AST-120 Used to Treat Mild Hepatic Encephalopathy

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocera Therapeutics

Criteria

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