| Valcyte (valganciclovir) / Roche, Mitsubishi Tanabe |
2007-003472-19: Determining a viral load threshold for pre-emptive therapy for cytomegalovirus infection in transplant patients using real time PCR monitoring. |
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| Ongoing | 4 | 178 | Europe | foscarnet, Ganciclovir, valganciclovir, Intravenous infusion, Powder for injection*, Film-coated tablet, Foscavir, Cymeve IV, Valcyte 450mg film-coated tablets | Royal Free Hampstead NHS Trust | Transplant recipients with CMV infection. | | | | |
2010-020551-31: Randomized study of oral ganciclovir versus i.v. ganciclovir for preemptive therapy of cytomegalovirus infection after stem cell transplantation. |
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| Ongoing | 4 | 100 | Europe | Valcyte, Cymevene, Valcyte, Cymevene, Valcyte, Cymevene | Nordic Bone and Marrow Transplantation Group | First cytomegalovirus DNAemia after stem cell transplantation | | | | |
2013-004445-17: STUDY FOR THE PREDICTION OF CYTOMEGALOVIRUS INFECTION IN RENAL TRANSPLANT PATIENTS BY THE EVALUATION OF THE IMMUNE RESPONSE BEFORE TRANSPLANTATION ESTUDIO PARA LA PREDICCIÓN DE LA INFECCION POR CITOMEGALOVIRUS EN PACIENTES TRANSPLANTADOS RENALES MEDIANTE LA EVALUACIÓN DE LA RESPUESTA INMUNE ANTES DEL TRANSPLANTE |
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| Ongoing | 4 | 160 | Europe | valcyte, CYMEVENE, VALCYTE, valcyte, CYMEVENE, VALCYTE | HOSPITAL UNIVERSITARI DE BELLVITGE, IDIBELL- INSTITUT D'INVESTIGACIÓ BIOMÈDICA DE BELLVITGE | cytomegalovirus infection in renal tranplant recipients Infección por citomegalovirus en receptores de un transplante renal | | | | |
2011-005708-13: Multicenter clinical trial comparing the efficacy and safety of two strategies in the prevention of cytomegalovirus infection in kidney transplant recipients. Ensayo clínico multicéntrico de comparación de la eficacia y seguridad de dos estrategias en la prevención de la infección por citomegalovirus en trasplantados renales. |
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| Ongoing | 4 | 354 | Europe | Valcyte 450 mg, Cymevene inyectable, Valcyte 450 mg comprimidos recubiertos con película, Cymevene inyectable, Valcyte 450 mg comprimidos recubiertos con película, Cymevene inyectable | Fundación para la Investigación Biomedica del Hospital 12 de Octubre, Instituto de Salud Carlos III | Prophylaxis of cytomegalovirus infection in seropositive kidney transplant recipients. Profilaxis de la infección por citomegalovirus en receptores seropositivos de trasplante renal. | | | | |
| Active, not recruiting | 4 | 92 | | | ass. Prof. Tomas Reischig, M.D., Ph.D., Project ED2.1.00/03.0076 from European Regional Development Fund., Charles University Research Fund (project number P36), Charles University Research Fund (Progres Q39) | Cytomegalovirus infection after renal transplantation | | | | |
2019-001032-54: Impact of anti-cytomegalovirus (valganciclovir) treatment in the management of relapsing ulcerative colitis (UC) requiring vedolizumab therapy: a randomized clinical trial comparing a strategy with or without antiviral therapy Impact du traitement anti-cytomégalovirus (valganciclovir) dans la prise en charge des poussées de rectocolite hémorragique (RCH) nécessitant un traitement par vedolizumab : étude thérapeutique randomisée comparant une stratégie avec ou sans antiviral |
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| Not yet recruiting | 4 | 120 | Europe | valganciclovir, vedolizumab, Coated tablet, Powder for suspension for injection, valganciclovir, vedolizumab | CHU de Saint Etienne, CHU de Saint Etienne | Patient with active ulcerative colitis who failed to anti-TNF with endoscopic active disease with an endoscopic Mayo score> 1 and 2 biopsies of the inflammatory tissue and presence of a CMV infection in the inflammatory tissue objectified by a viral load greater than 5 IU / 100000 cells by qPCR. Patient avec poussée inflammatoire de rectocolite hémorragique sous anti-TNF avec score Mayo endoscopique > 2 avec infection à CMV dans le tissu inflammatoire (charge virale supérieure à 5 UI/100000cellules), Patient with active ulcerative colitis who failed to anti-TNF with endoscopic active disease with an endoscopic Mayo score> 2 and presence of a CMV infection (inflammatory tissue = 5UI/100000cells) Patient avec poussée inflammatoire de rectocolite hémorragique sous anti-TNF avec score Mayo endo > 2 avec infection à CMV dans le tissu inflammatoire (charge virale supérieure à 5 UI/100000cell), Diseases [C] - Digestive System Diseases [C06] | | | | |
