the treating clinician (control group only); this individual may be eligible later for the IM group if primary EBV infection is confirmed, subsequently.\n* Immunosuppression (broadly defined as primary\u002Fsecondary immunodeficiency or treatment with an immunosuppressive medication including ≥ 10mg prednisone equivalent).\n* History of autoimmune disease (e.g. SLE, vasculitis etc.)",{"count":109,"type":19},80,"OBSERVATIONAL","The aim of this study is to assess the occurrence of antibodies cross-reacting with autoantigens that have been detected in the context of SLE in patients with primary EBV infection over time compared to a control group. It is to establish a biobank of patients with primary EBV infection allowing to longitudinally analyze the immune response and its accompanying inflammatory processes with focus on the occurrence of antibodies cross-reacting with autoantigens associated with SLE and other autoimmune diseases.\n\nSubstudies will analyze\n\n* characteristics of primary EBV infection patients treated with antibiotics in comparison to patients treated without antibiotics and outcomes of these treatment regimens (occurrence of acute complications such as peritonsillar abscess (PTA) or need for tonsillectomy, frequency of fatigue or symptoms associated with chronic fatigue syndrome).\n* Procalcitonin (PCT) concentrations in primary EBV infection compared to control patients with similar symptoms and its association with disease severity and local complications.\n* the occurrence of fatigue and symptoms associated with chronic fatigue syndrome 6 and 12 months after primary EBV infection.",[27],[114,115,116,117,118,119,120],"Infectious mononucleosis (IM)","Viral capsid antigen (VCA)","EBV nucleic antigen (EBNA)","Systemic lupus erythematosus (SLE)","Chronic fatigue syndrome (CFS)","cross-reacting antibodies","molecular mimicry","2025-02-24",{"date":123,"type":32},"2025-02-25",{"date":125,"type":32},"2021-10-15",{"date":127,"type":19},"2026-12",{"name":129,"class":39},"University Hospital, Basel, Switzerland"]