[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cmv-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cmv-infection":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,57,90,115,148,177,206,227],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100644480","phase-1-evaluation-of-the-safety-and-efficacy-of-lb-dtk-mv-in-patients-diagnosed-with-antiviral-resistant-cmv-bkv-or-ebv-infection-or-associated-diseases-following-anticancer-therapy-or-allogeneic-hematopoietic-stem-cell-transplantation-100644480",false,"NCT07670468","Evaluation of the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.","A Single-Center, Open-Label, Phase 1\u002F2 Clinical Trial to Evaluate the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.","Inclusion Criteria:\n\n1. Patients aged 19 years or older who have undergone myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplantation using bone marrow, single or double umbilical cord blood, or peripheral blood stem cells (PBSCs). Or patients who have undergone any of the following anticancer treatments:\n\n   * CAR-T: Kymriah, Yescarta\n   * Bispecific Antibody: Glofitamab, Mosunetuzumab, Teclistamab, Elranatamab, etc\n2. Patients diagnosed with single or multiple, antiviral-resistant CMV, BKV, and\u002For EBV despite receiving standard treatment.\n3. Patients who are able to reduce their steroid dosage to 0.5mg\u002Fkg\u002Fday of Prednisolone (or an equivalent dose) or less.\n4. Patients with a hemoglobin level ≥8.0g\u002FdL.\n5. Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5x10\\^3\u002FμL or higher for 3 consecutive days following allogeneic hematopoietic stem cell transplantation.\n6. Patients with peripheral oxygen saturation (SpO2) ≥90% on room air.\n7. Patients who have at least one MHC class I HLA allele that matches the investigational product.\n8. For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.\n9. Female subjects or male subjects with female partners who agree to use the following contraceptive methods during the duration of this clinical trial and who meet the following criteria:\n\n   * Female participants or male participants with female partners who are postmenopausal (diagnosed with non-therapy-induced amenorrhea for 12 months or more or menopause)\n   * Female subjects or the female partners of male subjects who are surgically sterile (i.e., lacking ovaries and\u002For a uterus)\n   * Individuals who have agreed to strict abstinence during the clinical trial period \\[For female participants, intermittent abstinence (e.g., withdrawal during ovulation, the basal body temperature method, or withdrawal after ovulation) does not constitute agreement to abstinence\\]\n   * If the female subject or the female partner of a male subject is a woman of childbearing potential (WOCBP) who has not undergone sterilization, those who meet the following criteria:\n\n     * Hormonal contraceptives (implant, patch, oral)\n     * Intrauterine devices\n     * Dual barrier method (simultaneous use of the following two contraceptive methods: male condoms, female condoms, cervical caps, contraceptive diaphragms, contraceptive sponges)\n10. Individuals who have voluntarily decided to participate in this clinical trial and have provided written consent to comply with the restrictions.\n11. Individuals deemed suitable as trial subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).\n\nExclusion Criteria:\n\n1. Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the first dose.\n2. Individuals who meet any of the following criteria at the time of screening:\n\n   * Uncontrolled hypertension\n\n     * Systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite taking antihypertensive medication.\n   * Uncontrolled diabetes: Severe diabetes is defined as follows:\n\n     * Severe hyperglycemia with HbA1C ≥ 10.0%\n     * Individuals who have been hospitalized for diabetic ketoacidosis within the past 12 weeks.\n     * Individuals who have received emergency treatment or been hospitalized within the past 12 weeks for severe hypoglycemia (glucose \\\u003C54 mg\u002FdL) accompanied by seizures and loss of consciousness.\n   * Other viral infections \\[Ex. Human Immunodeficiency Virus(HIV), Hepatitis B Virus(HBV), Hepatitis C Virus(HCV)\\]. However, patients who are tested negative for HBsAg and positive for anti-HBcAb are not subject to this exclusion criterion.\n   * Tuberculosis\n   * Syphilis\n   * Moderate or severe liver damage \\[Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 5 times the upper limit of normal (ULN)\\]\n   * Chronic kidney disease \\[eGFR \\\u003C 30mL\u002Fmin\u002F1.73m\\^2\\]\n   * Patients with other uncontrolled infections. However, the following cases are considered controlled infections and do not meet the exclusion criteria:\n\n     * Bacterial infection. Patients must be undergoing definitive antibiotic treatment for the infection and must have shown no signs of progression of the infection for 72 hours prior to enrollment in this clinical trial.