Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
148 participants
INTERVENTIONAL
2009-03-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AST-120 (6g)
2 grams TID
AST-120
AST-120
Placebo A
2 grams TID
AST-120
AST-120
AST-120 (12g)
4 grams TID
AST-120
AST-120
Placebo B
4 grams TID
AST-120
AST-120
Interventions
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AST-120
AST-120
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Ocera Therapeutics
INDUSTRY
Responsible Party
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Ocera Therapeutics
Principal Investigators
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Jeff Bornstein, MD
Role: STUDY_DIRECTOR
Ocera Therapeutics, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
UCSF - Fresno Community Regional Medical Center
Fresno, California, United States
UCSD Medical Center
La Jolla, California, United States
Scripps Clinic
San Diego, California, United States
UCSD Medical Center
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida College of Medicine
Gainesville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of Miami, Division of Hepatology / Center for Liver Disease
Miami, Florida, United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
VA Medical Center / University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Louisville
Louisville, Kentucky, United States
Delta Research Partners, LLC
Monroe, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconnes Medical Center, Harvard Medical School
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Weill Medical College of Cornell
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
New York Medical College
Valhalla, New York, United States
University of Cincinatti
Cincinnati, Ohio, United States
Case Western Reserve / MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center, Division of Hepatology
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of Southern Carolina
Charleston, South Carolina, United States
Baylor University Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, 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
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
McGuire DVAMC
Richmond, Virginia, United States
Countries
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Other Identifiers
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AST-MHE201
Identifier Type: -
Identifier Source: org_study_id
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