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

Exclusion Criteria

• •Ascites with causes other than cirrhosis; such as cardiac or nephrogenic ascites or malignant ascites due to peritoneal carcinomatosis
• •Urinary sodium excretion \>100 mmol/day between day of consent and randomization
• •Total bilirubin \>5 mg/dL
• •Blood clotting International normalized ratio (INR) \>2.5
• •Current or recent (within 3 months of consent) renal replacement therapy
• •Current or recent (within 3 month of consent) hepatic encephalopathy Grade 3 or 4 (West-Haven)
• •Superimposed acute liver failure/injury due to factors including acute alcoholic hepatitis, acute viral hepatitis, drugs, medications (e.g., acetaminophen), or other toxins (e.g., mushroom \[Amanita\] poisoning)
• •History or presence of hepatic hydrothorax, known pulmonary hypertension and a history of hepatopulmonary syndrome
• •Current or recent treatment (within 7 days of randomization) with octreotide, midodrine, vasopressin, dopamine or other vasopressors
• •Current or recent (in the previous 60 days from consent) episode of respiratory failure requiring positive airway pressure (PAP) devices or intubation
• •Sepsis episode in the previous 28 days from consent
• •Episode of SBP within the 28 days prior to consent
• •Episode of gastrointestinal hemorrhage (non-variceal) within 28 days prior to consent
• •Episode of esophageal variceal bleed within one week prior to consent
• •Ongoing documented or suspected infection
• •Severe cardiovascular disease that is a contraindication to terlipressin therapy such as a history of myocardial infarction, angina pectoris, advanced arteriosclerosis, uncontrolled cardiac arrhythmia, severe coronary insufficiency or uncontrolled hypertension
• •Findings suggestive of severe organic renal disease (severe proteinuria/hematuria, or abnormal renal ultrasound suggestive of obstructive renal pathology)
• •Use of nephrotoxic drugs (e.g., aminoglycosides) in the 4 weeks before screening
• •Severe comorbidity that in the opinion of the Investigator would affect short-term prognosis and/or disallow safe participation in the trial (such as for example, severe anemia or pancytopenia, advanced progressive neoplasia such as hepatocellular carcinoma, unless eligible for transplant)
• •Patient who, in the judgment of the investigator, has been an excessive alcohol drinker in the past 12 weeks
• •Patient is in the opinion of the investigator, despite previous education on sodium restriction, anticipated to remain grossly non-compliant of sodium restricted diet
• •Implanted alfapump or previous recipient of alfapump that had pump removed within past 3 months
• •Recipient of renal or liver transplant
• •Planned elective surgery related to cirrhosis complications, for example for hernia repair
• •Known allergy or hypersensitivity to terlipressin
• •Participation in other clinical research studies involving the treatment with other investigational drugs or evaluation with implantable devices within 30 days of consent