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A pivotal, multi-center, open-label, Phase III trial for Mangoral as a contrast agent in patients with focal liver lesions and severe renal impairment

Trial Profile

A pivotal, multi-center, open-label, Phase III trial for Mangoral as a contrast agent in patients with focal liver lesions and severe renal impairment

Planning
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2018

At a glance

  • Drugs CMC 001 (Primary)
  • Indications Liver cancer
  • Focus Diagnostic use; Registrational
  • Sponsors Ascelia Pharma
  • Most Recent Events

    • 07 Dec 2018 New trial record
    • 21 Nov 2018 According to an Ascelia Pharma media release, the design of this trial is based on the feedback from the U.S. FDA and will support regulatory approval. The company expects to enrol the first patient during the second half of 2019.
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