\n     * Fungal infection. The patient must be receiving systemic antifungal therapy and must have shown no signs of infection progression for 1 week prior to enrollment in this clinical trial.\n3. Patients who have undergone allogeneic hematopoietic stem cell transplantation within 28 days prior to the scheduled first dose, or who have received donor lymphocyte infusion (DLI) within 28 days prior to enrollment in this clinical trial.\n4. Patients with active acute graft-versus-host disease (GvHD) of grade 2 or higher.\n5. Patients requiring urgent anticancer therapy due to rapid tumor progression.\n6. Patients with a history of substance abuse within 24 weeks prior to administration of the investigational drug, or patients suspected of taking drugs of concern based on medical history and physical examination.\n7. Patients requiring vasopressors.\n8. Patients who have previously shown hypersensitivity to T-cell therapy.\n9. Patients with a history of autoimmune disease.\n10. Patients with hemophilia who are at risk of severe bleeding during administration, or patients receiving anticoagulants.\n11. Patients who have received another virus-specific T cell product within 28 days prior to administration of the investigational drug.\n12. Patients with a life expectancy of less than 24 hours at the time of the screening visit.\n13. Patients aged under 19.\n14. Patients deemed ineligible for participation in this clinical trial by the investigator.","ALL","19 Years",{"count":19,"type":20},27,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of Multi-Virus Specific T cells (LB-DTK-MV) to treat patients diagnosed with antiviral-resistant CMV, BKV, or EBV infection or associated diseases after anticancer therapy or allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are:\n\n* What is the maximum tolerated dose of LB-DTK-MV based on dose-limiting toxicity?\n* Does the number of CMV, BKV, or EBV virus viral load decrease within 7 or 14 days after the second infusion of LB-DTK-MV?\n* Do treatment emergent adverse events occur after the second infusion?\n\nParticipants will:\n\n* Receive a single intravenous infusion of LB-DTK-MV during the baseline visit (low dose: 1x10\\^7\u002Fm\\^2; high dose: 2x10\\^7\u002Fm\\^2).\n* Receive the second infusion of LB-DTK-MV intravenously at the same dose 14 days after the first infusion.\n* Attend weekly follow-up visits at the clinic for 6 months after the first dose.",[27,28,29],"BKV Infection","EBV Infection","CMV Infection",[31,32,33,34,35,36,37,38,39,40,41,42,43],"CMV","EBV","BKV","Multi-virus","CMV-associated diseases","EBV-associated diseases","BKV-associated diseases","Allogeneic Hematopoietic Stem Cell Transplantation","Virus-specific T cells","Infections","Virus Diseases","Antiviral-resistant infection","Anticancer therapy","RECRUITING","2026-06-19",{"date":47,"type":48},"2026-06-26","ACTUAL",{"date":50,"type":48},"2025-12-04",{"date":52,"type":20},"2027-06-04",{"name":54,"class":55},"LucasBio","INDUSTRY",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":56},"100298003","phase-1-antigen-specific-cytotoxic-t-cells-in-the-treatment-of-opportunistic-infections-100298003","NCT03159364","Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections","Phase I\u002FII Multicenter Trial of Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections","Inclusion Criteria:\n\nSubjects with or without hematopoietic stem cell transplantation \u002F organ transplant recipients need to meet the following conditions:\n\n* Evidence of CMV, EBV, ADV, BKV or known pathogen infection (viral DNA, immunohistochemical cytology positive); contraindications or invalid to anti-microbial drugs.\n* Subjects with virus DNA increased in the 2 consecutive peripheral blood samples (≥ 1000 genomic copies\u002Fml blood) at least 24 hours apart.\n* Initial hematopoietic reconstitution: neutrophils (ANC) ≥ 0.5x109 \u002F L, platelet (PLT) ≥ 20x109 \u002F L.\n* Patients with pahogen disease (organ\u002F tissue infiltration) symptoms, fever, diarrhea, or lymphadenopathy, regardless of the level of peripheral blood virus DNA, and confirmed by the presence of viral DNA or microbial antigens within body fluid or biopsy.\n* The subject \u002F guardian has signed a written consent form before any trial begins.\n\nProper renal and hepatic functions (ULN denotes \"upper limit of normal range\"):\n\n* Creatinine ≤ 2\\*ULN.\n* Bilirubin ≤ 2\\*ULN.\n* SGOT ≤ 3\\*ULN.\n* SGPT≤ 3\\*ULN.\n\nIf CTL is not from the patient's own, then the provider of CTLs needs to meet the following criteria:\n\n* Did not receive chemotherapy or radiotherapy within 4 weeks prior to blood collection, and did not take any steroids for the previous week, did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.