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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 compared to lactulose in patients with mild hepatic encephalopathy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocera Therapeutics
• Treatments: Lactulose

Criteria

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.

Exclusion Criteria:

• Patients whose condition necessitates continuous administration of antibiotics (e.g. rifaximin, neomycin, metronidazole)

• Patients undergoing chemotherapy for treatment of cancer (patients with hepatocellular carcinoma being treated by methods other than chemotherapy may be enrolled)

• Patients who require continued treatment with narcotics or sedatives

• Patients who have active GI bleeding

• Patients who have an active infection

• Patients who have signs and symptoms of severe dehydration

• Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling

• Unable to attend all visits required by the protocol

• Female patients must be EXCLUDED if they are pregnant, breast feeding, planning to become pregnant during the study or using hormonal contraception as their only method of birth control