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

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 any sedatives, benzodiazepines, or any neuro- or psycho-active drugs in the last 6 hours and a positive urinary drug screen
• •Congestive heart failure (New York Heart Association Class III or IV)
• •Seizures, dementia, or any neurologic or psychiatric condition within the last 72 hours that may interfere with the assessment of the mental state
• •Current diagnosis of major aspiration pneumonia or pulmonary edema accompanied by an oxygen saturation of ≤ 90% while breathing supplemental oxygen
• •Laboratory test abnormalities determined to be clinically significant by the investigator
• •Enrollment in another experimental (interventional) protocol within the last 30 days or 5 half-lives of the experimental drug, whichever s longer
• •Any medical condition, which in the opinion of the investigator would constitute a contraindication to enrollment in the study