Trial Profile
A study of BIV-201 for the treatment of ascites due to liver cirrhosis.
Status:
Planning
Phase of Trial:
Phase I
Latest Information Update: 23 Feb 2017
Price :
$35
*
At a glance
- Drugs Terlipressin (Primary)
- Indications Ascites
- Focus Adverse reactions
- 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).