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A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients With Known or Suspected Focal Liver Lesions and Severe Renal Impairment

Trial Profile

A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients With Known or Suspected Focal Liver Lesions and Severe Renal Impairment

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Mar 2024

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At a glance

  • Drugs CMC 001 (Primary) ; Alanine; Colecalciferol; Manganese chloride
  • Indications Liver disorders; Renal impairment
  • Focus Diagnostic use; Registrational
  • Acronyms SPARKLE
  • Sponsors Ascelia Pharma
  • Most Recent Events

    • 09 Feb 2024 According to an Ascelia Pharma media release, company starts image reading phase and re-confirms Phase 3 SPARKLE results by May 2024.
    • 18 Aug 2023 According to an Ascelia Pharma media release, the company reported the need for a re-evaluation of the collected images from this study. Clarification that the images were not read and scored properly. Preparations for the re-evaluation are already underway, and we will communicate the timeline and financial implications for this mid-September.
    • 09 Aug 2023 According to an Ascelia Pharma media release, the company provides clarifications around the intra-reader variability in read-out of images in the SPARKLE study
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