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Phase 3 pivotal study of BIV201 in the treatment of hepatorenal syndrome-acute kidney injury (HRS-AKI)

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Phase 3 pivotal study of BIV201 in the treatment of hepatorenal syndrome-acute kidney injury (HRS-AKI)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2021

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At a glance

  • Drugs Terlipressin (Primary)
  • Indications Ascites; Hepatorenal syndrome
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 01 Dec 2021 According to a BioVie media release, the company expects to initiate this trial in first half of 2022.
    • 29 Jun 2021 New trial record
    • 24 Jun 2021 According to a BioVie media release, the company recently announced FDA guidance for the design of this trial and expect to initiate this trial next year.

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