2019-002233-11: Multicenter clinical trial to evaluate the efficacy of a preventive strategy against CMV infection in heart transplant patients, based on T cells responses. Ensayo clínico multicéntrico para evaluar la eficacia de una estrategia preventiva contra la infección por CMV en pacientes con trasplante de corazón, basado en la respuesta basal específica de las células T. |
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| Ongoing | 4 | 188 | Europe | Valganciclovir, Ganciclovir, Capsule, Solution for solution for injection, Valganciclovir, Ganciclovir | Dr. José González Costello.Unidad de Insuficiencia cardíaca avanzada y Trasplante cardíaco. Hospital Univ. Bellvitge, Fondos de Investigación Sanitarias (FIS) INSTITUTO CARLOS III, Beca SEC: Proyecto de Investigación de trasplante cardíaco de la sección de insuficiencia cardíaca | We will investigate the benefits of monitoring the CMV-specific cellular response using the ELISPOT INF-y technique in patients with a positive serology against CMV, allowing the individualization of the preventión strategy. The drugs valganciclovir and ganciclovir will be used in seropositive patitens (IgG against CMV), not indicated in the data sheet but accepted as part of the habitual prophylaxis of heart transplant patient according to the clinical practice guidelines. Se investigarán los posibles beneficios de una monitorización de la respuesta celular CMV-específica mediante la técnica ElISPOT IFN-y en pac. con serología positiva frente al CMV,permitiendo individualizar el tipo de estrategia de prevención.Se harán uso de los fármacos valganciclovir y ganciclovir en pac. seropositivos (IgG positiva para CMV),no indicado en ficha técnica pero sí aceptado como parte de la profilaxis habitual de pac. trasplantados cardíacos según las guías de práctica habitual., To evaluate the efficacy of an individualized preventive strategy against cytomegalovirus infection in heart transplant patients Evaluar la eficacia de una estrategia preventiva e individualizada frente a la infección por Citomegalovirus en pacientes trasplantados cardíacos, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
ELISPOT-TC, NCT04278547: Multicenter Clinical Trial to Evaluate the Efficacy of a Preventive Strategy Against CMV Infection in Heart Transplant Patients, Based on the Specific T Cells Response |
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| Recruiting | 4 | 188 | Europe | ELISPOT IFN-γ assay, Valganciclovir | Hospital Universitari de Bellvitge, Instituto de Salud Carlos III, Sociedad Española de Cardiología | Heart Transplant Infection, CMV Infection | 03/22 | 03/23 | | |
ChiCTR2100044233: A multicentre clinical study on the diagnosis and treatment of sensorineural deafness caused by congenital cytomegalovirus infection |
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| Recruiting | 4 | 340 | | Ganciclovir injection 6mg/kg/ time, or valganciclovir oral 16mg/kg/ time, treatment course: 3 weeks BID + 1 week QD ;Ganciclovir injection 6mg/kg/ time, or valganciclovir oral 16mg/kg/ time, treatment course: 6 weeks BID ;Ganciclovir injection 6mg/kg/ time, or valganciclovir oral 16mg/kg/ time, treatment course: 6 weeks BID ;Ganciclovir injection 6mg/kg/ time, or valganciclovir oral 16mg/kg/ time, course of treatment: 4 months BID | Children's Hospital Affiliated to Zhejiang University Medical College; Children's Hospital Affiliated to Zhejiang University Medical College, National Clinical Medical Research Center | Congenital cytomegalovirus infection | | | | |
NCT06034925: Maribavir Vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients |
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| Active, not recruiting | 4 | 70 | US | Maribavir, Valganciclovir | Medical University of South Carolina, Takeda | Transplant Complication, CMV | 11/25 | 11/25 | | |
