A Phase 2, Randomized Study to Assess the Safety and Anti-cytomegalovirus (CMV) Activity of Different Doses of Maribavir for Treatment of CMV Infections That Are Resistant or Refractory to Treatment With Ganciclovir/Valganciclovir or Foscarnet in Transplant Recipients

Trial Profile

A Phase 2, Randomized Study to Assess the Safety and Anti-cytomegalovirus (CMV) Activity of Different Doses of Maribavir for Treatment of CMV Infections That Are Resistant or Refractory to Treatment With Ganciclovir/Valganciclovir or Foscarnet in Transplant Recipients

Completed
Phase of Trial: Phase II

Latest Information Update: 04 Jan 2018

At a glance

  • Drugs Maribavir (Primary)
  • Indications Cytomegalovirus infections
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Shire; Shire ViroPharma
  • Most Recent Events

    • 04 Jan 2018 According to a Shire Pharmaceuticals media release, based on the data from two Phase 2 studies the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for maribavir (SHP620) for treatment of cytomegalovirus (CMV) infection and disease in transplant patients resistant or refractory to prior therapy.
    • 03 May 2017 Results analysing the safety and efficacy presented at the 2017 American Transplant Congress.
    • 27 Oct 2016 Results published in the Shire Media Release.
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