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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

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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Dec 2021

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At a glance

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

    • Most Recent Events

    • 23 Nov 2021 According to a Takeda - Pharm Research Associates (JV) media release, the U.S. Food and Drug Administration approved Livtencity (maribavir) for treating adults and pediatric patients (12 years of age and older and weighing at least 35 kilograms) with post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV.
    • 07 Oct 2021 According to a Takeda media release, the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of maribavir for the treatment of refractory CMV infection and disease with or without genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients based on the results of this Phase 2 and Phase 3 TAK-620-303 (SOLSTICE) trials.
    • 29 Jul 2020 Results assessing the viral mutations and associated drug resistance phenotypes detected at baseline and after maribavir therapy in patients enrolled in trials 202 and 203 published in the Journal of Infectious Diseases
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