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

Inclusion Criteria * Informed consent prior to any study-related procedures * Male or female patients age 18 to 75 years old * Cirrhosis of the liver (Non-alcoholic steatohepatitis, alcohol, viral and autoimmune) * Patient has diuretic-resistant, intractable ascites or is unsuitable for treatment with diuretics and required: o In the 60-day period from the last LVP before consent, required, between 3 and 9 LVPs, including the last LVP on or before the day of consent. * Dates for all LVPs that occurred within 90 days prior to consent have been recorded. The volume of ascites removed at each of the LVPs must also have been recorded for the 90-day period prior to the last LVPs before consent * Serum creatinine (SCr) ≤2.00 mg/dL determined prior to randomization * Women of child-bearing potential (e.g. not post-menopausal for at least one year or surgically sterile) must be neither pregnant nor lactating and must agree to use adequate birth control or be abstinent for the duration of the study * If patient is treated with ACE inhibitors or beta blockers, dose has been stable for at least 30 days prior to randomization and may be maintained on that dose for the trial duration * If patient is treated with diuretics, patient has been on a stable daily dose for at least 10 days prior to consent * Willing and able to comply with trial instructions Exclusion Criteria * Ascites with causes other than cirrhosis; such as cardiac or nephrogenic ascites or malignant ascites due to per…