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A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

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A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2023

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At a glance

  • Drugs Maribavir (Primary) ; Valganciclovir
  • Indications Cytomegalovirus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms AURORA
  • Sponsors Shire; Takeda; Takeda Development Center Americas

    • Most Recent Events

    • 30 Nov 2023 Results reporting safety and efficacy data at week 8 published in the Clinical Infectious Diseases
    • 19 Dec 2022 According to a Takeda Media Release, company is sharing the AURORA study results with relevant regulatory agencies and will continue to engage with them on a potential path forward for maribavir in asymptomatic first-episode post-transplant CMV infection.
    • 19 Dec 2022 According to a Takeda Media Release, Full data results will be submitted for publication in a peer-reviewed journal.

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