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

Phase 2

Terminated

Brief Summary: This study evaluates the addition of BIV201 (terlipressin diacetate) as a continuous infusion in addition to standard of care (diuretics and therapeutic paracentesis) for reduction of ascites and complications in adult patients with refractory ascites secondary to decompensated cirrhosis

Detailed Description: Terlipressin has been shown to reduce portal hypertension, improve renal function and induce natriuresis in cirrhotic patients with ascites without hepatorenal syndrome (HRS). It is approved in Europe for the treatment of bleeding esophageal varices and HRS type 1 and is usually administered as an IV bolus starting at 1 mg every 6 h and increased to 2 mg every 6 h (maximum 8 mg/day depending on response).

This study will evaluate the use of terlipressin delivered by continuous infusion for two 28 day treatment cycles for reduction of ascites accumulation and complications in adult patients with refractory ascites secondary to decompensated cirrhosis. Continuous infusion allows for a significant reduction in the daily effective dose required for treatment and improved safety of terlipressin delivered as a low-dose continuous infusion could enable its use in the outpatient setting in the prolonged treatment of patients with refractory ascites.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
BIV201 plus Standard of Care	BIV201 continuous infusion	BIV201 continuous infusion - treatment for two 28 day cycles.

Primary Outcome Measures

Name	Time	Method
Incidence of complications, at least grade 2 severity	180 days following randomization	Incidence of complications, at least grade 2, during the 180 days following randomization

Secondary Outcome Measures

Name	Time	Method
Change in cumulative ascites	12 weeks	Change in cumulative ascites during the first 12 weeks following randomization versus the 12 weeks pre-treatment

Locations (10): Mayo Clinic Jacksonville
🇺🇸
Jacksonville, Florida, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Mercy Medical Center
🇺🇸
Baltimore, Maryland, United States
University of Miami
🇺🇸
Miami, Florida, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
UCLA
🇺🇸
Los Angeles, California, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Hunter Holmes McGuire Veterans Affairs Medical Center
🇺🇸
Richmond, Virginia, United States