A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy

Inclusion Criteria: * Subjects aged 18 and over * Clinical diagnosis of cirrhosis of any cause * Potential to benefit from HE treatment * History of greater than or equal to 2 documented episodes of WH Grade 2 or more HE within the past 6 months, at least one of which occurred within the preceding 3 months * No change in other HE-specific medications within 1 week before randomization * Able to give informed consent and comply with study activities * Availability of at least one designated family member or caregiver who is capable of and willing to assume responsibility for facilitating subject compliance with study procedures * All females of childbearing age and all sexually active males must agree to use an acceptable method of contraception throughout the study. Exclusion Criteria: * Use of any investigational drug within 30 days * Use of prohibited medications * Uncontrolled infection * Active GI bleeding or a history of GI bleeding requiring blood transfusion (\> 2 units) within 3 months * Transjugular intrahepatic portosystemic shunt (TIPS) placement or revision within the past 90 days * Recreational drug use or alcohol consumption for subjects with a history of alcohol or drug abuse within 6 months * Lactating and/or pregnant females * Active malignancy * Clinically significant bowel disease, including obstruction, inflammatory bowel disease, or malabsorption * Expected to undergo transplantation within 6 months * Model for end-stage liver disease (MELD) score of \…