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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

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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: Completed
Phase of Trial: Phase II

Latest Information Update: 26 Mar 2022

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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

  • 04 Dec 2020 Status changed from active, no longer recruiting to completed.
  • 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.

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