AST-120 Used to Treat Mild Hepatic Encephalopathy
ASTUTE
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy, Safety and Tolerability of AST-120 (Spherical Carbon Adsorbent) for 8 Weeks in the Treatment of Mild Hepatic Encephalopathy
1 other identifier
interventional
148
1 country
38
Brief Summary
The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2009
Shorter than P25 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 20, 2009
CompletedFirst Posted
Study publicly available on registry
March 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJune 18, 2014
June 1, 2014
1.1 years
March 20, 2009
June 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.
8 weeks
Study Arms (4)
AST-120 (6g)
EXPERIMENTAL2 grams TID
Placebo A
PLACEBO COMPARATOR2 grams TID
AST-120 (12g)
EXPERIMENTAL4 grams TID
Placebo B
PLACEBO COMPARATOR4 grams TID
Interventions
AST-120
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
UCSF - Fresno Community Regional Medical Center
Fresno, California, 93721, United States
UCSD Medical Center
La Jolla, California, 92161, United States
Scripps Clinic
San Diego, California, 92037, United States
UCSD Medical Center
San Diego, California, 92101, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida College of Medicine
Gainesville, Florida, 32610, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
University of Miami, Division of Hepatology / Center for Liver Disease
Miami, Florida, 33136, United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
VA Medical Center / University of Iowa Hospital and Clinics
Iowa City, Iowa, 52246, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Delta Research Partners, LLC
Monroe, Louisiana, 71201, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconnes Medical Center, Harvard Medical School
Boston, Massachusetts, 02215, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Weill Medical College of Cornell
New York, New York, 10021, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
New York Medical College
Valhalla, New York, 10595, United States
University of Cincinatti
Cincinnati, Ohio, 45267, United States
Case Western Reserve / MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Albert Einstein Medical Center, Division of Hepatology
Philadelphia, Pennsylvania, 19141, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of Southern Carolina
Charleston, South Carolina, 29425, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
UT Southwestern Medical Center
Dallas, Texas, 75390-9151, United States
Advanced Liver Therapies, St. Luke's Episcopal Hospital/Baylor College of Medicine
Houston, Texas, 77030, United States
Permian Research Foundation
Odessa, Texas, 79761, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
McGuire DVAMC
Richmond, Virginia, 23249, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeff Bornstein, MD
Ocera Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 20, 2009
First Posted
March 24, 2009
Study Start
March 1, 2009
Primary Completion
April 1, 2010
Study Completion
June 1, 2010
Last Updated
June 18, 2014
Record last verified: 2014-06