\n* White blood cells ≥ 3,500 \u002F μl, lymphocytes ≥ 750 \u002F μl.\n* Obtain a signed informed consent from the patient and \u002F or the guardian or the donor of the BMT recipient.\n* Human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or tuberculosis (TB) test is negative.\n* Physical examination in line with the standard of healthy blood donors.\n\nExclusion Criteria:\n\n* Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), or HTLV (HTLV antibody positive).\n* GVHD (graft-versus-host disease) performance score at II-IV.\n* Subject is albumin-intolerant.\n* Subject with life expectancy less than 4 weeks.\n* Subject participated in other investigational somatic cell therapies within past 30 days.\n* Subject with positive pregnancy test result.","6 Months","80 Years",{"count":67,"type":20},100,[23,24],"Epstein Barr Virus (EBV) or Cytomegalovirus (CMV) infection results in significant morbidity and mortality in hematopoietic stem cell transplantation (HSCT) patients. HSCT patients often face opportunistic infections due to the immunosuppressive state during transplantation. Antimicrobial drugs are usually used for prophylactic purposes and for treatment after early detectable infections. Unfortunately, some patients develop resistance to such drug treatment. In addition to HSCT patient, immune compromised patient may also be victim to opportunistic infections. Many infections can be effectively managed by functional immune recovery. In this study, the safety and efficacy of microbial-specific cytotoxic T lymphocytes (CTLs) will be investigated.",[71,28,29,72,27,73,74],"Pathogen Infection","Adenovirus Infection","Fungus Infection","Tuberculosis",[76,77,78,79],"CTL","Virus CTL","Fungus CTL","TB CTL","2026-06-18",{"date":82,"type":48},"2026-06-22",{"date":84,"type":48},"2026-06-01",{"date":86,"type":20},"2030-12-31",{"name":88,"class":89},"Shenzhen Geno-Immune Medical Institute","OTHER",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":97,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100581659","phase-2-study-evaluating-the-efficacy-and-safety-of-artesunate-100581659","NCT06853184","Study Evaluating the Efficacy and Safety of Artesunate","Phase 2, Randomized, Open-label, Active Comparator, Dose-ranging Study Evaluating the Efficacy and Safety of Artesunate for Injection in Combination With Ganciclovir or Valganciclovir for the Treatment of Cytomegalovirus Infection in Solid Organ Transplant Recipients","Inclusion Criteria:\n\n* Be at least 18 years of age\n* Recipient of a solid organ transplant (kidney, lung, heart, or liver)\n* Have a documented CMV infection\n* Have CMV DNAemia\n* Require IV GCV or oral VGCV\n* Be washed out from any anti-CMV antiviral drugs\n* Have all the following results as part of screening laboratory assessments\n* Have life expectancy of ≥ 12 weeks\n* Be willing and have an understanding and ability to fully comply with the study\n* If female use birth control\n\nExclusion Criteria:\n\n* Have taken IV GCV or oral VGC daily for \\>8 days\n* Have refractory CMV infection or disease\n* Have CMV antiviral drug resistance\n* Have a known hypersensitivity to artesunate, GCV, or VGCV\n* Pregnant (or expecting to conceive) or nursing\n* Have severe liver disease\n* Require ongoing treatment with or an anticipated need for treatment with drugs with known interactions with artesunate or GCV\n* Taking any another investigational drug with anti-CMV activity","18 Years",{"count":99,"type":20},90,[24],"This study is a randomized, open-label, active comparator-controlled, dose-ranging trial of the efficacy and safety of IV artesunate in combination with IV GCV or oral VGCV and SOC treatment compared to GCV or VGCV monotherapy and SOC treatment in SOT recipients with clinically significant CMV infection.",[29],[104],"CMV infection","2026-05-18",{"date":107,"type":48},"2026-05-19",{"date":109,"type":48},"2025-08-01",{"date":111,"type":20},"2028-06-30",{"name":113,"class":55},"Amivas Inc.",4,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":97,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":56},"100636857","phase-4-letermovir-vs-valganciclovir-in-cmv-r-kidney-transplant-100636857","NCT07571135","Letermovir vs Valganciclovir in CMV R+ Kidney Transplant","Letermovir Versus Valganciclovir for 90 Days in CMV Seropositive Kidney Transplant Recipients: Results of a Single-center Experience.","Inclusion Criteria (both arms):\n\n* ≥18 years old\n* Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant\n\nInclusion Criteria (letermovir arm):\n\n* Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation\n* Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation\n\nExclusion Criteria (both arms):\n\n* Multiorgan organ transplant\n* Received previous solid organ transplant or HSCT\n* Unable to take oral medications\n* Uncontrolled infections at the time of