A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites

PHASE2TerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

June 17, 2021

Primary Completion Date

May 8, 2023

Study Completion Date

May 8, 2023

Conditions
AscitesDecompensated Cirrhosis
Interventions
DRUG

BIV201 continuous infusion

BIV201 continuous infusion with terlipressin for a total of two 28 day cycles. Initiate treatment at 3 mg per 24 hour period and titrate stepwise up to a maximum of 8 mg per 24 hour period based on tolerability and response.

Trial Locations (10)

19104

University of Pennsylvania, Philadelphia

21202

Mercy Medical Center, Baltimore

23249

Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond

29425

Medical University of South Carolina, Charleston

32224

Mayo Clinic Jacksonville, Jacksonville

33136

University of Miami, Miami

37212

Vanderbilt University Medical Center, Nashville

46202

Indiana University, Indianapolis

55905

Mayo Clinic, Rochester

90095

UCLA, Los Angeles

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BioVie Inc.

INDUSTRY