Mild Hepatic Encephalopathy
Conditions
Keywords
Hepatic encephalopathy, Mild hepatic encephalopathy, HE, MHE, Cognitive impairment, Cognitive dysfunction, Liver Disease, Cirrhosis
Brief summary
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
Interventions
DRUGAST-120
AST-120
Sponsors
Ocera Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmed cirrhosis of any cause 2. Abnormal RBANS global summary score 3. Grade 0 or 1 hepatic encephalopathy by West-Haven Scale 4. MELD score \< or = 25 5. Females must be postmenopausal, surgically incapable of bearing children or practicing a reliable method of birth control
Exclusion criteria
1. Previous participation in any trial involving AST-120 2. History of TIPS or surgically created portocaval shunt 3. Treatment for overt HE within the past 3 months 4. Use of lactulose, rifaximin, neomycin or other antibiotics in the past 7 days 5. Active alcohol abuse 6. Psychosis or organic brain syndromes due to alcohol or other causes 7. Use of interferon and sedating or cognition-altering drugs 8. Undergoing chemotherapy or radiotherapy for the treatment of cancer 9. Active GI bleeding within the past 3 months 10. Presence of an active infection 11. Presence of signs and symptoms of severe dehydration 12. Other major physical or major psychiatric illness within the past 6 months 13. Pregnant, breast feeding, or planning to become pregnant during the study 14. Using hormonal contraception as the only method of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline. | 8 weeks |
Countries
United States
Outcome results
None listed