AST-120 Used to Treat Mild Hepatic Encephalopathy

Study Overview
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Brief Summary
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The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.

Official Title
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A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy, Safety and Tolerability of AST-120 (Spherical Carbon Adsorbent) for 8 Weeks in the Treatment of Mild Hepatic Encephalopathy

Conditions
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Mild Hepatic Encephalopathy

Intervention / Treatment
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* Drug: AST-120


Participation Criteria
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Eligibility Criteria
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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 Use of interferon and sedating or cognition-altering drugs Undergoing chemotherapy or radiotherapy for the treatment of cancer Active GI bleeding within the past 3 months Presence of an active infection Presence of signs and symptoms of severe dehydration Other major physical or major psychiatric illness within the past 6 months Pregnant, breast feeding, or planning to become pregnant during the study Using hormonal contraception as the only method of birth control

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AST-120 (6g)<br>2 grams TID | Drug: AST-120<br>* AST-120<br>* Other names: Spherical carbon adsorbent;|
| Placebo Comparator: Placebo A<br>2 grams TID | Drug: AST-120<br>* AST-120<br>* Other names: Spherical carbon adsorbent;|
| Experimental: AST-120 (12g)<br>4 grams TID | Drug: AST-120<br>* AST-120<br>* Other names: Spherical carbon adsorbent;|
| Placebo Comparator: Placebo B<br>4 grams TID | Drug: AST-120<br>* AST-120<br>* Other names: Spherical carbon adsorbent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline. |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic encephalopathy, Mild hepatic encephalopathy, HE, MHE, Cognitive impairment, Cognitive dysfunction, Liver Disease, Cirrhosis