AST-120 Used to Treat Mild Hepatic Encephalopathy

Completed · Phase 2 · Has a placebo group

Conditions studied: Mild Hepatic Encephalopathy

In brief

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

Key facts

Study ID

NCT00867698

Run by

Ocera Therapeutics

People needed

148

Starts

2009-03-01

Expected to finish

2010-06-01

Last updated by the study team

2014-06-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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