AST-120 Used to Treat Mild Hepatic Encephalopathy (NCT00867698) | Clinical Trial Compass
CompletedPhase 2
AST-120 Used to Treat Mild Hepatic Encephalopathy
United States148 participantsStarted 2009-03
Plain-language summary
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Confirmed cirrhosis of any cause
. Abnormal RBANS global summary score
. Grade 0 or 1 hepatic encephalopathy by West-Haven Scale
. MELD score \< or = 25
. Females must be postmenopausal, surgically incapable of bearing children or practicing a reliable method of birth control
Exclusion criteria
. Previous participation in any trial involving AST-120
. History of TIPS or surgically created portocaval shunt
. Treatment for overt HE within the past 3 months
. Use of lactulose, rifaximin, neomycin or other antibiotics in the past 7 days
. Active alcohol abuse
. Psychosis or organic brain syndromes due to alcohol or other causes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.