enrollment\n* Hemodynamically unstable or on mechanical ventilation at the time of enrollment\n* Documented HBsAg or detectable HCV RNA 90 days prior to enrollment or HCV+ donor\n* Pregnant or breastfeeding or planning to be pregnant, breastfeeding or donating eggs during study period and 90 days post cessation\n* Received any anti-CMV drug treatment within 7 days prior to enrollment\n* Current user of recreational or illicit drugs or alcohol dependence\n* History of CMV disease prior to enrollment\n\nExclusion Criteria (letermovir arm):\n\n* Previously participated in a letermovir study or any other study with CMV investigational agents\n* On dialysis or plasmapheresis at the time of enrollment\n* Known or suspected hypersensitivity to active or inactive ingredients from letermovir or acyclovir formulations\n* Child-Pugh Class C severe hepatic insufficiency\n* Currently participating or has participated in a study with an unapproved compound of device within 28 days or 5 half-lives of this study\n* Contraindications per letermovir or acyclovir package insert: patients on pimozide, ergot alkaloids; or pitavastatin and simvastatin when co-administered with cyclosporine",{"count":123,"type":20},300,[125],"PHASE4","The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir (\"mini dose\"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant.\n\nThe main question the study wants to answer is:\n\n• Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant?\n\nThe study will also look at other important questions:\n\n* Is letermovir easier for patients to tolerate than valganciclovir?\n* How long does it take for a CMV infection to appear in each group?\n* Are there differences in \"breakthrough\" CMV infections between the two medications?\n* For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups",[29,31,128,129],"CMV Viremia","CMV Disease",[31,131,132,133,134,135,136],"Kidney Transplant","Letermovir","Moderate Risk","CMV Prophylaxis","Valganciclovir","Neutropenia","NOT_YET_RECRUITING","2026-05-06",{"date":140,"type":48},"2026-05-08",{"date":142,"type":20},"2026-05",{"date":144,"type":20},"2028-11",{"name":146,"class":147},"Elisabeth Kincaide","OTHER_GOV",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":97,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":114},"100636803","phase-4-horus-cytomegalovirus-open-proof-of-concept-exploratory-trial-100636803","NCT07570433","HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial","HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial (HORUS-COPE): An International Proof-of-concept Clinical Trial on Modulation of Immunosuppressive Regimen in Solid-organ Transplant Recipients With Cytomegalovirus Infection.","HORUS-COPE","Inclusion Criteria:\n\n* Clinically stable adult patients (aged 18 years or older) who have received a solid organ transplant (e.g., kidney, liver, heart, lung, pancreas) and developed clinically significant CMV infection as determined by positive CMV PCR.\n* On maintenance therapy of tacrolimus, MPA, +\u002F- steroids.\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Active acute graft rejection or significant graft dysfunction requiring modification of the current immunosuppressive regimen, in the opinion of the investigator.\n* Receipt of more than 72 hours of antiviral therapy for CMV infection prior to enrolment, before randomization, including valganciclovir and\u002For IV ganciclovir therapy\n* Known intolerance or hypersensitivity to mTOR inhibitors or to any component of the everolimus formulation.\n* Any medical condition that constitutes a contraindication to everolimus use, as judged by the investigator.\n* Additional exclusion criteria for French sites:\n\n  * Patient not affiliated to the French social security system\n  * Patient under legal protection (guardianship, curatorship).",{"count":67,"type":20},[125],"Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality following organ transplantation.\n\nCell-mediated immunity plays a crucial role in controlling CMV replication after transplantation. Immune monitoring involves the use of immune biomarkers to dynamically estimate the risk of CMV replication. This approach allows for the individualization of preventive and therapeutic strategies, improving patient outcomes.