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A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial 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

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial 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

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Nov 2019

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At a glance

  • Drugs VCL CB01 (Primary)
  • Indications Cytomegalic inclusion disorders; Cytomegalovirus infections
  • Focus Therapeutic Use
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 09 May 2018 Results (n=149) assessing 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, were published in the American Journal of Transplantation.
    • 03 May 2017 Results presented at the 2017 American Transplant Congress.
    • 19 Sep 2016 Primary endpoint has not been met. (Incidence of first cytomegalovirus (CMV) viremia), as reported by Astellas Pharma and Vical Media Release.
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