A study of BIV-201 for the treatment of ascites due to liver cirrhosis.

Trial Profile

A study of BIV-201 for the treatment of ascites due to liver cirrhosis.

Planning
Phase of Trial: Phase I

Latest Information Update: 22 Feb 2017

At a glance

  • Drugs Terlipressin (Primary)
  • Indications Ascites
  • Focus Adverse reactions
  • Most Recent Events

    • 22 Feb 2017 According to a BioVie Inc. media release, the company expects to initiate this trial in the first half of 2017 after approval of IND by the US FDA.
    • 22 Feb 2017 According to a BioVie Inc. media release, the company has submitted a complete response to the US FDA addressing the issues identified in the IND clinical hold letter received by the company in January 2017.
    • 29 Nov 2016 According to a BioVie Inc media release, company announced the submission of an Investigational New Drug (IND) application for new drug candidate BIV201 to the US Food and Drug Administration (FDA).
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