\n\nThe HORUS-COPE trial is designed to assess the effect of immune modulation on CMV replication kinetics and to explore the performance of a selected immune signature during antiviral therapy for CMV infection to stratify patients based on their risk of not responding to immune modulation.",[29],[161,31,162,163,164,165,166,167,168],"solid organ transplantation","cytomegalovirus","immunosuppression","everolimus","mTORi","MPA","infection","immune signature","2026-04-29",{"date":138,"type":48},{"date":172,"type":20},"2026-04",{"date":174,"type":20},"2028-03",{"name":176,"class":89},"Oriol Manuel",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":184,"sex":16,"minAge":97,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":187,"briefSummary":188,"conditions":189,"keywords":193,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100632433","phase-2-systemic-and-topical-antiviral-control-of-cytomegalovirus-anterior-uveitis-treatment-outcomes---trials-i-and-ii-100632433","NCT07513623","Systemic and Topical Antiviral Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes - Trials I and II","STACCATO I\u002FII","Inclusion Criteria:\n\nTrial I - Inclusion Criteria\n\n* Age at or above the age of majority at the time of enrollment (≥18 years of age in the United States; ≥20 years of age in Thailand and Taiwan)\n* Presenting with active anterior uveitis, defined as ≥1+ anterior chamber cell per -Standardization of Uveitis Nomenclature (SUN) Working Group criteria, in one or both eyes at the time of screening\n* Clinical features suggestive of a viral etiology for anterior uveitis, as determined by the treating study ophthalmologist, including but not limited to one or more of the following:\n* Unilateral hypertensive uveitis (elevated intraocular pressure in the setting of anterior chamber inflammation)\n* Coin-shaped or stellate keratic precipitates\n* Iris atrophy\n* Corneal endothelial changes consistent with CMV endotheliitis\n* Detection of cytomegalovirus (CMV) DNA by directed polymerase chain reaction (PCR) testing of aqueous humor obtained via anterior chamber paracentesis at the screening visit (Exam 0), as determined by local site PCR testing\n* Willingness and ability to provide written informed consent prior to enrollment and prior to any research-specific procedures\n* Willingness and ability to comply with study visit schedule, medication regimen, and study procedures for the duration of Trial I (21 days)\n* For participants of reproductive potential:\n* Female participants must agree to use at least one effective method of contraception during the study treatment period and for at least 30 days following the last dose of study medication\n* Male participants with female partners of reproductive potential must agree to use barrier contraception during the study treatment period and for at least 90 days following the last dose of study medication\n\nTrial II - Inclusion Criteria\n\nParticipants may enter Trial II via one of two pathways. All participants must meet the following general inclusion criteria:\n\n* Age at or above the age of majority (≥18 years of age in the United States; ≥20 years of age in Thailand and Taiwan)\n* Prior confirmed diagnosis of CMV anterior uveitis, established by positive PCR testing for CMV DNA in aqueous humor obtained via anterior chamber paracentesis during an active episode of anterior uveitis (uveitis flare). This confirmation may have been established either:\n* During participation in Trial I of the current study, or\n* Prior to enrollment directly into Trial II, in which case documentation of a prior positive aqueous CMV PCR result is required\n* Currently clinically inactive anterior uveitis, defined as ≤0.5+ anterior chamber cell per SUN criteria, sustained for a minimum of 2 weeks prior to enrollment into Trial II\n* Completion of a minimum 2-week washout period free from all antiviral therapy prior to randomization into Trial II\n* Willingness and ability to provide written informed consent for Trial II participation (a separate consent process from Trial I) prior to enrollment and prior to any Trial II-specific research procedures\n* Willingness and ability to comply with the Trial II visit schedule, medication regimen, and study procedures for the duration of the 12-month follow-up period\n* For participants of reproductive potential:\n* Female participants must agree to use at least one effective method of contraception during the study treatment period and for at least 30 days following the last dose of study medication\n* Male participants with female partners of reproductive potential must agree to use barrier contraception during the study treatment period and for at least 90 days following the last dose of study medication\n\nExclusion Criteria:\n\nTrial I - Exclusion Criteria\n\n* Inactive anterior uveitis (≤0.5+ anterior chamber cell per SUN criteria) at the time of screening or enrollment\n* Intermediate uveitis, posterior uveitis, or panuveitis as the primary diagnosis, with or without concurrent anterior segment involvement\n* Detection of herpes simplex virus (HSV) or varicella zoster virus (VZV) by directed PCR testing of aqueous humor obtained at the screening paracentesis, regardless of whether CMV is also detected\n* Receipt of any antiviral therapy (systemic or topical ophthalmic) within 14 days prior to the screening visit\n* Receipt of a periocular or intraocular corticosteroid injection within 8 weeks prior to