Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy

Inclusion Criteria

• •Patients with End Stage Liver Disease secondary to any cause (patients who have undergone portosystemic shunting (TIPS) procedure \> 3 months prior to randomization can be included)
• •Lactulose naïve patients or patients currently on an established dose of lactulose
• •MELD score ≤ 15 (MELD score up to 20 is allowable if it has remained stable for at least 3 months)
• •Meet the criteria for Stage 1-2 hepatic encephalopathy according to the Westhaven Scale
• •Patients must have discontinued rifaximin or other oral antibiotics for at least 48 hours prior to randomization
• •Able and willing to comply with all protocol procedures for the planned duration of the study
• •Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information
• •Have a person (spouse, relative, or friend) willing to accompany the patient to the study visits (patients in this condition are not recommended to drive a vehicle)
• •Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (intrauterine devices, spermicide and barrier). Partner/spouse sterility may also qualify at the investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline.
• •Note: Patients already on lactulose and randomized to AST-120 will stop taking lactulose on the day they begin taking AST-120.