Status:
COMPLETED
AST-120 Used to Treat Mild Hepatic Encephalopathy
Lead Sponsor:
Ocera Therapeutics
Conditions:
Mild Hepatic Encephalopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00867698
Start Date
March 1 2009
End Date
June 1 2010
Last Update
June 18 2014
Active Locations (38)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
3
UCSF - Fresno Community Regional Medical Center
Fresno, California, United States, 93721
4
UCSD Medical Center
La Jolla, California, United States, 92161