the screening visit\n* Current use of systemic immunosuppressive therapy, including but not limited to systemic corticosteroids (at doses exceeding the equivalent of prednisone 10 mg\u002Fday), immunomodulatory agents (e.g., methotrexate, mycophenolate mofetil, azathioprine, cyclosporine), or biologic agents\n* Known immunocompromising condition, including but not limited to:\n* Human immunodeficiency virus (HIV) infection, regardless of CD4 count or viral load\n* Solid organ or hematopoietic stem cell transplant recipient\n* Active malignancy requiring chemotherapy or radiation therapy\n* Primary or acquired immunodeficiency disorder\n* Abnormal screening laboratory values, specifically:\n* Absolute neutrophil count (ANC) \\\u003C 500 cells\u002FµL\n* Platelet count \\\u003C 25,000\u002FµL\n* Hemoglobin \\\u003C 8 g\u002FdL\n* Serum creatinine \\> 2.5 mg\u002FdL or estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m²\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 times the upper limit of normal\n* Pregnancy or breastfeeding at the time of screening or enrollment. A negative pregnancy test is required for all female participants of reproductive potential prior to enrollment.\n* Known hypersensitivity or prior serious adverse reaction to ganciclovir, valganciclovir, acyclovir, or any component of the study medications\n* Recent or planned ocular surgery in the study eye within 30 days prior to enrollment or anticipated within the 21-day Trial I study period\n* Known autoimmune disease that could independently cause anterior uveitis (e.g., HLA-B27-associated uveitis, sarcoidosis, Behçet's disease, juvenile idiopathic arthritis-associated uveitis), unless CMV is confirmed as the causative agent by positive aqueous PCR and the treating ophthalmologist determines that CMV anterior uveitis is the primary diagnosis\n* Inability or unwillingness to comply with study visit schedule, medication regimen, or study procedures\n* Participation in another interventional clinical trial involving an investigational drug or device within 30 days prior to enrollment, or concurrent participation in another interventional clinical trial\n* Any medical, psychological, or social condition that, in the opinion of the principal investigator or site investigator, would compromise the participant's ability to safely participate in the study, adhere to the study protocol, or provide valid informed consent\n\nTrial II - Exclusion Criteria\n\n* Active anterior uveitis at the time of enrollment into Trial II, defined as ≥1+ anterior chamber cell per SUN criteria\n* Failure to achieve a minimum of 2 weeks of clinical inactivity (≤0.5+ anterior chamber cell) prior to enrollment into Trial II\n* Failure to complete a minimum 2-week washout period free from all antiviral therapy prior to randomization into Trial II\n* No documented prior PCR-confirmed diagnosis of CMV anterior uveitis in aqueous humor obtained during an active episode of inflammation (uveitis flare), either during Trial I participation or prior to direct Trial II enrollment\n* Receipt of any antiviral therapy within 14 days prior to the Trial II enrollment visit (i.e., the 2-week washout requirement has not been met)\n* Current use of systemic immunosuppressive therapy, including systemic corticosteroids at doses exceeding the equivalent of prednisone 10 mg\u002Fday, immunomodulatory agents, or biologic agents, at the time of Trial II enrollment\n* Known immunocompromising condition as defined in Trial I exclusion criterion 7 above\n* Abnormal laboratory values at the time of Trial II enrollment screening, using the same thresholds as defined in Trial I exclusion criterion 8 above\n* Pregnancy or breastfeeding at the time of Trial II enrollment. A negative pregnancy test is required for all female participants of reproductive potential prior to Trial II randomization.\n* Known hypersensitivity or prior serious adverse reaction to ganciclovir, valganciclovir, acyclovir, or any component of the study medications\n* Recent or planned ocular surgery in the study eye within 30 days prior to Trial II enrollment or anticipated within the first 3 months of the Trial II follow-up period Inability or unwillingness to comply with the Trial II visit schedule, medication regimen, or study procedures for the 12-month follow-up period\n* Participation in another interventional clinical trial involving an investigational drug or device concurrent with Trial II participation, or within 30 days prior to Trial II enrollment\n* Any medical, psychological, or social condition that, in the opinion of the principal investigator or site investigator, would compromise the participant's ability to safely participate in Trial II, adhere to the study protocol, or provide valid informed consent",true,{"count":186,"type":20},117,[24],"The goal of this clinical trial is to compare antiviral treatment strategies for cytomegalovirus (CMV) anterior uveitis - a viral infection causing inflammation inside the front of the eye - in immunocompetent adults aged 18 years and older. The main questions it aims to answer are:\n\nDoes oral valganciclovir reduce aqueous humor CMV viral load more effectively than topical ganciclovir 2% eye drops or placebo after 7 days of treatment (Trial I)? Does long-term suppressive antiviral therapy (oral valganciclovir or topical ganciclovir 2% eye drops) reduce the rate of CMV anterior uveitis recurrence over 12 months compared to placebo (Trial II)?