AST-120 Used to Treat Mild Hepatic Encephalopathy (ASTUTE)

Ocera Therapeutics

Status and phase: Completed; Phase 2

Conditions: Mild Hepatic Encephalopathy

Treatments: Drug: AST-120

Study type: Interventional

Funder types: Industry

Identifiers

NCT00867698

AST-MHE201

Details and patient eligibility

About

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

Enrollment: 148 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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148 participants in 4 patient groups, including a placebo group

AST-120 (6g)

Experimental group

Description:

2 grams TID

Treatment:

Drug: AST-120

Placebo A

Placebo Comparator group

Description:

2 grams TID

Treatment:

Drug: AST-120

AST-120 (12g)

Experimental group

Description:

4 grams TID

Treatment:

Drug: AST-120

Placebo B

Placebo Comparator group

Description:

4 grams TID

Treatment:

Drug: AST-120