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A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

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Trial Profile

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Dec 2023

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At a glance

  • Drugs Maribavir (Primary) ; Cidofovir; Foscarnet; Ganciclovir; Valganciclovir
  • Indications Cytomegalovirus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms SOLSTICE
  • Sponsors Shire; Takeda; ViroPharma Incorporated

    • Most Recent Events

    • 21 Dec 2023 According to a Takeda media release, based on results from this trial the LIVTENCITY (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.
    • 28 Jul 2023 Results (n=350) of a drug resistance analysis of maribavir therapy for refractory or resistant cytomegalovirus infection in transplant recipients published in the Journal of Infectious Diseases
    • 22 Jun 2023 According to a Takeda media release, the company announced the positive recommendation from the Institut national d'excellence en sante et en services sociaux (INESSS) for LIVTENCITY™ (maribavir) for public reimbursement in Quebec. The recommendation was based on the findings from this trial.
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