\n\nResearchers will compare oral valganciclovir, topical ganciclovir 2% eye drops, and placebo to see if either antiviral treatment reduces viral load and controls eye inflammation more effectively in the short term, and whether long-term antiviral suppression can prevent the disease from coming back after the inflammation has been controlled.\n\nParticipants will:\n\n* Undergo anterior chamber paracentesis (removal of a small amount of fluid from the front of the eye) for PCR testing to confirm CMV as the cause of their eye inflammation before enrollment\n* Be randomly assigned to receive oral valganciclovir 900 mg twice daily, topical ganciclovir 2% eye drops six times daily, or placebo for 7 days (Trial I), in addition to standard steroid eye drops\n* Return for follow-up visits at Day 7 and Day 21 for eye examinations, laboratory blood tests, and a second anterior chamber paracentesis at Day 7 to measure viral load after treatment\n* If eye inflammation is controlled after Trial I, be offered enrollment into Trial II, where they will be randomly assigned to long-term suppressive oral valganciclovir, topical ganciclovir 2% eye drops, or placebo for 12 months, with follow-up visits approximately every 2 months and additional visits if inflammation returns",[190,191,192,29],"Cytomegalovirus (CMV)","Anterior Uveitis","Infectious Uveitis",[194,195],"Infectious uveitis","CMV anterior uveitis","2026-03-30",{"date":198,"type":48},"2026-04-07",{"date":200,"type":20},"2026-07-01",{"date":202,"type":20},"2032-10-31",{"name":204,"class":89},"University of California, San Francisco",6,{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":97,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":215,"phases":4,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":4},"100627043","reducing-post-letermovir-cmv-infection-efficacy-of-an-immune-reconstitution-based-scoring-system-to-guide-prophylaxis-duration-100627043","NCT07443501","Reducing Post-Letermovir CMV Infection: Efficacy of an Immune-Reconstitution-Based Scoring System to Guide Prophylaxis Duration","Evaluation of the Efficacy of a Cytomegalovirus-Specific Immune Reconstitution-Incorporated Scoring System in Guiding the Duration of Antiviral Prophylaxis to Reduce Cytomegalovirus Infection Following Letermovir Discontinuation","Inclusion Criteria:\n\n* (1) Recipients who meet either of the following conditions:\n\n  1. CMV IgG-positive recipients undergoing HLA-haploidentical hematopoietic stem cell transplantation (HSCT).\n  2. CMV IgG-negative recipients receiving a graft from a CMV IgG-positive donor, and who have received letermovir as CMV prophylaxis post-transplant without prior discontinuation.\n* (2) Plasma CMV-DNA level below the lower limit of detection (local threshold: 400 copies\u002FmL) within 5 days before enrollment.\n* (3) Age ≥ 18 years.\n* (4) Ability to provide written informed consent independently.\n* (5) Negative for HIV, HBV, and HCV.\n* (6) Written informed consent must be provided before initiation of any study procedure. Consent may be provided by the patient or a legally authorized representative if, in the investigator's judgment, obtaining consent directly from the patient is not in the patient's best medical interest.\n\nExclusion Criteria:\n\n* (1) Prior clinical diagnosis of CMV infection, CMV disease, or CMV viremia before enrollment;\n* (2) Received ganciclovir, valganciclovir, foscarnet, acyclovir (oral dose \\>3200 mg daily, or intravenous dose \\>25 mg\u002Fkg daily), valacyclovir (oral dose \\>3000 mg daily), or famciclovir (oral dose \\>1500 mg daily) within 7 days before enrollment;\n* (3) Received the following treatments within 30 days before enrollment: cidofovir, CMV hyperimmune globulin, any experimental anti-CMV therapy or biologics;\n* (4) Presence of uncontrolled infection, requirement for mechanical ventilation, or hemodynamic instability at enrollment;\n* (5) Suffering from mental illness or other conditions that prevent compliance with study treatment and monitoring requirements;\n* (6) Inability or unwillingness to sign the informed consent form;\n* (7) Other special circumstances deemed ineligible by the investigator.",{"count":214,"type":20},1114,"OBSERVATIONAL","With the increasing use of letermovir and considering