Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy (NCT00558038) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy
United States40 participantsStarted 2007-09
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 cond…