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.

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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
✕. Use of interferon and sedating or cognition-altering drugs
✕. Undergoing chemotherapy or radiotherapy for the treatment of cancer

Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.

Timeframe: 8 weeks

NCT IDNCT00867698

SponsorOcera Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-04