AST-120 Used to Treat Mild Hepatic Encephalopathy
- Registration Number
- NCT00867698
- Lead Sponsor
- Ocera Therapeutics
- Brief Summary
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AST-120 (6g) AST-120 2 grams TID Placebo A AST-120 2 grams TID AST-120 (12g) AST-120 4 grams TID Placebo B AST-120 4 grams TID
- Primary Outcome Measures
Name Time Method Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline. 8 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Beth Israel Deaconnes Medical Center, Harvard Medical School
🇺🇸Boston, Massachusetts, United States
Albert Einstein Medical Center, Division of Hepatology
🇺🇸Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Case Western Reserve / MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Scripps Clinic
🇺🇸San Diego, California, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Northwestern University, Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
University of Cincinatti
🇺🇸Cincinatti, Ohio, United States
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
UCSF - Fresno Community Regional Medical Center
🇺🇸Fresno, California, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
UCSD Medical Center
🇺🇸San Diego, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
VA Medical Center / University of Iowa Hospital and Clinics
🇺🇸Iowa City, Iowa, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Weill Medical College of Cornell
🇺🇸New York, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of Southern Carolina
🇺🇸Charleston, South Carolina, United States
Advanced Liver Therapies, St. Luke's Episcopal Hospital/Baylor College of Medicine
🇺🇸Houston, Texas, United States
Permian Research Foundation
🇺🇸Odessa, Texas, United States
McGuire DVAMC
🇺🇸Richmond, Virginia, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of Miami, Division of Hepatology / Center for Liver Disease
🇺🇸Miami, Florida, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Delta Research Partners, LLC
🇺🇸Monroe, Louisiana, United States