Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy

Inclusion Criteria: * Male or female between the ages of 18 and 75 years * Signed written informed consent by subject's representative * Current diagnosis of chronic liver disease with cirrhosis * West Haven score of Grade 3 or 4 Hepatic Encephalopathy * Weight between 45 and 150 kg * Elevated venous ammonia concentration, defined as a value above the normal range at the local laboratory * Estimated creatinine clearance of \> 30 mL/min/1.73m², calculated using the Cockcroft-Gault formula, or serum creatinine \< 2.5 mg/dL \[Cockcroft-Gault formula: creatinine clearance = (140 - age) x weight in kg divided by (72 x serum creatinine in mg/dL); multiply result by 0.85 for females\] * Adequate urinary output of ≥ 30 mL/hour for the last 2 hours if estimated creatinine clearance is \< 50 mL/min/1.73 m² * Negative pregnancy test or documented sterilization procedure (tubal ligation or hysterectomy) or 5 years post-menopausal Exclusion Criteria: * Major gastrointestinal bleeding (hematemesis, melena, or hematochezia) requiring blood transfusion within the last 24 hours * Uncontrolled sepsis, as defined by hemodynamic instability requiring vasopressor agents (renal-dosed dopamine allowed) * Current diagnosis of acute hepatic failure * Alcohol ingestion during last 24 hours * Post liver transplant * Serum sodium \< 120 mEq/L * Serum potassium ≤ 3.5 mEq/L * Use of probenecid, valproate, penicillin or its derivatives, or corticosteroids (oral or IV) within the last 24 hours * Use of a…