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A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
Rochester, MN
The purpose of the study is to determine if overall mortality is affected one year after a hematopoietic stem cell transplant (HCT) in patients given a vaccine to prevent cytomegalovirus (CMV). Safety of ASP0113 in subjects undergoing allogeneic HCT will also be evaluated.
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Efficacy and Safety of Maribavir in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment
Rochester, MN
The purpose of this study is to determine if an investigational treatment (Maribavir) is safe and effective in treating transplant recipient patients with cytomegalovirus (CMV) infections that are refractory or resistant to treatment.
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A Study of the Use of Quantiferon CMV Blood Test to Find the Length of CMV Prevention in CMV Donor (+) / Recipient (-) Solid Organ Transplant Recipients
Rochester, MN
The overall aim of this study is to evaluate the clinical utility of the QuantiFERON-CMV test in solid organ transplant recipients on CMV prophylaxis to predict development of CMV disease after completion of prophylaxis. Our hypothesis is that in CMV D+/R- solid organ transplant recipients, the development of immunity as measured by a positive QuantiFERON CMV assay will predict a lower risk of CMV disease after prophylaxis is completed.
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A Study to Evaluate the Effectiveness of VERIS CMV Assay to Measure Cytomegalovirus (CMV) as an Aid for Monitoring the Response of the Virus to Therapy
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the VERIS CMV Assay as an aid in the management of anti-CMV treatment for solid organ transplant patients by showing that virus levels are in agreement with the observed clinical status.
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SURPASS: A Randomized, Double-Blind, Multicenter Study of the Efficacy, Safety, and Tolerability of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus (CMV) Disease in CMV Seropositive Kidney Transplant Recipients
Rochester, MN
The purpose of this study is to compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of CMV disease in kidney transplant recipients who are CMV seropositive pretransplant and received antilymphocyte induction therapy.
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Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in Liver Transplant Recipients
Rochester, MN
This is a study of two different approaches for the prevention of CMV disease in liver transplant recipients. The primary purpose is to determine if Preemptive therapy is the same or better than Prophylaxis therapy for the prevention of CMV disease in CMV seronegative recipients that receive a CMV positive liver transplant. Patients meeting study criteria and who have provided informed consent will be randomized within 10 days of transplant to receive in an open label design, either antiviral prophylaxis with valganciclovir 900 mg orally once daily for 100 days or preemptive therapy (weekly monitoring for asymptomatic CMV viremia by ...
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A Randomized, Double-Blind, Multicenter, Phase 3 Study of the Efficacy, Safety, and Tolerability of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease in CMV Seronegative Kidney Allograft Recipients
Rochester, MN
To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a kidney from a CMV seropositive donor.
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A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study will also evaluate the safety of ASP0113 in this patient population.
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A Study of the Quantiferon CMV Blood Test to Predict the Risk of CMV Returning After Treatment of the Disease in Solid Organ Transplant Recipients
Rochester, MN
The overall aim of this study is to determine whether solid organ transplant recipients who develop immunity to cytomegalovirus (CMV) after an initial episode of CMV disease as measured by the QuantiFERON-CMV assay are at lower risk of CMV recurrence in the future.
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Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients
Rochester, MN
The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.
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A Study to Evaluate NPC-21 to Treat Kidney Transplant Patients at High Risk for Cytomegalorvirus Infection
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the effectiveness and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.
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A Study to Evaluate Clinical Performance of the Aptima® CMV Quant Assay on the Panther® System
Rochester, MN
The purpose of this study is to evaluate the clinical performance of the Aptima CMV Quant assay on the Panther system in ethylenediaminetetraacetic acid (EDTA) plasma samples from solid organ transplantation recipients (SOTR) and hematopoietic stem cell transplant recipients (HSCTR).
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Study for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients
Rochester, MN
The purpose of this study is to compare the efficacy and safety of maribavir to valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell transplant recipients.
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The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
Albert Lea, MN; Mankato, MN
The purpose of this study is to determine whether a common virus, cytomegalovirus (CMV), may increase fatigue and other symptoms following treatment for ovarian cancer.