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

Completed · Phase 2

Conditions studied: Hepatic Encephalopathy

In brief

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.

Key facts

Study ID

NCT00558038

Run by

Ocera Therapeutics

People needed

40

Starts

2007-09-01

Expected to finish

2009-06-01

Last updated by the study team

2014-05-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Scripps Clinic — San Diego, California, United States
• Veterans Medical Center San Diego — San Diego, California, United States
• Washington Hospital Center - MedStar Research Institute — Washington D.C., District of Columbia, United States
• Digestive Healthcare of Georgia — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• University of Massachusetts Medical School — Worchester, Massachusetts, United States
• Weill Medical College of Cornell — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Baylor University Medical Center — Houston, Texas, United States
• St. Luke's Advanced Liver Therapies / St. Luke's Texas Liver Coalition - Baylor College of Medicine — Houston, Texas, United States
• Metropolitan Research — Fairfax, Virginia, United States
• McGuire VA Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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