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A Phase 3, Open-label, Single-arm, Repeated-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)

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Trial Profile

A Phase 3, Open-label, Single-arm, Repeated-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2024

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At a glance

  • Drugs Maribavir (Primary)
  • Indications Cytomegalovirus infections
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Acronyms Protego
  • Sponsors Takeda; Takeda Development Center Americas

    • Most Recent Events

    • 06 Nov 2024 Status changed from recruiting to active, no longer recruiting.
    • 28 Aug 2024 Planned End Date changed from 22 Nov 2026 to 18 Jan 2027.
    • 28 Aug 2024 Planned primary completion date changed from 22 Nov 2026 to 18 Jan 2027.

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