that haploidentical hematopoietic stem cell transplantation (haplo-HSCT) predominates in China alongside a high CMV seroprevalence in the population, multiple domestic centers have reported cases of CMV infection after letermovir discontinuation. Currently, there is no clear definition for the high-risk population who may benefit from extended letermovir prophylaxis. This study aims to utilize CMV-specific immune reconstitution to identify high-risk individuals for CMV infection after letermovir cessation post-transplant, thereby guiding the timing of letermovir discontinuation and balancing the risks and safety associated with prolonged prophylaxis.",[29],"2026-02-27",{"date":220,"type":48},"2026-03-02",{"date":222,"type":20},"2026-03-14",{"date":224,"type":20},"2027-12-14",{"name":226,"class":89},"Institute of Hematology & Blood Diseases Hospital, China",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":235,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":21,"phases":238,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":253},"100426407","phase-3-multivirus-specific-t-cell-transfer-post-sct-vs-adv-cmv-and-ebv-infections-100426407","NCT04832607","Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections","Treatment of Chemo-refractory Viral Infections After Allogeneic Stem Cell Transplantation With Multispecific T Cells Against CMV, EBV and AdV: A Phase III, Prospective, Multicentre Clinical Trial","TRACE","Inclusion Criteria:\n\n1. Adult or paediatric patients (\\> 2 months of age) after allogeneic stem cell transplantation (SCT) (no time restrictions apply) suffering from new or reactivated CMV or EBV or AdV infection refractory to standard antiviral treatment for two weeks (defined as no decrease or insignificant decrease of less than 1log in viral load over two weeks) as confirmed by quantitative blood PCR analysis.\n2. Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection.\n3. Written informed consent given (patient or legal representative) prior to any study-related procedures.\n\nExclusion Criteria:\n\n1. Patient with acute GvHD \\> grade II or extensive chronic GvHD at the time of IMP transfer\n2. Patient receiving steroids (\\>1 mg\u002Fkg BW Prednisone equivalent) at Screening.\n3. Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP infusion until 8 weeks post IMP infusion. Prescheduled prophylactic DLI ≤3x105 T cells\u002Fkg BW in case of T-cell depleted HSCT is not considered an exclusion criterion.\n4. Patient with organ dysfunction or failure as determined by Karnofsky (patients \\>16 years) or Lansky (patients ≤16 years) score ≤30%\n5. Concomitant enrolment in another clinical trial interfering with the endpoints of this study\n6. Any medical condition which could compromise participation in the study according to the investigator's assessment\n7. Progression of underlying disease (disease that has led to the indication of HSCT, e.g. leukaemia) that will limit the life expectance below the duration of the study\n8. Second line or experimental antiviral treatment other than Ganciclovir\u002FValganciclovir, Foscarnet, Cidofovir and Rituximab until 8 weeks after IMP Infusion or prophylactic Treatment other than Aciclovir or Letermovir throughout the study except approved by sponsor\n9. Known HIV infection. In case patients do not have a negative HIV test performed within 6 months before enrolment in the study, HIV negativity has to be confirmed by a negative laboratory test.\n10. Female patient who is pregnant or breast-feeding. Female patient of child-bearing potential (i.e. post menarche and not surgically sterilized) or male patient of reproductive potential not willing to use an effective method of birth control from Screening until the last follow-up visit (FU6, Visit 8).\n\n    Note: Women of childbearing potential must have a negative serum pregnancy test at study entry ≤7 days before IMP administration on Day 0. Acceptable birth control methods are hormonal oral contraceptive ('pill'), contraceptive injection or patch, intrauterine pessar or the combination of two barrier methods. The combination of female and male condomes is NOT acceptable. If the male partner is sterilized, no further contraceptive is required. Women of post-menopausal status (no menses for 12 months without an alternative medical cause) are also not required to use contraceptives during the study.\n11. Known hypersensitivity to iron dextran\n12. Patients unwilling or unable to comply with the protocol or unable to give informed consent.","2 Months",{"count":237,"type":20},149,[239],"PHASE3","Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults.",[242,28,29,243],"AdV Infection","Stem Cell Transplant Complications","2025-07-15",{"date":246,"type":48},"2025-07-18",{"date":248,"type":48},"2019-08-27",{"date":250,"type":20},"2028-09",{"name":252,"class":89},"Tobias Feuchtinger",33]